ILab 600 - 650 instructions

rev 425.0.2 - 2010-09-01

Chema Diagnostica
Via Campania 2/4
I-60030 Monsano | An Italy
T +39 0731 605064 | F +39 0731 605672
www.chema.com | mail@chema.com

Chema Diagnostica - Guidelines for automatic analyzers - Ilab 600 - 650

ILab 600 - 650 instructions

rev 425.0.2 - 2010-09-01
Warning!
These programs should be used only as guideline.
To check the reagent correct setting on the
instrument, use only good quality control sera
and work accordingly to with good laboratory
practice. Instrumental factor must be checked.
Chema Diagnostica will not be responsible for
instrumental bad programming.

IUS.425.0.2

Directions for use

Edition 2010-09-01

page 3 of 41

Chema Diagnostica - Guidelines for automatic analyzers - Ilab 600 - 650

Analyzer:

Application:

Preparation:


Storage:

Ilab 600 - 650

ACID PHOSPHATASE - Codes AC 0120 TC
POWDER SINGLE REAGENT. FOLLOW PREPARATION PROGRAM INDICATED IN INSERT
SHEET. INSTALL AS R1
REFRIGERATE AT 2-8C

Photometric Test Parameters

Serum

Test no.
Test Name, Test Code
Sample Type
Reporting Units, Dec. Points
Reaction Cycle
Twin Analysis
Method. Type, Meas. Point
Photometric Methodology
Primary/Secondary Wav.

**
ACP-T
Serum
U/L, 1
Standard
OFF
Rate, 19/33
1 Wavelenght
405

Sampling Conditions
Sampling 1 Smp. Vol.

Smp./Dil. Vol.
Sampling 2 Smp.Vol.

Smp./Dil.Vol.
Sampling 3 and Sampling 4
Diluent Code
Diluent Warning Limit
First Run
Below/Above Normal Range
Panic L
Panic H
Noise
Prozone
HIGH!, ABS

30
0/0
15
0/0
***
Water
N/A
Sampling 1
***
***
Sampling 2
***
N/A
Sampling 2

Serum

Normal range-Male
Normal range-Female
Normal range-Other
Valid Range
Hem./Icterus/Lip. Lmt.
Reaction Slope
Absorbance Limit,
Prozone Limit
Non Linear Limit
Slope/Intercept Corr.
Qualitative Report

0.0 - 4.7
**
**
0 - 75
***
Positive
Above, 3000
N/A
40
1/0
OFF

Calib. Conditions
(option 1: K-factor)
Calibration
Stability (days)
Calibrator, Conc.
R-Blank Limit (mAbs)
Cal. Reps Range (%)
Min. Cal. Resp. (mAbs)
Cal. Factor Change (%)
M-Point Curve Fit (%)
Auto R-Blank by Bottle

Code
Rgt/Dil. Vol., Stir.
Low Vol. W/ Limit
Stability (days)
Code
Rgt/Dil. Vol., Stir.
Low Vol. W/ Limit
Stability (days)

**
300/0, yes
***
10
N/A
N/A
N/A
N/A

Calibration
Stability (days)
Calibrator, Conc.
R-Blank Limit (mAbs)
Cal. Reps Range (%)
Min. Cal. Resp. (mAbs)
Cal. Factor Change (%)
M-Point Curve Fit (%)
Auto R-Blank by Bottle

Note:
*
**
***
N/A

IUS.425.0.2

Factor: 743, 3 Reps

N/A
N/A
***
N/A
N/A
N/A
N/A
ON

Calib. Conditions
(option 2: calibrator)

Reagent Volumes
R1



R2

Ranges and Eval.

Criteria

Directions for use

1 Point, Linear, 3 Reps

10
Autocal H, *
***
***
***
***
N/A
ON

see the lot-assigned value

user defined
optional
not applicable

Edition 2010-09-01

page 4 of 41

Chema Diagnostica - Guidelines for automatic analyzers - Ilab 600 - 650

Analyzer:

Ilab 600 - 650

Application:
Preparation:
Storage:
Stability:

ALBUMIN - Code BC 0100 - 0500 - 1000 - 1500 CH

R1 - LIQUID READY TO USE SINGLE REAGENT
ROOM TEMPERATURE OR REFRIGERATE (2-30C)
AS INDICATED IN THE LABEL

Photometric Test Parameters

Serum

Test no.
Test Name, Test Code
Sample Type
Reporting Units, Dec. Points
Reaction Cycle
Twin Analysis
Method. Type, Meas. Point
Photometric Methodology
Primary/Secondary Wav.

**
ALB
Serum
g/dl, 1
Standard
OFF
End Point, 8
2 Wavelenght
600/700

Ranges and Eval. Criteria

Normal range-Male
Normal range-Female
Normal range-Other
Valid Range
Hem./Icterus/Lip. Lmt.
Reaction Slope
Absorbance Limit,
Prozone Limit
Non Linear Limit
Slope/Intercept Corr.
Qualitative Report

Serum
3.8 - 5.1
3.8 - 5.1
**
0.5 - 8.0
***
Positive
Above, 4000
N/A
N/A
1/0
OFF

Sampling Conditions
Sampling 1 Smp. Vol.

Smp./Dil. Vol.
Sampling 2 Smp.Vol.

Smp./Dil.Vol.
Sampling 3 and Sampling 4
Diluent Code
Diluent Warning Limit
First Run
Below/Above Normal Range
Panic L
Panic H
Noise
Prozone
HIGH!, ABS

3
0/0
2
0/0
***
Water
N/A
Sampling 1
***
***
Sampling 2
***
N/A
Sampling 2

Calibration Conditions
Calibration
Stability (days)
Calibrator, Conc.
R-Blank Limit (mAbs)
Cal. Reps Range (%)
Min. Cal. Resp. (mAbs)
Cal. Factor Change (%)
M-Point Curve Fit (%)
Auto R-Blank by Bottle

1 Point, Linear, 3 Reps

10
Autocal H, *
***
***
***
***
N/A
ON

Reagent Volumes
R1



R2

Code
Rgt/Dil. Vol., Stir.
Low Vol. W/ Limit
Stability (days)
Code
Rgt/Dil. Vol., Stir.
Low Vol. W/ Limit
Stability (days)

**
300/0, yes
***
60
N/A
N/A
N/A
N/A

Note:
*
**
***
N/A

IUS.425.0.2

Directions for use

see the lot-assigned value

user defined
optional
not applicable

Edition 2010-09-01

page 5 of 41

Chema Diagnostica - Guidelines for automatic analyzers - Ilab 600 - 650

Analyzer:

Application:

Preparation:


Storage:

Stability:

Ilab 600 - 650

ALKALINE PHOSPHATASE FL DGKC - Codes AL F080 / F245 / F400 / F600 CH
R1 - INSTALL LIQUID READY TO USE REAGENT A
R2 - INSTALL LIQUID READY TO USE REAGENT B
REFRIGERATE AT 2-8C
AS INDICATED IN THE LABEL

Photometric Test Parameters

Serum

Test no.
Test Name, Test Code
Sample Type
Reporting Units, Dec. Points
Reaction Cycle
Twin Analysis
Method. Type, Meas. Point
Photometric Methodology
Primary/Secondary Wav.

**
ALP
Serum
U/L, O
Standard
OFF
Rate, 21/27
1 Wavelenght
405

Sampling Conditions
Sampling 1 Smp. Vol.

Smp./Dil. Vol.
Sampling 2 Smp.Vol.

Smp./Dil.Vol.
Sampling 3 and Sampling 4
Diluent Code
Diluent Warning Limit
First Run
Below/Above Normal Range
Panic L
Panic H
Noise
Prozone
HIGH!, ABS

5
0/0
3
0/0
***
Water
N/A
Sampling 1
***
***
Sampling 2
***
N/A
Sampling 2

Serum

Normal range-Male
Normal range-Female
Normal range-Other
Valid Range
Hem./Icterus/Lip. Lmt.
Reaction Slope
Absorbance Limit,
Prozone Limit
Non Linear Limit
Slope/Intercept Corr.
Qualitative Report

64 - 306
80 - 306
**
5 - 2000
***
Positive
Above, 4000
N/A
40
1/0
OFF

Calib. Conditions
(option 1: K-factor)
Calibration
Stability (days)
Calibrator, Conc.
R-Blank Limit (mAbs)
Cal. Reps Range (%)
Min. Cal. Resp. (mAbs)
Cal. Factor Change (%)
M-Point Curve Fit (%)
Auto R-Blank by Bottle

Code
Rgt/Dil. Vol., Stir.
Low Vol. W/ Limit
Stability (days)
Code
Rgt/Dil. Vol., Stir.
Low Vol. W/ Limit
Stability (days)

**
250/0, yes
***
14
**
62/0, yes
***
14

Calibration
Stability (days)
Calibrator, Conc.
R-Blank Limit (mAbs)
Cal. Reps Range (%)
Min. Cal. Resp. (mAbs)
Cal. Factor Change (%)
M-Point Curve Fit (%)
Auto R-Blank by Bottle

Note:
*
**
***
N/A

IUS.425.0.2

Factor: 3.433, 3 Reps

N/A
N/A
***
N/A
N/A
N/A
N/A
ON

Calib. Conditions
(option 2: calibrator)

Reagent Volumes
R1



R2

Ranges and Eval.

Criteria

Directions for use

1 Point, Linear, 3 Reps

14
Autocal H, *
***
***
***
***
N/A
ON

see the lot-assigned value

user defined
optional
not applicable

Edition 2010-09-01

page 6 of 41

Chema Diagnostica - Guidelines for automatic analyzers - Ilab 600 - 650

Analyzer:

Application:

Preparation:


Storage:

Stability:

Ilab 600 - 650

ALKALINE PHOSPHATASE FL IFCC - Codes AF F080 / F245 / F400 / F600 CH
R1 - INSTALL LIQUID READY TO USE REAGENT A
R2 - INSTALL LIQUID READY TO USE REAGENT B
REFRIGERATE AT 2-8C
AS INDICATED IN THE LABEL

Photometric Test Parameters

Serum

Test no.
Test Name, Test Code
Sample Type
Reporting Units, Dec. Points
Reaction Cycle
Twin Analysis
Method. Type, Meas. Point
Photometric Methodology
Primary/Secondary Wav.

**
ALP
Serum
U/L, O
Standard
OFF
Rate, 21/27
1 Wavelenght
405

Sampling Conditions
Sampling 1 Smp. Vol.

Smp./Dil. Vol.
Sampling 2 Smp.Vol.

Smp./Dil.Vol.
Sampling 3 and Sampling 4
Diluent Code
Diluent Warning Limit
First Run
Below/Above Normal Range
Panic L
Panic H
Noise
Prozone
HIGH!, ABS

5
0/0
3
0/0
***
Water
N/A
Sampling 1
***
***
Sampling 2
***
N/A
Sampling 2

Serum

Normal range-Male
Normal range-Female
Normal range-Other
Valid Range
Hem./Icterus/Lip. Lmt.
Reaction Slope
Absorbance Limit,
Prozone Limit
Non Linear Limit
Slope/Intercept Corr.
Qualitative Report

35 - 104
40 - 129
**
5 - 3000
***
Positive
Above, 4000
N/A
40
1/0
OFF

Calib. Conditions
(option 1: K-factor)
Calibration
Stability (days)
Calibrator, Conc.
R-Blank Limit (mAbs)
Cal. Reps Range (%)
Min. Cal. Resp. (mAbs)
Cal. Factor Change (%)
M-Point Curve Fit (%)
Auto R-Blank by Bottle

Code
Rgt/Dil. Vol., Stir.
Low Vol. W/ Limit
Stability (days)
Code
Rgt/Dil. Vol., Stir.
Low Vol. W/ Limit
Stability (days)

**
250/0, yes
***
14
**
62/0, yes
***
14

Calibration
Stability (days)
Calibrator, Conc.
R-Blank Limit (mAbs)
Cal. Reps Range (%)
Min. Cal. Resp. (mAbs)
Cal. Factor Change (%)
M-Point Curve Fit (%)
Auto R-Blank by Bottle

Note:
*
**
***
N/A

IUS.425.0.2

Factor: 3.433, 3 Reps

N/A
N/A
***
N/A
N/A
N/A
N/A
ON

Calib. Conditions
(option 2: calibrator)

Reagent Volumes
R1



R2

Ranges and Eval.

Criteria

Directions for use

1 Point, Linear, 3 Reps

14
Autocal H, *
***
***
***
***
N/A
ON

see the lot-assigned value

user defined
optional
not applicable

Edition 2010-09-01

page 7 of 41

Chema Diagnostica - Guidelines for automatic analyzers - Ilab 600 - 650

Analyzer:

Ilab 600 - 650

Application:
Preparation:
Storage:
Stability:

AMYLASE FL - Codes AM F060 / F120 / F245 CH

R1 - LIQUID READY TO USE SINGLE REAGENT
REFRIGERATE AT 2-8C
AS INDICATED IN THE LABEL

Photometric Test Parameters

Serum

Urine

Test no.
Test Name, Test Code
Sample Type
Reporting Units, Dec. Points

**
AMY
Serum
U/L, 0

**
AMY UR
Urine
U/L, 0

Reaction Cycle
Twin Analysis
Method. Type, Meas. Point
Photometric Methodology
Primary/Secondary Wav.

Standard
OFF
Rate 6/17
1 Wavelenght
405

Standard
OFF
Rate 6/17
1 Wavelenght
405

8
0/0
8
10/90
***
Water
N/A
Sampling 1
***
***
Sampling 2
***
N/A
Sampling 2

8
20/80
8
10/90
***
Water
N/A
Sampling 1
***
***
Sampling 2
***
N/A
Sampling 2

Sampling Conditions
Sampling 1 Smp. Vol.

Smp./Dil. Vol.
Sampling 2 Smp.Vol.

Smp./Dil.Vol.
Sampling 3 and Sampling 4
Diluent Code
Diluent Warning Limit
First Run
Below/Above Normal Range
Panic L
Panic H
Noise
Prozone
HIGH!, ABS

Serum

Urine

Normal range-Male
Normal range-Female
Normal range-Other
Valid Range
Hem./Icterus/Lip. Lmt.
Reaction Slope
Absorbance Limit,
Prozone Limit
Non Linear Limit
Slope/Intercept Corr.
Qualitative Report

0 - 96
0 - 96
**
5 - 3000
***
Positive
Above, 4000
N/A
40
1/0
OFF

0 - 480
0 - 480
**
5 - 15000
***
Positive
Above, 4000
N/A
40
5/0
OFF

Factor: 3.178,
3 Reps
N/A
N/A
***
N/A
N/A
N/A
N/A
ON

Factor: 3.178,
3 Reps
N/A
N/A
***
N/A
N/A
N/A
N/A
ON

1 Point, Linear,
3 Reps
30
Autocal H, *
***
***
***
***
N/A
ON

K-Accept, Partner**,
Coeff: 5, 3 Reps
N/A
**
N/A
N/A
N/A
N/A
N/A
ON

Calib. Conditions
(option 1: K-factor)
Calibration

Stability (days)
Calibrator, Conc.
R-Blank Limit (mAbs)
Cal. Reps Range (%)
Min. Cal. Resp. (mAbs)
Cal. Factor Change (%)
M-Point Curve Fit (%)
Auto R-Blank by Bottle
Calib. Conditions
(option 2: calibrator)

Reagent Volumes
R1



R2

Ranges and Eval.

Criteria

Code
Rgt/Dil. Vol., Stir.
Low Vol. W/ Limit
Stability (days)
Code
Rgt/Dil. Vol., Stir.
Low Vol. W/ Limit
Stability (days)

**
320/0, yes
***
30
N/A
N/A
N/A
N/A

**
320/0, yes
***
30
N/A
N/A
N/A
N/A

Calibration

Stability (days)
Calibrator, Conc.
R-Blank Limit (mAbs)
Cal. Reps Range (%)
Min. Cal. Resp. (mAbs)
Cal. Factor Change (%)
M-Point Curve Fit (%)
Auto R-Blank by Bottle

NOTA: il metodo CNP-G3 non sempre disponibile tra i valori del calibratore.
In mancanza, utilizzare il valore EPS, programmando
i parametri come di seguito:
Normal range-Male
Normal range-Female
Valid Range

Note:
*
**
***
N/A

IUS.425.0.2

Directions for use

28 - 100
28 - 100
2 - 1500

see the lot-assigned value

user defined
optional
not applicable

Edition 2010-09-01

page 8 of 41

Chema Diagnostica - Guidelines for automatic analyzers - Ilab 600 - 650

Analyzer:

Application:

Preparation:


Storage:

Stability:

Ilab 600 - 650

AMYLASE EPS FL - Codes EA F080 / F245 CH
R1 - INSTALL LIQUID READY TO USE REAGENT A
R2 - INSTALL LIQUID READY TO USE REAGENT B
REFRIGERATE AT 2-8C
AS INDICATED IN THE LABEL

Photometric Test Parameters

Serum

Urine

Test no.
Test Name, Test Code
Sample Type
Reporting Units, Dec. Points

**
AMY
Serum
U/L, 0

**
AMY UR
Urine
U/L, 0

Reaction Cycle
Twin Analysis
Method. Type, Meas. Point
Photometric Methodology
Primary/Secondary Wav.

Standard
OFF
Rate 21/27
1 Wavelenght
405

Standard
OFF
Rate 21/27
1 Wavelenght
405

10
0/0
10
10/90
***
Water
N/A
Sampling 1
***
***
Sampling 2
***
N/A
Sampling 2

10
20/80
10
10/90
***
Water
N/A
Sampling 1
***
***
Sampling 2
***
N/A
Sampling 2

Sampling Conditions
Sampling 1 Smp. Vol.

Smp./Dil. Vol.
Sampling 2 Smp.Vol.

Smp./Dil.Vol.
Sampling 3 and Sampling 4
Diluent Code
Diluent Warning Limit
First Run
Below/Above Normal Range
Panic L
Panic H
Noise
Prozone
HIGH!, ABS

Serum

Urine

Normal range-Male
Normal range-Female
Normal range-Other
Valid Range
Hem./Icterus/Lip. Lmt.
Reaction Slope
Absorbance Limit,
Prozone Limit
Non Linear Limit
Slope/Intercept Corr.
Qualitative Report

28 - 100
28 - 100
**
5 - 1500
***
Positive
Above, 4000
N/A
40
1/0
OFF

0 - 460
0 - 160
**
5 - 7500
***
Positive
Above, 4000
N/A
40
5/0
OFF

Factor: 3480,
3 Reps
N/A
N/A
***
N/A
N/A
N/A
N/A
ON

Factor: 3480,
3 Reps
N/A
N/A
***
N/A
N/A
N/A
N/A
ON

1 Point, Linear,
3 Reps
30
Autocal H, *
***
***
***
***
N/A
ON

K-Accept, Partner**,
Coeff: 5, 3 Reps
N/A
**
N/A
N/A
N/A
N/A
N/A
ON

Calib. Conditions
(option 1: K-factor)
Calibration

Stability (days)
Calibrator, Conc.
R-Blank Limit (mAbs)
Cal. Reps Range (%)
Min. Cal. Resp. (mAbs)
Cal. Factor Change (%)
M-Point Curve Fit (%)
Auto R-Blank by Bottle
Calib. Conditions
(option 2: calibrator)

Reagent Volumes
R1



R2

Ranges and Eval.

Criteria

Code
Rgt/Dil. Vol., Stir.
Low Vol. W/ Limit
Stability (days)
Code
Rgt/Dil. Vol., Stir.
Low Vol. W/ Limit
Stability (days)

**
240/0, yes
***
30
**
60/0, yes
***
30

**
240/0, yes
***
30
**
60/0, yes
***
30

Calibration

Stability (days)
Calibrator, Conc.
R-Blank Limit (mAbs)
Cal. Reps Range (%)
Min. Cal. Resp. (mAbs)
Cal. Factor Change (%)
M-Point Curve Fit (%)
Auto R-Blank by Bottle

Note:
*
**
***
N/A

IUS.425.0.2

Directions for use

see the lot-assigned value

user defined
optional
not applicable

Edition 2010-09-01

page 9 of 41

Chema Diagnostica - Guidelines for automatic analyzers - Ilab 600 - 650

Analyzer:

Application:

Preparation:


Storage:

Stability:

Ilab 600 - 650

PANCREATIC ISOAMYLASE FL - Code PA F080 / F245 CH
R1 - INSTALL LIQUID READY TO USE REAGENT A
R2 - INSTALL LIQUID READY TO USE REAGENT B
REFRIGERATE AT 2-8C
AS INDICATED IN THE LABEL

Photometric Test Parameters

Serum

Urine

Test no.
Test Name, Test Code
Sample Type
Reporting Units, Dec. Points

**
PANC
Serum
U/L, 0

**
PANC UR
Urine
U/L, 0

Reaction Cycle
Twin Analysis
Method. Type, Meas. Point
Photometric Methodology
Primary/Secondary Wav.

Standard
OFF
Rate 21/27
1 Wavelenght
405

Standard
OFF
Rate 21/27
1 Wavelenght
405

6
0/0
6
10/90
***
Water
N/A
Sampling 1
***
***
Sampling 2
***
N/A
Sampling 2

6
20/80
6
10/90
***
Water
N/A
Sampling 1
***
***
Sampling 2
***
N/A
Sampling 2

Sampling Conditions
Sampling 1 Smp. Vol.

Smp./Dil. Vol.
Sampling 2 Smp.Vol.

Smp./Dil.Vol.
Sampling 3 and Sampling 4
Diluent Code
Diluent Warning Limit
First Run
Below/Above Normal Range
Panic L
Panic H
Noise
Prozone
HIGH!, ABS

Serum

Urine

Normal range-Male
Normal range-Female
Normal range-Other
Valid Range
Hem./Icterus/Lip. Lmt.
Reaction Slope
Absorbance Limit,
Prozone Limit
Non Linear Limit
Slope/Intercept Corr.
Qualitative Report

13 - 53
13 - 53
**
5 - 2500
***
Positive
Above, 4000
N/A
40
1/0
OFF

0 - 350
0 - 350
**
5 - 12500
***
Positive
Above, 4000
N/A
40
5/0
OFF

Factor: 6280,
3 Reps
N/A
N/A
***
N/A
N/A
N/A
N/A
ON

Factor: 6280,
3 Reps
N/A
N/A
***
N/A
N/A
N/A
N/A
ON

1 Point, Linear,
3 Reps
30
Autocal H, *
***
***
***
***
N/A
ON

K-Accept, Partner**,
Coeff: 5, 3 Reps
N/A
**
N/A
N/A
N/A
N/A
N/A
ON

Calib. Conditions
(option 1: K-factor)
Calibration

Stability (days)
Calibrator, Conc.
R-Blank Limit (mAbs)
Cal. Reps Range (%)
Min. Cal. Resp. (mAbs)
Cal. Factor Change (%)
M-Point Curve Fit (%)
Auto R-Blank by Bottle
Calib. Conditions
(option 2: calibrator)

Reagent Volumes
R1



R2

Ranges and Eval.

Criteria

Code
Rgt/Dil. Vol., Stir.
Low Vol. W/ Limit
Stability (days)
Code
Rgt/Dil. Vol., Stir.
Low Vol. W/ Limit
Stability (days)

**
240/0, yes
***
30
**
60/0, yes
***
30

**
240/0, yes
***
30
**
60/0, yes
***
30

Calibration

Stability (days)
Calibrator, Conc.
R-Blank Limit (mAbs)
Cal. Reps Range (%)
Min. Cal. Resp. (mAbs)
Cal. Factor Change (%)
M-Point Curve Fit (%)
Auto R-Blank by Bottle

Note:
*
**
***
N/A

IUS.425.0.2

Directions for use

see the lot-assigned value

user defined
optional
not applicable

Edition 2010-09-01

page 10 of 41

Chema Diagnostica - Guidelines for automatic analyzers - Ilab 600 - 650

Analyzer:

Ilab 600 - 650

Application:
Preparation:
Storage:
Stability:

BICARBONATE FL - Codes BR F060 / F245 / F400 CH

R1 - LIQUID READY TO USE SINGLE REAGENT
ROOM TEMPERATURE OR REFRIGERATE (2-30C)
AS INDICATED IN THE LABEL

Photometric Test Parameters

Serum

Test no.
Test Name, Test Code
Sample Type
Reporting Units, Dec. Points
Reaction Cycle
Twin Analysis
Method. Type, Meas. Point
Photometric Methodology
Primary/Secondary Wav.

**
BR
Serum
mmol/l, 1
Standard
OFF
End Point, 32
2 Wavelenght
415/505

Ranges and Eval. Criteria

Normal range-Male
Normal range-Female
Normal range-Other
Valid Range
Hem./Icterus/Lip. Lmt.
Reaction Slope
Absorbance Limit,
Prozone Limit
Non Linear Limit
Slope/Intercept Corr.
Qualitative Report

Serum
22 - 29
22 - 29
**
1 - 50
***
Positive
Above, 4000
N/A
N/A
1/0
OFF

Sampling Conditions
Sampling 1 Smp. Vol.

Smp./Dil. Vol.
Sampling 2 Smp.Vol.

Smp./Dil.Vol.
Sampling 3 and Sampling 4
Diluent Code
Diluent Warning Limit
First Run
Below/Above Normal Range
Panic L
Panic H
Noise
Prozone
HIGH!, ABS

3
0/0
2
0/0
***
Water
N/A
Sampling 1
***
***
Sampling 2
***
N/A
Sampling 2

Calibration Conditions
Calibration
Stability (days)
Calibrator, Conc.
R-Blank Limit (mAbs)
Cal. Reps Range (%)
Min. Cal. Resp. (mAbs)
Cal. Factor Change (%)
M-Point Curve Fit (%)
Auto R-Blank by Bottle

1 Point, Linear, 3 Reps

10
Standard, *
***
***
***
***
N/A
ON

Reagent Volumes
R1



R2

Code
Rgt/Dil. Vol., Stir.
Low Vol. W/ Limit
Stability (days)
Code
Rgt/Dil. Vol., Stir.
Low Vol. W/ Limit
Stability (days)

**
300/0, yes
***
60
N/A
N/A
N/A
N/A

Note:
*
**
***
N/A

IUS.425.0.2

Directions for use

see the lot-assigned value

user defined
optional
not applicable

Edition 2010-09-01

page 11 of 41

Chema Diagnostica - Guidelines for automatic analyzers - Ilab 600 - 650

Analyzer:

Application:

Preparation:


Storage:

Stability:

Ilab 600 - 650

BILIRUBIN TOTAL FL - Codes DT F125 / F500 CH
R1 - USE LIQUID READY TO USE REAGENT A
R2 - USE LIQUID READY TO USE REAGENT A
REFRIGERATE AT 2-8C
AS INDICATED IN THE LABEL

Photometric Test Parameters

Serum

Test no.
Test Name, Test Code
Sample Type
Reporting Units, Dec. Points
Reaction Cycle
Twin Analysis
Method. Type, Meas. Point
Photometric Methodology
Primary/Secondary Wav.

**
BILT FL
Serum
mg/dl, 2
Standard
OFF
End Point, 16/32
1 Wavelenght
510

Ranges and Eval. Criteria

Normal range-Male
Normal range-Female
Normal range-Other
Valid Range
Hem./Icterus/Lip. Lmt.
Reaction Slope
Absorbance Limit,
Prozone Limit
Non Linear Limit
Slope/Intercept Corr.
Qualitative Report

Serum
0.10 - 1.20
0.10 - 1.20
**
0.10 - 20.00
***
Positive
Above, 4000
N/A
N/A
1/0
OFF

Sampling Conditions
Sampling 1 Smp. Vol.

Smp./Dil. Vol.
Sampling 2 Smp.Vol.

Smp./Dil.Vol.
Sampling 3 and Sampling 4
Diluent Code
Diluent Warning Limit
First Run
Below/Above Normal Range
Panic L
Panic H
Noise
Prozone
HIGH!, ABS

15
0/0
10
0/0
***
Water
N/A
Sampling 1
***
***
Sampling 2
***
N/A
Sampling 2

Calibration Conditions
Calibration
Stability (days)
Calibrator, Conc.
R-Blank Limit (mAbs)
Cal. Reps Range (%)
Min. Cal. Resp. (mAbs)
Cal. Factor Change (%)
M-Point Curve Fit (%)
Auto R-Blank by Bottle

1 Point, Linear, 3 Reps

7
Autocal H, *
***
***
***
***
N/A
ON

Reagent Volumes
R1



R2

Code
Rgt/Dil. Vol., Stir.
Low Vol. W/ Limit
Stability (days)
Code
Rgt/Dil. Vol., Stir.
Low Vol. W/ Limit
Stability (days)

**
300/0, yes
***
10
**
75/0, yes
***
10

Note:
*
**
***
N/A

IUS.425.0.2

Directions for use

see the lot-assigned value

user defined
optional
not applicable

Edition 2010-09-01

page 12 of 41

Chema Diagnostica - Guidelines for automatic analyzers - Ilab 600 - 650

Analyzer:

Application:

Preparation:


Storage:

Stability:

Ilab 600 - 650

BILIRUBIN DIRECT FL - Codes DD F125 / F500 CH
R1 - USE LIQUID READY TO USE REAGENT A
R2 - USE LIQUID READY TO USE REAGENT A
REFRIGERATE AT 2-8C
AS INDICATED IN THE LABEL

Photometric Test Parameters

Serum

Test no.
Test Name, Test Code
Sample Type
Reporting Units, Dec. Points
Reaction Cycle
Twin Analysis
Method. Type, Meas. Point
Photometric Methodology
Primary/Secondary Wav.

**
BILD FL
Serum
mg/dl, 2
Standard
OFF
End Point, 16/32
1 Wavelenght
546

Ranges and Eval. Criteria

Normal range-Male
Normal range-Female
Normal range-Other
Valid Range
Hem./Icterus/Lip. Lmt.
Reaction Slope
Absorbance Limit,
Prozone Limit
Non Linear Limit
Slope/Intercept Corr.
Qualitative Report

Serum
0.00 - 0.2
0.00 - 0.2
**
0.00 - 13.00
***
Positive
Above, 4000
N/A
N/A
1/0
OFF

Sampling Conditions
Sampling 1 Smp. Vol.

Smp./Dil. Vol.
Sampling 2 Smp.Vol.

Smp./Dil.Vol.
Sampling 3 and Sampling 4
Diluent Code
Diluent Warning Limit
First Run
Below/Above Normal Range
Panic L
Panic H
Noise
Prozone
HIGH!, ABS

15
0/0
10
0/0
***
Water
N/A
Sampling 1
***
***
Sampling 2
***
N/A
Sampling 2

Calibration Conditions
Calibration
Stability (days)
Calibrator, Conc.
R-Blank Limit (mAbs)
Cal. Reps Range (%)
Min. Cal. Resp. (mAbs)
Cal. Factor Change (%)
M-Point Curve Fit (%)
Auto R-Blank by Bottle

1 Point, Linear, 3 Reps

7
Autocal H, *
***
***
***
***
N/A
ON

Reagent Volumes
R1



R2

Code
Rgt/Dil. Vol., Stir.
Low Vol. W/ Limit
Stability (days)
Code
Rgt/Dil. Vol., Stir.
Low Vol. W/ Limit
Stability (days)

**
300/0, yes
***
10
**
75/0, yes
***
10

Note:
*
**
***
N/A

IUS.425.0.2

Directions for use

see the lot-assigned value

user defined
optional
not applicable

Edition 2010-09-01

page 13 of 41

Chema Diagnostica - Guidelines for automatic analyzers - Ilab 600 - 650

Analyzer:

Ilab 600 - 650

Application:
Preparation:
Storage:
Stability:

CALCIUM ASX - Code CA 0100 - 0500 CH

R1 - LIQUID READY TO USE SINGLE REAGENT
ROOM TEMPERATURE OR REFRIGERATE (2-30C)
AS INDICATED IN THE LABEL

Photometric Test Parameters

Serum

Urine

Test no.
Test Name, Test Code
Sample Type
Reporting Units, Dec. Points

**
CA
Serum
mg/dl, 2

**
CA UR
Urine
mg/dl, 0

Reaction Cycle
Twin Analysis
Method. Type, Meas. Point
Photometric Methodology
Primary/Secondary Wav.

Standard
OFF
End Point, 28
2 Wavelenght
660/700

Standard
OFF
End Point, 28
2 Wavelenght
660/700

3
0/0
3
0/0
***
Water
N/A
Sampling 1
***
***
Sampling 2
***
N/A
Sampling 2

3
20/80
3
10/90
***
Water
N/A
Sampling 1
***
***
Sampling 2
***
N/A
Sampling 2

**
300/0, yes
***
30
N/A
N/A
N/A
N/A

**
300/0, yes
***
30
N/A
N/A
N/A
N/A

Ranges and Eval.

Criteria

Serum

Urine

Normal range-Male
Normal range-Female
Normal range-Other
Valid Range
Hem./Icterus/Lip. Lmt.
Reaction Slope
Absorbance Limit,
Prozone Limit
Non Linear Limit
Slope/Intercept Corr.
Qualitative Report

8.80 - 10.80
8.80 - 10.80
**
1.0 - 20.0
***
Positive
Above, 4000
N/A
N/A
1/0
OFF

**
**
**
2 - 120
***
Positive
Above, 4000
N/A
N/A
1/0
OFF

1 Point, Linear,
3 Reps
3
Autocal H, *
***
***
***
***
N/A
ON

K-Accept, Partner**,
Coeff: 5, 3 Reps
N/A
N/A
***
N/A
N/A
N/A
N/A
ON

Sampling Conditions
Sampling 1 Smp. Vol.

Smp./Dil. Vol.
Sampling 2 Smp.Vol.

Smp./Dil.Vol.
Sampling 3 and Sampling 4
Diluent Code
Diluent Warning Limit
First Run
Below/Above Normal Range
Panic L
Panic H
Noise
Prozone
HIGH!, ABS

Calibration Conditions
Calibration

Stability (days)
Calibrator, Conc.
R-Blank Limit (mAbs)
Cal. Reps Range (%)
Min. Cal. Resp. (mAbs)
Cal. Factor Change (%)
M-Point Curve Fit (%)
Auto R-Blank by Bottle

Reagent Volumes
R1



R2

Code
Rgt/Dil. Vol., Stir.
Low Vol. W/ Limit
Stability (days)
Code
Rgt/Dil. Vol., Stir.
Low Vol. W/ Limit
Stability (days)

Note:
*
**
***
N/A

IUS.425.0.2

Directions for use

see the lot-assigned value

user defined
optional
not applicable

Edition 2010-09-01

page 14 of 41

Chema Diagnostica - Guidelines for automatic analyzers - Ilab 600 - 650

Analyzer:

Application:

Preparation:


Storage:

Stability:

Ilab 600 - 650

CALCIUM - Code CA 0305 - 0505 CH
R1 - INSTALL LIQUID READY TO USE REAGENT B
R2 - INSTALL LIQUID READY TO USE REAGENT A
REFRIGERATE AT 2-8C
AS INDICATED IN THE LABEL

Photometric Test Parameters

Serum

Urine

Test no.
Test Name, Test Code
Sample Type
Reporting Units, Dec. Points

**
CA
Serum
mg/dl, 2

**
CA UR
Urine
mg/dl, 0

Reaction Cycle
Twin Analysis
Method. Type, Meas. Point
Photometric Methodology
Primary/Secondary Wav.

Standard
OFF
End Point, 28
2 Wavelenght
570/660

Standard
OFF
End Point, 28
2 Wavelenght
570/660

6
0/0
3
0/0
***
Water
N/A
Sampling 1
***
***
Sampling 2
***
N/A
Sampling 2

6
20/80
6
10/90
***
Water
N/A
Sampling 1
***
***
Sampling 2
***
N/A
Sampling 2

**
180/0, yes
***
30
**
180/0, yes
***
30

**
180/0, yes
***
30
**
180/0, yes
***
30

Ranges and Eval.

Criteria

Serum

Urine

Normal range-Male
Normal range-Female
Normal range-Other
Valid Range
Hem./Icterus/Lip. Lmt.
Reaction Slope
Absorbance Limit,
Prozone Limit
Non Linear Limit
Slope/Intercept Corr.
Qualitative Report

8.80 - 10.80
8.80 - 10.80
**
1.0 - 20.0
***
Positive
Above, 4000
N/A
N/A
1/0
OFF

**
**
**
2 - 120
***
Positive
Above, 4000
N/A
N/A
1/0
OFF

1 Point, Linear,
3 Reps
3
Autocal H, *
***
***
***
***
N/A
ON

K-Accept, Partner**,
Coeff: 5, 3 Reps
N/A
N/A
***
N/A
N/A
N/A
N/A
ON

Sampling Conditions
Sampling 1 Smp. Vol.

Smp./Dil. Vol.
Sampling 2 Smp.Vol.

Smp./Dil.Vol.
Sampling 3 and Sampling 4
Diluent Code
Diluent Warning Limit
First Run
Below/Above Normal Range
Panic L
Panic H
Noise
Prozone
HIGH!, ABS

Calibration Conditions
Calibration

Stability (days)
Calibrator, Conc.
R-Blank Limit (mAbs)
Cal. Reps Range (%)
Min. Cal. Resp. (mAbs)
Cal. Factor Change (%)
M-Point Curve Fit (%)
Auto R-Blank by Bottle

Reagent Volumes
R1



R2

Code
Rgt/Dil. Vol., Stir.
Low Vol. W/ Limit
Stability (days)
Code
Rgt/Dil. Vol., Stir.
Low Vol. W/ Limit
Stability (days)

Note:
*
**
***
N/A

IUS.425.0.2

Directions for use

see the lot-assigned value

user defined
optional
not applicable

Edition 2010-09-01

page 15 of 41

Chema Diagnostica - Guidelines for automatic analyzers - Ilab 600 - 650

Analyzer:

Ilab 600 - 650

Application:
Preparation:
Storage:
Stability:

CHOLESTEROL FL - Codes CT F100 / F400 / 100F / 150F CH

R1 - LIQUID READY TO USE SINGLE REAGENT
REFRIGERATE AT 2-8C
AS INDICATED IN THE LABEL

Photometric Test Parameters

Serum

Test no.
Test Name, Test Code
Sample Type
Reporting Units, Dec. Points
Reaction Cycle
Twin Analysis
Method. Type, Meas. Point
Photometric Methodology
Primary/Secondary Wav.

**
CHOL
Serum
mg/dl, 0
Standard
OFF
End Point, 33
2 Wavelenght
510/660

Ranges and Eval. Criteria

Normal range-Male
Normal range-Female
Normal range-Other
Valid Range
Hem./Icterus/Lip. Lmt.
Reaction Slope
Absorbance Limit,
Prozone Limit
Non Linear Limit
Slope/Intercept Corr.
Qualitative Report

Serum
140 - 200
140 - 200
**
10 - 800
***
Positive
Above, 4000
N/A
N/A
1/0
OFF

Sampling Conditions
Sampling 1 Smp. Vol.

Smp./Dil. Vol.
Sampling 2 Smp.Vol.

Smp./Dil.Vol.
Sampling 3 and Sampling 4
Diluent Code
Diluent Warning Limit
First Run
Below/Above Normal Range
Panic L
Panic H
Noise
Prozone
HIGH!, ABS

3
0/0
2
0/0
***
Water
N/A
Sampling 1
***
***
Sampling 2
***
N/A
Sampling 2

Calibration Conditions
Calibration
Stability (days)
Calibrator, Conc.
R-Blank Limit (mAbs)
Cal. Reps Range (%)
Min. Cal. Resp. (mAbs)
Cal. Factor Change (%)
M-Point Curve Fit (%)
Auto R-Blank by Bottle

1 Point, Linear, 3 Reps

10
Autocal H, *
***
***
***
***
N/A
ON

Reagent Volumes
R1



R2

Code
Rgt/Dil. Vol., Stir.
Low Vol. W/ Limit
Stability (days)
Code
Rgt/Dil. Vol., Stir.
Low Vol. W/ Limit
Stability (days)

**
300/0, yes
***
60
N/A
N/A
N/A
N/A

Note:
*
**
***
N/A

IUS.425.0.2

Directions for use

see the lot-assigned value

user defined
optional
not applicable

Edition 2010-09-01

page 16 of 41

Chema Diagnostica - Guidelines for automatic analyzers - Ilab 600 - 650

Analyzer:

Application:

Preparation:


Storage:

Stability:

Ilab 600 - 650

HDL DIRECT FL - Code HD F080 / F245 / F400 CH
R1 - USE LIQUID RFADY TO USE REAGENT A
R2 - USE LIQUID RFADY TO USE REAGENT B
REFRIGERATE AT 2-8C
AS INDICATED IN THE LABEL

Photometric Test Parameters

Serum

Test no.
Test Name, Test Code
Sample Type
Reporting Units, Dec. Points
Reaction Cycle
Twin Analysis
Method. Type, Meas. Point
Photometric Methodology
Primary/Secondary Wav.

**
HDL-C
Serum
mg/dl, 1
Standard
OFF
End Point, 33
2 Wavelenght
600/700

Ranges and Eval. Criteria

Normal range-Male
Normal range-Female
Normal range-Other
Valid Range
Hem./Icterus/Lip. Lmt.
Reaction Slope
Absorbance Limit,
Prozone Limit
Non Linear Limit
Slope/Intercept Corr.
Qualitative Report

Serum
35 - 79
42 - 88
**
5 - 220
***
Positive
Above, 3500
N/A
N/A
1/0
OFF

Sampling Conditions
Sampling 1 Smp. Vol.

Smp./Dil. Vol.
Sampling 2 Smp.Vol.

Smp./Dil.Vol.
Sampling 3 and Sampling 4
Diluent Code
Diluent Warning Limit
First Run
Below/Above Normal Range
Panic L
Panic H
Noise
Prozone
HIGH!, ABS

3
0/0
2
0/0
***
Water
N/A
Sampling 1
***
***
Sampling 2
***
N/A
Sampling 2

Calibration Conditions
Calibration
Stability (days)
Calibrator, Conc.
R-Blank Limit (mAbs)
Cal. Reps Range (%)
Min. Cal. Resp. (mAbs)
Cal. Factor Change (%)
M-Point Curve Fit (%)
Auto R-Blank by Bottle

1 Point, Linear, 3 Reps

10
Autocal H, *
***
***
***
***
N/A
ON

Reagent Volumes
R1



R2

Code
Rgt/Dil. Vol., Stir.
Low Vol. W/ Limit
Stability (days)
Code
Rgt/Dil. Vol., Stir.
Low Vol. W/ Limit
Stability (days)

**
270/0, yes
***
60
**
90/0, yes
***
60

Note:
*
**
***
N/A

IUS.425.0.2

Directions for use

see the lot-assigned value

user defined
optional
not applicable

Edition 2010-09-01

page 17 of 41

Chema Diagnostica - Guidelines for automatic analyzers - Ilab 600 - 650

Analyzer:

Application:

Preparation:


Storage:

Stability:

Ilab 600 - 650

LDL DIRECT FL - Code DL F080 CH
R1 - USE LIQUID RFADY TO USE REAGENT A
R2 - USE LIQUID RFADY TO USE REAGENT B
REFRIGERATE AT 2-8C
AS INDICATED IN THE LABEL

Photometric Test Parameters

Serum

Test no.
Test Name, Test Code
Sample Type
Reporting Units, Dec. Points
Reaction Cycle
Twin Analysis
Method. Type, Meas. Point
Photometric Methodology
Primary/Secondary Wav.

**
LDL-C
Serum
mg/dl, 1
Standard
OFF
End Point, 33
2 Wavelenght
600/700

Ranges and Eval. Criteria

Normal range-Male
Normal range-Female
Normal range-Other
Valid Range
Hem./Icterus/Lip. Lmt.
Reaction Slope
Absorbance Limit,
Prozone Limit
Non Linear Limit
Slope/Intercept Corr.
Qualitative Report

Serum
76 - 218
76 - 218
**
5 - 400
***
Positive
Above, 3500
N/A
N/A
1/0
OFF

Sampling Conditions
Sampling 1 Smp. Vol.

Smp./Dil. Vol.
Sampling 2 Smp.Vol.

Smp./Dil.Vol.
Sampling 3 and Sampling 4
Diluent Code
Diluent Warning Limit
First Run
Below/Above Normal Range
Panic L
Panic H
Noise
Prozone
HIGH!, ABS

3
0/0
2
0/0
***
Water
N/A
Sampling 1
***
***
Sampling 2
***
N/A
Sampling 2

Calibration Conditions
Calibration
Stability (days)
Calibrator, Conc.
R-Blank Limit (mAbs)
Cal. Reps Range (%)
Min. Cal. Resp. (mAbs)
Cal. Factor Change (%)
M-Point Curve Fit (%)
Auto R-Blank by Bottle

1 Point, Linear, 3 Reps

10
Autocal H, *
***
***
***
***
N/A
ON

Reagent Volumes
R1



R2

Code
Rgt/Dil. Vol., Stir.
Low Vol. W/ Limit
Stability (days)
Code
Rgt/Dil. Vol., Stir.
Low Vol. W/ Limit
Stability (days)

**
270/0, yes
***
60
**
90/0, yes
***
60

Note:
*
**
***
N/A

IUS.425.0.2

Directions for use

see the lot-assigned value

user defined
optional
not applicable

Edition 2010-09-01

page 18 of 41

Chema Diagnostica - Guidelines for automatic analyzers - Ilab 600 - 650

Analyzer:

Application:

Preparation:


Storage:

Stability:

Ilab 600 - 650

CHOLINESTERASE FL (DGKC) - Codes CH F096 - F245 CH
R1 - INSTALL LIQUID READY TO USE REAGENT A
R2 - INSTALL LIQUID READY TO USE REAGENT B
REFRIGERATE AT 2-8C
AS INDICATED IN THE LABEL

Photometric Test Parameters

Serum

Test no.
Test Name, Test Code
Sample Type
Reporting Units, Dec. Points
Reaction Cycle
Twin Analysis
Method. Type, Meas. Point
Photometric Methodology
Primary/Secondary Wav.

**
CHE
Serum
U/L, O
Standard
OFF
Rate, 22/27
1 Wavelenght
405

Sampling Conditions
Sampling 1 Smp. Vol.

Smp./Dil. Vol.
Sampling 2 Smp.Vol.

Smp./Dil.Vol.
Sampling 3 and Sampling 4
Diluent Code
Diluent Warning Limit
First Run
Below/Above Normal Range
Panic L
Panic H
Noise
Prozone
HIGH!, ABS

5
0/0
3
0/0
***
Water
N/A
Sampling 1
***
***
Sampling 2
***
N/A
Sampling 2

Serum

Normal range-Male
Normal range-Female
Normal range-Other
Valid Range
Hem./Icterus/Lip. Lmt.
Reaction Slope
Absorbance Limit,
Prozone Limit
Non Linear Limit
Slope/Intercept Corr.
Qualitative Report

5600 - 11200
4200 - 10800
**
50 - 25000
***
Negative
Below, 2500
N/A
40
1/0
OFF

Calib. Conditions
(option 1: K-factor)
Calibration
Stability (days)
Calibrator, Conc.
R-Blank Limit (mAbs)
Cal. Reps Range (%)
Min. Cal. Resp. (mAbs)
Cal. Factor Change (%)
M-Point Curve Fit (%)
Auto R-Blank by Bottle

Code
Rgt/Dil. Vol., Stir.
Low Vol. W/ Limit
Stability (days)
Code
Rgt/Dil. Vol., Stir.
Low Vol. W/ Limit
Stability (days)

**
250/0, yes
***
14
**
50/0, yes
***
14

Calibration
Stability (days)
Calibrator, Conc.
R-Blank Limit (mAbs)
Cal. Reps Range (%)
Min. Cal. Resp. (mAbs)
Cal. Factor Change (%)
M-Point Curve Fit (%)
Auto R-Blank by Bottle

Note:
*
**
***
N/A

IUS.425.0.2

Factor: -65.800, 3 Reps

N/A
N/A
***
N/A
N/A
N/A
N/A
ON

Calib. Conditions
(option 2: calibrator)

Reagent Volumes
R1



R2

Ranges and Eval.

Criteria

Directions for use

1 Point, Linear, 3 Reps

10
Autocal H, *
***
***
***
***
N/A
ON

see the lot-assigned value

user defined
optional
not applicable

Edition 2010-09-01

page 19 of 41

Chema Diagnostica - Guidelines for automatic analyzers - Ilab 600 - 650

Analyzer:

Application:

Preparation:


Storage:

Stability:

Ilab 600 - 650

CK-NAC FL - Codes CK F060 / F120 / F245 CH
R1 - INSTALL LIQUID READY TO USE REAGENT A
R2 - INSTALL LIQUID READY TO USE REAGENT B
REFRIGERATE AT 2-8C
AS INDICATED IN THE LABEL

Photometric Test Parameters

Serum

Test no.
Test Name, Test Code
Sample Type
Reporting Units, Dec. Points
Reaction Cycle
Twin Analysis
Method. Type, Meas. Point
Photometric Methodology
Primary/Secondary Wav.

**
CKNAC
Serum
U/L, O
Standard
OFF
Rate, 21/29
1 Wavelenght
340

Sampling Conditions
Sampling 1 Smp. Vol.

Smp./Dil. Vol.
Sampling 2 Smp.Vol.

Smp./Dil.Vol.
Sampling 3 and Sampling 4
Diluent Code
Diluent Warning Limit
First Run
Below/Above Normal Range
Panic L
Panic H
Noise
Prozone
HIGH!, ABS

12
0/0
6
0/0
***
Water
N/A
Sampling 1
***
***
Sampling 2
***
N/A
Sampling 2

Serum

Normal range-Male
Normal range-Female
Normal range-Other
Valid Range
Hem./Icterus/Lip. Lmt.
Reaction Slope
Absorbance Limit,
Prozone Limit
Non Linear Limit
Slope/Intercept Corr.
Qualitative Report

0 - 190
0 - 165
**
5 - 1600
***
Positive
Above, 2500
N/A
40
1/0
OFF

Calib. Conditions
(option 1: K-factor)
Calibration
Stability (days)
Calibrator, Conc.
R-Blank Limit (mAbs)
Cal. Reps Range (%)
Min. Cal. Resp. (mAbs)
Cal. Factor Change (%)
M-Point Curve Fit (%)
Auto R-Blank by Bottle

Code
Rgt/Dil. Vol., Stir.
Low Vol. W/ Limit
Stability (days)
Code
Rgt/Dil. Vol., Stir.
Low Vol. W/ Limit
Stability (days)

**
240/0, yes
***
14
**
60/0, yes
***
14

Calibration
Stability (days)
Calibrator, Conc.
R-Blank Limit (mAbs)
Cal. Reps Range (%)
Min. Cal. Resp. (mAbs)
Cal. Factor Change (%)
M-Point Curve Fit (%)
Auto R-Blank by Bottle

Note:
*
**
***
N/A

IUS.425.0.2

Factor: 4.127, 3 Reps

N/A
N/A
***
N/A
N/A
N/A
N/A
ON

Calib. Conditions
(option 2: calibrator)

Reagent Volumes
R1



R2

Ranges and Eval.

Criteria

Directions for use

1 Point, Linear, 3 Reps

30
Autocal H, *
***
***
***
***
N/A
ON

see the lot-assigned value

user defined
optional
not applicable

Edition 2010-09-01

page 20 of 41

Chema Diagnostica - Guidelines for automatic analyzers - Ilab 600 - 650

Analyzer:

Application:

Preparation:


Storage:

Stability:

Ilab 600 - 650

CK-MB FL - Code MB F060 / F120 CH
R1 - INSTALL LIQUID READY TO USE REAGENT A
R2 - INSTALL LIQUID READY TO USE REAGENT B
REFRIGERATE AT 2-8C
AS INDICATED IN THE LABEL

Photometric Test Parameters

Serum

Test no.
Test Name, Test Code
Sample Type
Reporting Units, Dec. Points
Reaction Cycle
Twin Analysis
Method. Type, Meas. Point
Photometric Methodology
Primary/Secondary Wav.

**
CKMB
Serum
U/L, O
Standard
OFF
Rate, 21/29
1 Wavelenght
340

Sampling Conditions
Sampling 1 Smp. Vol.

Smp./Dil. Vol.
Sampling 2 Smp.Vol.

Smp./Dil.Vol.
Sampling 3 and Sampling 4
Diluent Code
Diluent Warning Limit
First Run
Below/Above Normal Range
Panic L
Panic H
Noise
Prozone
HIGH!, ABS

12
0/0
6
0/0
***
Water
N/A
Sampling 1
***
***
Sampling 2
***
N/A
Sampling 2

Serum

Normal range-Male
Normal range-Female
Normal range-Other
Valid Range
Hem./Icterus/Lip. Lmt.
Reaction Slope
Absorbance Limit,
Prozone Limit
Non Linear Limit
Slope/Intercept Corr.
Qualitative Report

0 - 24
0 - 24
**
2 - 1600
***
Positive
Above, 3000
N/A
40
1/0
OFF

Calib. Conditions
(option 1: K-factor)
Calibration
Stability (days)
Calibrator, Conc.
R-Blank Limit (mAbs)
Cal. Reps Range (%)
Min. Cal. Resp. (mAbs)
Cal. Factor Change (%)
M-Point Curve Fit (%)
Auto R-Blank by Bottle

Code
Rgt/Dil. Vol., Stir.
Low Vol. W/ Limit
Stability (days)
Code
Rgt/Dil. Vol., Stir.
Low Vol. W/ Limit
Stability (days)

**
240/0, yes
***
14
**
60/0, yes
***
14

Calibration
Stability (days)
Calibrator, Conc.
R-Blank Limit (mAbs)
Cal. Reps Range (%)
Min. Cal. Resp. (mAbs)
Cal. Factor Change (%)
M-Point Curve Fit (%)
Auto R-Blank by Bottle

Note:
*
**
***
N/A

IUS.425.0.2

Factor: 8.254, 3 Reps

N/A
N/A
***
N/A
N/A
N/A
N/A
ON

Calib. Conditions
(option 2: calibrator)

Reagent Volumes
R1



R2

Ranges and Eval.

Criteria

Directions for use

1 Point, Linear, 3 Reps

30
MB Cal, *
***
***
***
***
N/A
ON

see the lot-assigned value

user defined
optional
not applicable

Edition 2010-09-01

page 21 of 41

Chema Diagnostica - Guidelines for automatic analyzers - Ilab 600 - 650

Analyzer:

Application:

Preparation:


Storage:

Stability:

Ilab 600 - 650

COPPER - Code CU 0100 CH
R1 - INSTALL LIQUID READY TO USE REAGENT B
R2 - INSTALL LIQUID READY TO USE REAGENT A
ROOM TEMPERATURE (Warning! The reagent A could precipitate if refrigerate)
AS INDICATED IN THE LABEL

Photometric Test Parameters

Serum

Urine

Test no.
Test Name, Test Code
Sample Type
Reporting Units, Dec. Points

**
CU
Serum
microg/dl, 0

**
CU UR
Urine
microg/dl, 0

Reaction Cycle
Twin Analysis
Method. Type, Meas. Point
Photometric Methodology
Primary/Secondary Wav.

Standard
OFF
End Point, 28
2 Wavelenght
570/660

Standard
OFF
End Point, 28
2 Wavelenght
570/660

25
0/0
10
0/0
***
Water
N/A
Sampling 1
***
***
Sampling 2
***
N/A
Sampling 2

25
0/0
10
0/0
***
Water
N/A
Sampling 1
***
***
Sampling 2
***
N/A
Sampling 2

**
188/0, yes
***
30
**
188/0, yes
***
30

**
188/0, yes
***
30
**
188/0, yes
***
30

Ranges and Eval.

Criteria

Serum

Urine

Normal range-Male
Normal range-Female
Normal range-Other
Valid Range
Hem./Icterus/Lip. Lmt.
Reaction Slope
Absorbance Limit,
Prozone Limit
Non Linear Limit
Slope/Intercept Corr.
Qualitative Report

70 - 140
80 - 155
**
1 - 500
***
Positive
Above, 4000
N/A
N/A
1/0
OFF

**
**
**
1 - 500
***
Positive
Above, 4000
N/A
N/A
1/0
OFF

1 Point, Linear,
3 Reps
3
XXX *
***
***
***
***
N/A
ON

K-Accept, Partner**,
Coeff: 5, 3 Reps
N/A
N/A
***
N/A
N/A
N/A
N/A
ON

Sampling Conditions
Sampling 1 Smp. Vol.

Smp./Dil. Vol.
Sampling 2 Smp.Vol.

Smp./Dil.Vol.
Sampling 3 and Sampling 4
Diluent Code
Diluent Warning Limit
First Run
Below/Above Normal Range
Panic L
Panic H
Noise
Prozone
HIGH!, ABS

Calibration Conditions
Calibration

Stability (days)
Calibrator, Conc.
R-Blank Limit (mAbs)
Cal. Reps Range (%)
Min. Cal. Resp. (mAbs)
Cal. Factor Change (%)
M-Point Curve Fit (%)
Auto R-Blank by Bottle

Reagent Volumes
R1



R2

Code
Rgt/Dil. Vol., Stir.
Low Vol. W/ Limit
Stability (days)
Code
Rgt/Dil. Vol., Stir.
Low Vol. W/ Limit
Stability (days)

Note:
*
**
***
N/A

IUS.425.0.2

Directions for use

see the lot-assigned value

user defined
optional
not applicable

Edition 2010-09-01

page 22 of 41

Chema Diagnostica - Guidelines for automatic analyzers - Ilab 600 - 650

Analyzer:

Application:

Preparation:


Storage:

Stability:

Ilab 600 - 650

CREATININE - Code CR 0500 / 1000 / 1500 CH
R1 - INSTALL LIQUID READY TO USE REAGENT B
R2 - INSTALL LIQUID READY TO USE REAGENT A
ROOM TEMPERATURE OR REFRIGERATE (2-30C)
AS INDICATED IN THE LABEL

Photometric Test Parameters

Serum

Urine

Test no.
Test Name, Test Code
Sample Type
Reporting Units, Dec. Points

**
CREA
Serum
mg/dl, 2

**
CREA UR
Urine
mg/dl, 1

Reaction Cycle
Twin Analysis
Method. Type, Meas. Point
Photometric Methodology
Primary/Secondary Wav.

Standard
OFF
End Point, 19/23
2 Wavelenght
510/570

Standard
OFF
End Point, 19/23
2 Wavelenght
510/570

20
0/0
10
0/0
***
Water
N/A
Sampling 1
***
***
Sampling 2
***
N/A
Sampling 2

20
8/395
20
4/395
***
Water
N/A
Sampling 1
***
***
Sampling 2
***
N/A
Sampling 2

**
150/0, yes
***
10
**
150/0, yes
***
10

**
150/0, yes
***
10
**
150/0, yes
***
10

Ranges and Eval.

Criteria

Serum

Urine

Normal range-Male
Normal range-Female
Normal range-Other
Valid Range
Hem./Icterus/Lip. Lmt.
Reaction Slope
Absorbance Limit,
Prozone Limit
Non Linear Limit
Slope/Intercept Corr.
Qualitative Report

0.60 - 1.20
0.50 - 1.00
**
0.10 - 20.0
***
Positive
Above, 3500
N/A
N/A
1/0
OFF

**
**
**
2 - 800
***
Positive
Above, 3500
N/A
N/A
1/0
OFF

1 Point, Linear,
3 Reps
10
Autocal H, *
***
***
***
***
N/A
ON

K-Accept, Partner**,
Coeff: 50, 3 Reps
N/A
N/A
***
N/A
N/A
N/A
N/A
ON

Sampling Conditions
Sampling 1 Smp. Vol.

Smp./Dil. Vol.
Sampling 2 Smp.Vol.

Smp./Dil.Vol.
Sampling 3 and Sampling 4
Diluent Code
Diluent Warning Limit
First Run
Below/Above Normal Range
Panic L
Panic H
Noise
Prozone
HIGH!, ABS

Calibration Conditions
Calibration

Stability (days)
Calibrator, Conc.
R-Blank Limit (mAbs)
Cal. Reps Range (%)
Min. Cal. Resp. (mAbs)
Cal. Factor Change (%)
M-Point Curve Fit (%)
Auto R-Blank by Bottle

Reagent Volumes
R1



R2

Code
Rgt/Dil. Vol., Stir.
Low Vol. W/ Limit
Stability (days)
Code
Rgt/Dil. Vol., Stir.
Low Vol. W/ Limit
Stability (days)

Note:
*
**
***
N/A

IUS.425.0.2

Directions for use

see the lot-assigned value

user defined
optional
not applicable

Edition 2010-09-01

page 23 of 41

Chema Diagnostica - Guidelines for automatic analyzers - Ilab 600 - 650

Analyzer:

Application:

Preparation:


Storage:

Stability:

Ilab 600 - 650

GAMMA-GT FL - Codes GT F080 / F245 / F400 / F600 CH
R1 - INSTALL LIQUID READY TO USE REAGENT A
R2 - INSTALL LIQUID READY TO USE REAGENT B
REFRIGERATE AT 2-8C
AS INDICATED IN THE LABEL

Photometric Test Parameters

Serum

Test no.
Test Name, Test Code
Sample Type
Reporting Units, Dec. Points
Reaction Cycle
Twin Analysis
Method. Type, Meas. Point
Photometric Methodology
Primary/Secondary Wav.

**
GGT
Serum
U/L, O
Standard
OFF
Rate, 21/27
1 Wavelenght
405

Sampling Conditions
Sampling 1 Smp. Vol.

Smp./Dil. Vol.
Sampling 2 Smp.Vol.

Smp./Dil.Vol.
Sampling 3 and Sampling 4
Diluent Code
Diluent Warning Limit
First Run
Below/Above Normal Range
Panic L
Panic H
Noise
Prozone
HIGH!, ABS

30
0/0
15
0/0
***
Water
N/A
Sampling 1
***
***
Sampling 2
***
N/A
Sampling 2

Serum

Normal range-Male
Normal range-Female
Normal range-Other
Valid Range
Hem./Icterus/Lip. Lmt.
Reaction Slope
Absorbance Limit,
Prozone Limit
Non Linear Limit
Slope/Intercept Corr.
Qualitative Report

10 - 47
7 - 30
**
2 - 700
***
Positive
Above, 4000
N/A
40
1/0
OFF

Calib. Conditions
(option 1: K-factor)
Calibration
Stability (days)
Calibrator, Conc.
R-Blank Limit (mAbs)
Cal. Reps Range (%)
Min. Cal. Resp. (mAbs)
Cal. Factor Change (%)
M-Point Curve Fit (%)
Auto R-Blank by Bottle

Code
Rgt/Dil. Vol., Stir.
Low Vol. W/ Limit
Stability (days)
Code
Rgt/Dil. Vol., Stir.
Low Vol. W/ Limit
Stability (days)

**
240/0, yes
***
14
**
60/0, yes
***
14

Calibration
Stability (days)
Calibrator, Conc.
R-Blank Limit (mAbs)
Cal. Reps Range (%)
Min. Cal. Resp. (mAbs)
Cal. Factor Change (%)
M-Point Curve Fit (%)
Auto R-Blank by Bottle

Note:
*
**
***
N/A

IUS.425.0.2

Factor: 1.158, 3 Reps

N/A
N/A
***
N/A
N/A
N/A
N/A
ON

Calib. Conditions
(option 2: calibrator)

Reagent Volumes
R1



R2

Ranges and Eval.

Criteria

Directions for use

1 Point, Linear, 3 Reps

14
Autocal H, *
***
***
***
***
N/A
ON

see the lot-assigned value

user defined
optional
not applicable

Edition 2010-09-01

page 24 of 41

Chema Diagnostica - Guidelines for automatic analyzers - Ilab 600 - 650

Analyzer:

Ilab 600 - 650

Application:
Preparation:
Storage:
Stability:

GLUCOSE FL - Code GL F400 / 100F / 150F CH

R1 - LIQUID READY TO USE SINGLE REAGENT
REFRIGERATE AT 2-8C
AS INDICATED IN THE LABEL

Photometric Test Parameters

Serum

Urine

Test no.
Test Name, Test Code
Sample Type
Reporting Units, Dec. Points

**
GLUC
Serum
mg/dl, 0

**
GLUC UR
Urine
mg/dl, 0

Reaction Cycle
Twin Analysis
Method. Type, Meas. Point
Photometric Methodology
Primary/Secondary Wav.

Standard
OFF
End Point, 33
2 Wavelenght
510/660

Standard
OFF
End Point, 33
2 Wavelenght
510/660

3
0/0
2
0/0
***
Water
N/A
Sampling 1
***
***
Sampling 2
***
N/A
Sampling 2

3
0/0
2
0/0
***
Water
N/A
Sampling 1
***
***
Sampling 2
***
N/A
Sampling 2

**
300/0, yes
***
14
N/A
N/A
N/A
N/A

**
300/0, yes
***
14
N/A
N/A
N/A
N/A

Ranges and Eval.

Criteria

Serum

Urine

Normal range-Male
Normal range-Female
Normal range-Other
Valid Range
Hem./Icterus/Lip. Lmt.
Reaction Slope
Absorbance Limit,
Prozone Limit
Non Linear Limit
Slope/Intercept Corr.
Qualitative Report

60 - 110
60 - 110
**
10 - 500
***
Positive
Above, 3500
N/A
N/A
1/0
OFF

**
**
**
10 - 500
***
Positive
Above, 3500
N/A
N/A
1/0
OFF

1 Point, Linear,
3 Reps
10
Autocal H, *
***
***
***
***
N/A
ON

K-Accept, Partner**,
Coeff: 1, 3 Reps
N/A
N/A
***
N/A
N/A
N/A
N/A
ON

Sampling Conditions
Sampling 1 Smp. Vol.

Smp./Dil. Vol.
Sampling 2 Smp.Vol.

Smp./Dil.Vol.
Sampling 3 and Sampling 4
Diluent Code
Diluent Warning Limit
First Run
Below/Above Normal Range
Panic L
Panic H
Noise
Prozone
HIGH!, ABS

Calibration Conditions
Calibration

Stability (days)
Calibrator, Conc.
R-Blank Limit (mAbs)
Cal. Reps Range (%)
Min. Cal. Resp. (mAbs)
Cal. Factor Change (%)
M-Point Curve Fit (%)
Auto R-Blank by Bottle

Reagent Volumes
R1



R2

Code
Rgt/Dil. Vol., Stir.
Low Vol. W/ Limit
Stability (days)
Code
Rgt/Dil. Vol., Stir.
Low Vol. W/ Limit
Stability (days)

Note:
*
**
***
N/A

IUS.425.0.2

Directions for use

see the lot-assigned value

user defined
optional
not applicable

Edition 2010-09-01

page 25 of 41

Chema Diagnostica - Guidelines for automatic analyzers - Ilab 600 - 650

Analyzer:

Application:

Preparation:


Storage:

Stability:

Ilab 600 - 650

GLUCOSE UV FL - Code GL F601 CH
R1 - INSTALL LIQUID READY TO USE REAGENT A
R2 - INSTALL LIQUID READY TO USE REAGENT B
REFRIGERATE AT 2-8C
AS INDICATED IN THE LABEL

Photometric Test Parameters

Serum

Urine

Test no.
Test Name, Test Code
Sample Type
Reporting Units, Dec. Points

**
GLUC
Serum
mg/dl, 0

**
GLUC UR
Urine
mg/dl, 0

Reaction Cycle
Twin Analysis
Method. Type, Meas. Point
Photometric Methodology
Primary/Secondary Wav.

Standard
OFF
End Point, 33
2 Wavelenght
340/660

Standard
OFF
End Point, 33
2 Wavelenght
340/660

3
0/0
2
0/0
***
Water
N/A
Sampling 1
***
***
Sampling 2
***
N/A
Sampling 2

3
0/0
2
0/0
***
Water
N/A
Sampling 1
***
***
Sampling 2
***
N/A
Sampling 2

**
240/0, yes
***
14
**
60/0, yes
***
14

**
240/0, yes
***
14
**
60/0, yes
***
14

Ranges and Eval.

Criteria

Serum

Urine

Normal range-Male
Normal range-Female
Normal range-Other
Valid Range
Hem./Icterus/Lip. Lmt.
Reaction Slope
Absorbance Limit,
Prozone Limit
Non Linear Limit
Slope/Intercept Corr.
Qualitative Report

60 - 110
60 - 110
**
10 - 500
***
Positive
Above, 3500
N/A
N/A
1/0
OFF

**
**
**
10 - 700
***
Positive
Above, 3500
N/A
N/A
1/0
OFF

1 Point, Linear,
3 Reps
10
Autocal H, *
***
***
***
***
N/A
ON

K-Accept, Partner**,
Coeff: 1, 3 Reps
N/A
N/A
***
N/A
N/A
N/A
N/A
ON

Sampling Conditions
Sampling 1 Smp. Vol.

Smp./Dil. Vol.
Sampling 2 Smp.Vol.

Smp./Dil.Vol.
Sampling 3 and Sampling 4
Diluent Code
Diluent Warning Limit
First Run
Below/Above Normal Range
Panic L
Panic H
Noise
Prozone
HIGH!, ABS

Calibration Conditions
Calibration

Stability (days)
Calibrator, Conc.
R-Blank Limit (mAbs)
Cal. Reps Range (%)
Min. Cal. Resp. (mAbs)
Cal. Factor Change (%)
M-Point Curve Fit (%)
Auto R-Blank by Bottle

Reagent Volumes
R1



R2

Code
Rgt/Dil. Vol., Stir.
Low Vol. W/ Limit
Stability (days)
Code
Rgt/Dil. Vol., Stir.
Low Vol. W/ Limit
Stability (days)

Note:
*
**
***
N/A

IUS.425.0.2

Directions for use

see the lot-assigned value

user defined
optional
not applicable

Edition 2010-09-01

page 26 of 41

Chema Diagnostica - Guidelines for automatic analyzers - Ilab 600 - 650

Analyzer:

Application:

Preparation:


Storage:

Stability:

Ilab 600 - 650

GOT/AST FL - Codes GO F080 / F245 / F400 / F600 CH
R1 - INSTALL LIQUID READY TO USE REAGENT A
R2 - INSTALL LIQUID READY TO USE REAGENT B
REFRIGERATE AT 2-8C
AS INDICATED IN THE LABEL

Photometric Test Parameters

Serum

Test no.
Test Name, Test Code
Sample Type
Reporting Units, Dec. Points
Reaction Cycle
Twin Analysis
Method. Type, Meas. Point
Photometric Methodology
Primary/Secondary Wav.

**
GOT
Serum
U/L, O
Standard
OFF
Rate, 21/27
1 Wavelenght
340

Sampling Conditions
Sampling 1 Smp. Vol.

Smp./Dil. Vol.
Sampling 2 Smp.Vol.

Smp./Dil.Vol.
Sampling 3 and Sampling 4
Diluent Code
Diluent Warning Limit
First Run
Below/Above Normal Range
Panic L
Panic H
Noise
Prozone
HIGH!, ABS

30
0/0
15
0/0
***
Water
N/A
Sampling 1
***
***
Sampling 2
***
N/A
Sampling 2

Serum

Normal range-Male
Normal range-Female
Normal range-Other
Valid Range
Hem./Icterus/Lip. Lmt.
Reaction Slope
Absorbance Limit,
Prozone Limit
Non Linear Limit
Slope/Intercept Corr.
Qualitative Report

0 - 40
0 - 31
**
2 - 400
***
Negative
Below, 2000
N/A
40
1/0
OFF

Calib. Conditions
(option 1: K-factor)
Calibration
Stability (days)
Calibrator, Conc.
R-Blank Limit (mAbs)
Cal. Reps Range (%)
Min. Cal. Resp. (mAbs)
Cal. Factor Change (%)
M-Point Curve Fit (%)
Auto R-Blank by Bottle

Code
Rgt/Dil. Vol., Stir.
Low Vol. W/ Limit
Stability (days)
Code
Rgt/Dil. Vol., Stir.
Low Vol. W/ Limit
Stability (days)

**
240/0, yes
***
14
**
60/0, yes
***
14

Calibration
Stability (days)
Calibrator, Conc.
R-Blank Limit (mAbs)
Cal. Reps Range (%)
Min. Cal. Resp. (mAbs)
Cal. Factor Change (%)
M-Point Curve Fit (%)
Auto R-Blank by Bottle

Note:
*
**
***
N/A

IUS.425.0.2

Factor: -1.746, 3 Reps

N/A
N/A
***
N/A
N/A
N/A
N/A
ON

Calib. Conditions
(option 2: calibrator)

Reagent Volumes
R1



R2

Ranges and Eval.

Criteria

Directions for use

1 Point, Linear, 3 Reps

14
Autocal H, *
***
***
***
***
N/A
ON

see the lot-assigned value

user defined
optional
not applicable

Edition 2010-09-01

page 27 of 41

Chema Diagnostica - Guidelines for automatic analyzers - Ilab 600 - 650

Analyzer:

Application:

Preparation:


Storage:

Stability:

Ilab 600 - 650

GPT/ALT FL - Codes GP F080 / F245 / F400 / F600 CH
R1 - INSTALL LIQUID READY TO USE REAGENT A
R2 - INSTALL LIQUID READY TO USE REAGENT B
REFRIGERATE AT 2-8C
AS INDICATED IN THE LABEL

Photometric Test Parameters

Serum

Test no.
Test Name, Test Code
Sample Type
Reporting Units, Dec. Points
Reaction Cycle
Twin Analysis
Method. Type, Meas. Point
Photometric Methodology
Primary/Secondary Wav.

**
GPT
Serum
U/L, O
Standard
OFF
Rate, 21/27
1 Wavelenght
340

Sampling Conditions
Sampling 1 Smp. Vol.

Smp./Dil. Vol.
Sampling 2 Smp.Vol.

Smp./Dil.Vol.
Sampling 3 and Sampling 4
Diluent Code
Diluent Warning Limit
First Run
Below/Above Normal Range
Panic L
Panic H
Noise
Prozone
HIGH!, ABS

30
0/0
15
0/0
***
Water
N/A
Sampling 1
***
***
Sampling 2
***
N/A
Sampling 2

Serum

Normal range-Male
Normal range-Female
Normal range-Other
Valid Range
Hem./Icterus/Lip. Lmt.
Reaction Slope
Absorbance Limit,
Prozone Limit
Non Linear Limit
Slope/Intercept Corr.
Qualitative Report

0 - 42
0 - 32
**
2 - 400
***
Negative
Below, 2000
N/A
40
1/0
OFF

Calib. Conditions
(option 1: K-factor)
Calibration
Stability (days)
Calibrator, Conc.
R-Blank Limit (mAbs)
Cal. Reps Range (%)
Min. Cal. Resp. (mAbs)
Cal. Factor Change (%)
M-Point Curve Fit (%)
Auto R-Blank by Bottle

Code
Rgt/Dil. Vol., Stir.
Low Vol. W/ Limit
Stability (days)
Code
Rgt/Dil. Vol., Stir.
Low Vol. W/ Limit
Stability (days)

**
240/0, yes
***
14
**
60/0, yes
***
14

Calibration
Stability (days)
Calibrator, Conc.
R-Blank Limit (mAbs)
Cal. Reps Range (%)
Min. Cal. Resp. (mAbs)
Cal. Factor Change (%)
M-Point Curve Fit (%)
Auto R-Blank by Bottle

Note:
*
**
***
N/A

IUS.425.0.2

Factor: -1.746, 3 Reps

N/A
N/A
***
N/A
N/A
N/A
N/A
ON

Calib. Conditions
(option 2: calibrator)

Reagent Volumes
R1



R2

Ranges and Eval.

Criteria

Directions for use

1 Point, Linear, 3 Reps

14
Autocal H, *
***
***
***
***
N/A
ON

see the lot-assigned value

user defined
optional
not applicable

Edition 2010-09-01

page 28 of 41

Chema Diagnostica - Guidelines for automatic analyzers - Ilab 600 - 650

Analyzer:

Ilab 600 - 650

Application:
Preparation:

Storage:
Stability:

IRON FZ - Code FE F245 / F400 CH

R1 - USE LIQUID RFADY TO USE REAGENT A
R2 - INSTALL LIQUID READY TO USE REAGENT B (preparation: read insert sheet)
REFRIGERATE AT 2-8C
AS INDICATED IN THE LABEL

Photometric Test Parameters

Serum

Test no.
Test Name, Test Code
Sample Type
Reporting Units, Dec. Points
Reaction Cycle
Twin Analysis
Method. Type, Meas. Point
Photometric Methodology
Primary/Secondary Wav.

**
IRON
Serum
microg/dl, 1
Standard
OFF
End Point, 16/33
2 Wavelenght
600/700

Ranges and Eval. Criteria

Normal range-Male
Normal range-Female
Normal range-Other
Valid Range
Hem./Icterus/Lip. Lmt.
Reaction Slope
Absorbance Limit,
Prozone Limit
Non Linear Limit
Slope/Intercept Corr.
Qualitative Report

Serum
59 - 158
37 - 145
**
5 - 1000
***
Positive
Above, 3500
N/A
N/A
1/0
OFF

Sampling Conditions
Sampling 1 Smp. Vol.

Smp./Dil. Vol.
Sampling 2 Smp.Vol.

Smp./Dil.Vol.
Sampling 3 and Sampling 4
Diluent Code
Diluent Warning Limit
First Run
Below/Above Normal Range
Panic L
Panic H
Noise
Prozone
HIGH!, ABS

40
0/0
20
0/0
***
Water
N/A
Sampling 1
***
***
Sampling 2
***
N/A
Sampling 2

Calibration Conditions
Calibration
Stability (days)
Calibrator, Conc.
R-Blank Limit (mAbs)
Cal. Reps Range (%)
Min. Cal. Resp. (mAbs)
Cal. Factor Change (%)
M-Point Curve Fit (%)
Auto R-Blank by Bottle

1 Point, Linear, 3 Reps

10
Autocal H, *
***
***
***
***
N/A
ON

Reagent Volumes
R1



R2

Code
Rgt/Dil. Vol., Stir.
Low Vol. W/ Limit
Stability (days)
Code
Rgt/Dil. Vol., Stir.
Low Vol. W/ Limit
Stability (days)

**
240/0, yes
***
15
**
60/0, yes
***
15

Note:
*
**
***
N/A

IUS.425.0.2

Directions for use

see the lot-assigned value

user defined
optional
not applicable

Edition 2010-09-01

page 29 of 41

Chema Diagnostica - Guidelines for automatic analyzers - Ilab 600 - 650

Analyzer:

Application:

Preparation:


Storage:

Stability:

Ilab 600 - 650

LDH FL - Codes LD F060 / F120 / F245 CH
R1 - INSTALL LIQUID READY TO USE REAGENT A
R2 - INSTALL LIQUID READY TO USE REAGENT B
REFRIGERATE AT 2-8C
AS INDICATED IN THE LABEL

Photometric Test Parameters

Serum

Test no.
Test Name, Test Code
Sample Type
Reporting Units, Dec. Points
Reaction Cycle
Twin Analysis
Method. Type, Meas. Point
Photometric Methodology
Primary/Secondary Wav.

**
LDH
Serum
U/L, O
Standard
OFF
Rate, 21/27
1 Wavelenght
340

Sampling Conditions
Sampling 1 Smp. Vol.

Smp./Dil. Vol.
Sampling 2 Smp.Vol.

Smp./Dil.Vol.
Sampling 3 and Sampling 4
Diluent Code
Diluent Warning Limit
First Run
Below/Above Normal Range
Panic L
Panic H
Noise
Prozone
HIGH!, ABS

3
0/0
2
0/0
***
Water
N/A
Sampling 1
***
***
Sampling 2
***
N/A
Sampling 2

Serum

Normal range-Male
Normal range-Female
Normal range-Other
Valid Range
Hem./Icterus/Lip. Lmt.
Reaction Slope
Absorbance Limit,
Prozone Limit
Non Linear Limit
Slope/Intercept Corr.
Qualitative Report

225 - 450
225 - 450
**
10 - 4000
***
Negative
Below, 300
N/A
40
1/0
OFF

Calib. Conditions
(option 1: K-factor)
Calibration
Stability (days)
Calibrator, Conc.
R-Blank Limit (mAbs)
Cal. Reps Range (%)
Min. Cal. Resp. (mAbs)
Cal. Factor Change (%)
M-Point Curve Fit (%)
Auto R-Blank by Bottle

Code
Rgt/Dil. Vol., Stir.
Low Vol. W/ Limit
Stability (days)
Code
Rgt/Dil. Vol., Stir.
Low Vol. W/ Limit
Stability (days)

**
240/0, yes
***
14
**
60/0, yes
***
14

Calibration
Stability (days)
Calibrator, Conc.
R-Blank Limit (mAbs)
Cal. Reps Range (%)
Min. Cal. Resp. (mAbs)
Cal. Factor Change (%)
M-Point Curve Fit (%)
Auto R-Blank by Bottle

Note:
*
**
***
N/A

IUS.425.0.2

Factor: -16.030, 3 Reps

N/A
N/A
***
N/A
N/A
N/A
N/A
ON

Calib. Conditions
(option 2: calibrator)

Reagent Volumes
R1



R2

Ranges and Eval.

Criteria

Directions for use

1 Point, Linear, 3 Reps

14
Autocal H, *
***
***
***
***
N/A
ON

see the lot-assigned value

user defined
optional
not applicable

Edition 2010-09-01

page 30 of 41

Chema Diagnostica - Guidelines for automatic analyzers - Ilab 600 - 650

Analyzer:

Application:

Preparation:


Storage:

Stability:

Ilab 600 - 650

LIPASE FL - Code LP F060 CH
R1 - INSTALL LIQUID READY TO USE REAGENT A
R2 - INSTALL LIQUID READY TO USE REAGENT B
REFRIGERATE AT 2-8C
AS INDICATED IN THE LABEL

Photometric Test Parameters

Serum

Test no.
Test Name, Test Code
Sample Type
Reporting Units, Dec. Points
Reaction Cycle
Twin Analysis
Method. Type, Meas. Point
Photometric Methodology
Primary/Secondary Wav.

**
LIP
Serum
U/L, O
Standard
OFF
Rate, 21/31
1 Wavelenght
570

Sampling Conditions
Sampling 1 Smp. Vol.

Smp./Dil. Vol.
Sampling 2 Smp.Vol.

Smp./Dil.Vol.
Sampling 3 and Sampling 4
Diluent Code
Diluent Warning Limit
First Run
Below/Above Normal Range
Panic L
Panic H
Noise
Prozone
HIGH!, ABS

3
0/0
2
0/0
***
Water
N/A
Sampling 1
***
***
Sampling 2
***
N/A
Sampling 2

Ranges and Eval.

Criteria

Serum

Normal range-Male
Normal range-Female
Normal range-Other
Valid Range
Hem./Icterus/Lip. Lmt.
Reaction Slope
Absorbance Limit,
Prozone Limit
Non Linear Limit
Slope/Intercept Corr.
Qualitative Report

0 - 63
0 - 63
**
1 - 250
***
Positive
Above, 4000
N/A
40
1/0
OFF

Calib. Conditions
Calibration
Stability (days)
Calibrator, Conc.
R-Blank Limit (mAbs)
Cal. Reps Range (%)
Min. Cal. Resp. (mAbs)
Cal. Factor Change (%)
M-Point Curve Fit (%)
Auto R-Blank by Bottle

1 Point, Linear, 3 Reps

14
LIP Calib, *
***
***
***
***
N/A
ON

Reagent Volumes
R1



R2

Code
Rgt/Dil. Vol., Stir.
Low Vol. W/ Limit
Stability (days)
Code
Rgt/Dil. Vol., Stir.
Low Vol. W/ Limit
Stability (days)

**
240/0, yes
***
14
**
60/0, yes
***
14

Note:
*
**
***
N/A

IUS.425.0.2

Directions for use

see the lot-assigned value

user defined
optional
not applicable

Edition 2010-09-01

page 31 of 41

Chema Diagnostica - Guidelines for automatic analyzers - Ilab 600 - 650

Analyzer:

Application:

Preparation:


Storage:

Stability:

Ilab 600 - 650

MAGNESIUM - Code MG 0200 / 0500 CH
R1 - INSTALL LIQUID READY TO USE REAGENT B
R2 - INSTALL LIQUID READY TO USE REAGENT A
ROOM TEMPERATURE OR REFRIGERATE (2-30C)
AS INDICATED IN THE LABEL

Photometric Test Parameters

Serum

Urine

Test no.
Test Name, Test Code
Sample Type
Reporting Units, Dec. Points

**
MG
Serum
mEq/l, 2

**
MG UR
Urine
mEq/l, 1

Reaction Cycle
Twin Analysis
Method. Type, Meas. Point
Photometric Methodology
Primary/Secondary Wav.

Standard
OFF
End Point, 28
2 Wavelenght
510/660

Standard
OFF
End Point, 28
2 Wavelenght
510/660

4
0/0
2
0/0
***
Water
N/A
Sampling 1
***
***
Sampling 2
***
N/A
Sampling 2

4
50/50
4
10/90
***
Water
N/A
Sampling 1
***
***
Sampling 2
***
N/A
Sampling 2

**
200/0, yes
***
10
**
200/0, yes
***
10

**
200/0, yes
***
10
**
200/0, yes
***
10

Ranges and Eval.

Criteria

Serum

Urine

Normal range-Male
Normal range-Female
Normal range-Other
Valid Range
Hem./Icterus/Lip. Lmt.
Reaction Slope
Absorbance Limit,
Prozone Limit
Non Linear Limit
Slope/Intercept Corr.
Qualitative Report

1.30 - 2.10
1.30 - 2.10
**
0.10 - 8.00
***
Positive
Above, 4000
N/A
N/A
1/0
OFF

**
**
**
0.1 - 15.0
***
Positive
Above, 4000
N/A
N/A
1/0
OFF

1 Point, Linear,
3 Reps
3
Autocal H, *
***
***
***
***
N/A
ON

K-Accept, Partner**,
Coeff: 2, 3 Reps
N/A
N/A
***
N/A
N/A
N/A
N/A
ON

Sampling Conditions
Sampling 1 Smp. Vol.

Smp./Dil. Vol.
Sampling 2 Smp.Vol.

Smp./Dil.Vol.
Sampling 3 and Sampling 4
Diluent Code
Diluent Warning Limit
First Run
Below/Above Normal Range
Panic L
Panic H
Noise
Prozone
HIGH!, ABS

Calibration Conditions
Calibration

Stability (days)
Calibrator, Conc.
R-Blank Limit (mAbs)
Cal. Reps Range (%)
Min. Cal. Resp. (mAbs)
Cal. Factor Change (%)
M-Point Curve Fit (%)
Auto R-Blank by Bottle

Reagent Volumes
R1



R2

Code
Rgt/Dil. Vol., Stir.
Low Vol. W/ Limit
Stability (days)
Code
Rgt/Dil. Vol., Stir.
Low Vol. W/ Limit
Stability (days)

Note:
*
**
***
N/A

IUS.425.0.2

Directions for use

see the lot-assigned value

user defined
optional
not applicable

Edition 2010-09-01

page 32 of 41

Chema Diagnostica - Guidelines for automatic analyzers - Ilab 600 - 650

Analyzer:

Ilab 600 - 650

Application:
Preparation:
Storage:
Stability:

MAGNESIUM XL - Codes MX 0300 / 0500 CH

R1 - LIQUID READY TO USE SINGLE REAGENT
REFRIGERATE (2-8C)
AS INDICATED IN THE LABEL

Photometric Test Parameters

Serum

Urine

Test no.
Test Name, Test Code
Sample Type
Reporting Units, Dec. Points

Reaction Cycle
Twin Analysis
Method. Type, Meas. Point
Photometric Methodology
Primary/Secondary Wav.

**
MX
Serum
mEq/l, 2

**
MX UR
Urine
mEq/l, 1

Standard
OFF
End Point, 30
2 Wavelenght
546/660

Standard
OFF
End Point, 30
2 Wavelenght
546/660

3
0/0
3
0/0
***
Water
N/A
Sampling 1
***
***
Sampling 2
***
N/A
Sampling 2

3
20/80
3
10/90
***
Water
N/A
Sampling 1
***
***
Sampling 2
***
N/A
Sampling 2

**
300/0, yes
***
30
N/A
N/A
N/A
N/A

**
300/0, yes
***
30
N/A
N/A
N/A
N/A

Ranges and Eval.

Criteria

Serum

Urine

Normal range-Male
Normal range-Female
Normal range-Other
Valid Range
Hem./Icterus/Lip. Lmt.
Reaction Slope
Absorbance Limit,
Prozone Limit
Non Linear Limit
Slope/Intercept Corr.
Qualitative Report

1.30 - 2.10
1.30 - 2.10
**
0.30 - 6.00
***
Positive
Above, 4000
N/A
N/A
1/0
OFF

**
**
**
0.3 - 15.0
***
Positive
Above, 4000
N/A
N/A
1/0
OFF

1 Point, Linear,
3 Reps
3
Autocal H, *
***
***
***
***
N/A
ON

K-Accept, Partner**,
Coeff: 2, 3 Reps
N/A
N/A
***
N/A
N/A
N/A
N/A
ON

Sampling Conditions
Sampling 1 Smp. Vol.

Smp./Dil. Vol.
Sampling 2 Smp.Vol.

Smp./Dil.Vol.
Sampling 3 and Sampling 4
Diluent Code
Diluent Warning Limit
First Run
Below/Above Normal Range
Panic L
Panic H
Noise
Prozone
HIGH!, ABS

Calibration Conditions
Calibration

Stability (days)
Calibrator, Conc.
R-Blank Limit (mAbs)
Cal. Reps Range (%)
Min. Cal. Resp. (mAbs)
Cal. Factor Change (%)
M-Point Curve Fit (%)
Auto R-Blank by Bottle

Reagent Volumes
R1



R2

Code
Rgt/Dil. Vol., Stir.
Low Vol. W/ Limit
Stability (days)
Code
Rgt/Dil. Vol., Stir.
Low Vol. W/ Limit
Stability (days)

Note:
*
**
***
N/A

IUS.425.0.2

Directions for use

see the lot-assigned value

user defined
optional
not applicable

Edition 2010-09-01

page 33 of 41

Chema Diagnostica - Guidelines for automatic analyzers - Ilab 600 - 650

Analyzer:

Ilab 600 - 650

Application:
Preparation:
Storage:
Stability:

PHOSPHORUS - Code PH 0100 / 0500 CH

R1 - LIQUID READY TO USE SINGLE REAGENT
REFRIGERATE AT 2-8C
AS INDICATED IN THE LABEL

Photometric Test Parameters

Serum

Urine

Test no.
Test Name, Test Code
Sample Type
Reporting Units, Dec. Points

**
PHOS
Serum
mg/dl, 1

**
PHOS UR
Urine
mg/dl, 0

Reaction Cycle
Twin Analysis
Method. Type, Meas. Point
Photometric Methodology
Primary/Secondary Wav.

Standard
OFF
End Point, 33
2 Wavelenght
340/375

Standard
OFF
End Point, 33
2 Wavelenght
340/375

3
0/0
2
0/0
***
Water
N/A
Sampling 1
***
***
Sampling 2
***
N/A
Sampling 2

3
10/90
3
5/95
***
Water
N/A
Sampling 1
***
***
Sampling 2
***
N/A
Sampling 2

**
300/0, yes
***
30
N/A
N/A
N/A
N/A

**
300/0, yes
***
30
N/A
N/A
N/A
N/A

Ranges and Eval.

Criteria

Serum

Urine

Normal range-Male
Normal range-Female
Normal range-Other
Valid Range
Hem./Icterus/Lip. Lmt.
Reaction Slope
Absorbance Limit,
Prozone Limit
Non Linear Limit
Slope/Intercept Corr.
Qualitative Report

3.0 - 4.5
3.0 - 4.5
**
1.0 - 15.0
***
Positive
Above, 4000
N/A
N/A
1/0
OFF

**
**
**
2 - 120
***
Positive
Above, 4000
N/A
N/A
1/0
OFF

1 Point, Linear,
3 Reps
10
Autocal H, *
***
***
***
***
N/A
ON

K-Accept, Partner**,
Coeff: 10, 3 Reps
N/A
N/A
***
N/A
N/A
N/A
N/A
ON

Sampling Conditions
Sampling 1 Smp. Vol.

Smp./Dil. Vol.
Sampling 2 Smp.Vol.

Smp./Dil.Vol.
Sampling 3 and Sampling 4
Diluent Code
Diluent Warning Limit
First Run
Below/Above Normal Range
Panic L
Panic H
Noise
Prozone
HIGH!, ABS

Calibration Conditions
Calibration

Stability (days)
Calibrator, Conc.
R-Blank Limit (mAbs)
Cal. Reps Range (%)
Min. Cal. Resp. (mAbs)
Cal. Factor Change (%)
M-Point Curve Fit (%)
Auto R-Blank by Bottle

Reagent Volumes
R1



R2

Code
Rgt/Dil. Vol., Stir.
Low Vol. W/ Limit
Stability (days)
Code
Rgt/Dil. Vol., Stir.
Low Vol. W/ Limit
Stability (days)

Note:
*
**
***
N/A

IUS.425.0.2

Directions for use

see the lot-assigned value

user defined
optional
not applicable

Edition 2010-09-01

page 34 of 41

Chema Diagnostica - Guidelines for automatic analyzers - Ilab 600 - 650

Analyzer:

Ilab 600 - 650

Application:
Preparation:
Storage:
Stability:

PROTEINS HS - Code HS 0100 / 0500 CH

R1 - LIQUID READY TO USE SINGLE REAGENT
ROOM TEMPERATURE OR REFRIGERATE (2-30C)
AS INDICATED IN THE LABEL

Photometric Test Parameters

Urine

Test no.
Test Name, Test Code
Sample Type
Reporting Units, Dec. Points
Reaction Cycle
Twin Analysis
Method. Type, Meas. Point
Photometric Methodology
Primary/Secondary Wav.

**
HS
Urine
mg/dl, 0
Standard
OFF
End Point, 33
2 Wavelenght
600/700

Ranges and Eval. Criteria

Normal range-Male
Normal range-Female
Normal range-Other
Valid Range
Hem./Icterus/Lip. Lmt.
Reaction Slope
Absorbance Limit,
Prozone Limit
Non Linear Limit
Slope/Intercept Corr.
Qualitative Report

Urine
28 - 141
28 - 141
**
10 - 500
***
Positive
Above, 4000
N/A
N/A
1/0
OFF

Sampling Conditions
Sampling 1 Smp. Vol.

Smp./Dil. Vol.
Sampling 2 Smp.Vol.

Smp./Dil.Vol.
Sampling 3 and Sampling 4
Diluent Code
Diluent Warning Limit
First Run
Below/Above Normal Range
Panic L
Panic H
Noise
Prozone
HIGH!, ABS

2
0/0
2
0/0
***
Water
N/A
Sampling 1
***
***
Sampling 2
***
N/A
Sampling 2

Calibration Conditions
Calibration
Stability (days)
Calibrator, Conc.
R-Blank Limit (mAbs)
Cal. Reps Range (%)
Min. Cal. Resp. (mAbs)
Cal. Factor Change (%)
M-Point Curve Fit (%)
Auto R-Blank by Bottle

1 Point, Linear, 3 Reps

10
Standard, *
***
***
***
***
N/A
ON

Reagent Volumes
R1



R2

Code
Rgt/Dil. Vol., Stir.
Low Vol. W/ Limit
Stability (days)
Code
Rgt/Dil. Vol., Stir.
Low Vol. W/ Limit
Stability (days)

**
400/0, yes
***
30
N/A
N/A
N/A
N/A

Note:
*
**
***
N/A

IUS.425.0.2

Directions for use

see the lot-assigned value

user defined
optional
not applicable

Edition 2010-09-01

page 35 of 41

Chema Diagnostica - Guidelines for automatic analyzers - Ilab 600 - 650

Analyzer:

Ilab 600 - 650

Application:
Preparation:
Storage:
Stability:

TOTAL PROTEINS - Codes TP 0100 / 0500 / 1000 / 1500 CH

R1 - LIQUID READY TO USE SINGLE REAGENT
ROOM TEMPERATURE OR REFRIGERATE (2-30C)
AS INDICATED IN THE LABEL

Photometric Test Parameters

Serum

Test no.
Test Name, Test Code
Sample Type
Reporting Units, Dec. Points
Reaction Cycle
Twin Analysis
Method. Type, Meas. Point
Photometric Methodology
Primary/Secondary Wav.

**
TP
Serum
g/dl, 1
Standard
OFF
End Point, 33
2 Wavelenght
546/700

Ranges and Eval. Criteria

Normal range-Male
Normal range-Female
Normal range-Other
Valid Range
Hem./Icterus/Lip. Lmt.
Reaction Slope
Absorbance Limit,
Prozone Limit
Non Linear Limit
Slope/Intercept Corr.
Qualitative Report

Serum
6.3 - 8.4
6.3 - 8.4
**
0.5 - 12.0
***
Positive
Above, 4000
N/A
N/A
1/0
OFF

Sampling Conditions
Sampling 1 Smp. Vol.

Smp./Dil. Vol.
Sampling 2 Smp.Vol.

Smp./Dil.Vol.
Sampling 3 and Sampling 4
Diluent Code
Diluent Warning Limit
First Run
Below/Above Normal Range
Panic L
Panic H
Noise
Prozone
HIGH!, ABS

3
0/0
2
0/0
***
Water
N/A
Sampling 1
***
***
Sampling 2
***
N/A
Sampling 2

Calibration Conditions
Calibration
Stability (days)
Calibrator, Conc.
R-Blank Limit (mAbs)
Cal. Reps Range (%)
Min. Cal. Resp. (mAbs)
Cal. Factor Change (%)
M-Point Curve Fit (%)
Auto R-Blank by Bottle

1 Point, Linear, 3 Reps

10
Autocal H, *
***
***
***
***
N/A
ON

Reagent Volumes
R1



R2

Code
Rgt/Dil. Vol., Stir.
Low Vol. W/ Limit
Stability (days)
Code
Rgt/Dil. Vol., Stir.
Low Vol. W/ Limit
Stability (days)

**
300/0, yes
***
30
N/A
N/A
N/A
N/A

Note:
*
**
***
N/A

IUS.425.0.2

Directions for use

see the lot-assigned value

user defined
optional
not applicable

Edition 2010-09-01

page 36 of 41

Chema Diagnostica - Guidelines for automatic analyzers - Ilab 600 - 650

Analyzer:

Ilab 600 - 650

Application:
Preparation:
Storage:
Stability:

TRIGLYCERIDES FL - Code TR F100 / F400 / 100F / 150F CH

R1 - LIQUID READY TO USE SINGLE REAGENT
REFRIGERATE AT 2-8C
AS INDICATED IN THE LABEL

Photometric Test Parameters

Serum

Test no.
Test Name, Test Code
Sample Type
Reporting Units, Dec. Points
Reaction Cycle
Twin Analysis
Method. Type, Meas. Point
Photometric Methodology
Primary/Secondary Wav.

**
TRIG
Serum
mg/dl, 0
Standard
OFF
End Point, 33
2 Wavelenght
510/660

Ranges and Eval. Criteria

Normal range-Male
Normal range-Female
Normal range-Other
Valid Range
Hem./Icterus/Lip. Lmt.
Reaction Slope
Absorbance Limit,
Prozone Limit
Non Linear Limit
Slope/Intercept Corr.
Qualitative Report

Serum
10 - 190
10 - 190
**
2 - 1000
***
Positive
Above, 4000
N/A
N/A
1/0
OFF

Sampling Conditions
Sampling 1 Smp. Vol.

Smp./Dil. Vol.
Sampling 2 Smp.Vol.

Smp./Dil.Vol.
Sampling 3 and Sampling 4
Diluent Code
Diluent Warning Limit
First Run
Below/Above Normal Range
Panic L
Panic H
Noise
Prozone
HIGH!, ABS

3
0/0
2
0/0
***
Water
N/A
Sampling 1
***
***
Sampling 2
***
N/A
Sampling 2

Calibration Conditions
Calibration
Stability (days)
Calibrator, Conc.
R-Blank Limit (mAbs)
Cal. Reps Range (%)
Min. Cal. Resp. (mAbs)
Cal. Factor Change (%)
M-Point Curve Fit (%)
Auto R-Blank by Bottle

1 Point, Linear, 3 Reps

20
Autocal H, *
***
***
***
***
N/A
ON

Reagent Volumes
R1



R2

Code
Rgt/Dil. Vol., Stir.
Low Vol. W/ Limit
Stability (days)
Code
Rgt/Dil. Vol., Stir.
Low Vol. W/ Limit
Stability (days)

**
300/0, yes
***
60
N/A
N/A
N/A
N/A

Note:
*
**
***
N/A

IUS.425.0.2

Directions for use

see the lot-assigned value

user defined
optional
not applicable

Edition 2010-09-01

page 37 of 41

Chema Diagnostica - Guidelines for automatic analyzers - Ilab 600 - 650

Analyzer:

Application:

Preparation:


Storage:

Stability:

Ilab 600 - 650

UREA UV FL - Codes AZ F080 / F245 / F400 / F600 CH
R1 - INSTALL LIQUID READY TO USE REAGENT A
R2 - INSTALL LIQUID READY TO USE REAGENT B
REFRIGERATE AT 2-8C
AS INDICATED IN THE LABEL

Photometric Test Parameters

Serum

Urine

Test no.
Test Name, Test Code
Sample Type
Reporting Units, Dec. Points

**
UREA
Serum
mg/dl, 0

**
UREA UR
Urine
mg/dl, 0

Reaction Cycle
Twin Analysis
Method. Type, Meas. Point
Photometric Methodology
Primary/Secondary Wav.

Standard
OFF
End Point, 19/22
1 Wavelenght
340

Standard
OFF
End Point, 19/22
1 Wavelenght
340

3
0/0
10
0/0
***
Water
N/A
Sampling 1
***
***
Sampling 2
***
N/A
Sampling 2

3
8/395
2
4/395
***
Water
N/A
Sampling 1
***
***
Sampling 2
***
N/A
Sampling 2

**
240/0, yes
***
14
**
60/0, yes
***
14

**
240/0, yes
***
14
**
60/0, yes
***
14

Ranges and Eval.

Criteria

Serum

Urine

Normal range-Male
Normal range-Female
Normal range-Other
Valid Range
Hem./Icterus/Lip. Lmt.
Reaction Slope
Absorbance Limit,
Prozone Limit
Non Linear Limit
Slope/Intercept Corr.
Qualitative Report

10 - 50
10 - 50
**
2 - 300
***
Negative
Below, 250
N/A
N/A
1/0
OFF

**
**
**
2 - 10000
***
Negative
Below, 250
N/A
N/A
1/0
OFF

1 Point, Linear,
3 Reps
10
Autocal H, *
***
***
***
***
N/A
ON

K-Accept, Partner**,
Coeff: 50, 3 Reps
N/A
N/A
***
N/A
N/A
N/A
N/A
ON

Sampling Conditions
Sampling 1 Smp. Vol.

Smp./Dil. Vol.
Sampling 2 Smp.Vol.

Smp./Dil.Vol.
Sampling 3 and Sampling 4
Diluent Code
Diluent Warning Limit
First Run
Below/Above Normal Range
Panic L
Panic H
Noise
Prozone
HIGH!, ABS

Calibration Conditions
Calibration

Stability (days)
Calibrator, Conc.
R-Blank Limit (mAbs)
Cal. Reps Range (%)
Min. Cal. Resp. (mAbs)
Cal. Factor Change (%)
M-Point Curve Fit (%)
Auto R-Blank by Bottle

Reagent Volumes
R1



R2

Code
Rgt/Dil. Vol., Stir.
Low Vol. W/ Limit
Stability (days)
Code
Rgt/Dil. Vol., Stir.
Low Vol. W/ Limit
Stability (days)

Note:
*
**
***
N/A

IUS.425.0.2

Directions for use

see the lot-assigned value

user defined
optional
not applicable

Edition 2010-09-01

page 38 of 41

Chema Diagnostica - Guidelines for automatic analyzers - Ilab 600 - 650

Analyzer:

Application:

Preparation:


Storage:

Stability:

Ilab 600 - 650

URIC ACID AOX FL - Codes AX F100 / F250 / F600 CH
R1 - INSTALL LIQUID READY TO USE REAGENT A
R2 - INSTALL LIQUID READY TO USE REAGENT B
REFRIGERATE AT 2-8C
AS INDICATED IN THE LABEL

Photometric Test Parameters

Serum

Urine

Test no.
Test Name, Test Code
Sample Type
Reporting Units, Dec. Points

Reaction Cycle
Twin Analysis
Method. Type, Meas. Point
Photometric Methodology
Primary/Secondary Wav.

**
AOX
Serum
mg/dl, 1

**
AOX UR
Urine
mg/dl, 0

Standard
OFF
End Point, 28
2 Wavelenght
546/660

Standard
OFF
End Point, 28
2 Wavelenght
546/660

12
0/0
6
10/90
***
Water
N/A
Sampling 1
***
***
Sampling 2
***
N/A
Sampling 2

12
20/80
12
10/90
***
Water
N/A
Sampling 1
***
***
Sampling 2
***
N/A
Sampling 2

**
240/0, yes
***
30
**
60/0, yes
***
30

**
240/0, yes
***
30
**
60/0, yes
***
30

Sampling Conditions
Sampling 1 Smp. Vol.

Smp./Dil. Vol.
Sampling 2 Smp.Vol.

Smp./Dil.Vol.
Sampling 3 and Sampling 4
Diluent Code
Diluent Warning Limit
First Run
Below/Above Normal Range
Panic L
Panic H
Noise
Prozone
HIGH!, ABS

Ranges and Eval.

Criteria

Serum

Urine

Normal range-Male
Normal range-Female
Normal range-Other
Valid Range
Hem./Icterus/Lip. Lmt.
Reaction Slope
Absorbance Limit,
Prozone Limit
Non Linear Limit
Slope/Intercept Corr.
Qualitative Report

3.5 - 7.2
2.6 - 6.0
**
1.0 - 35.0
***
Positive
Above, 4000
N/A
N/A
1/0
OFF

**
**
**
2 - 120
***
Positive
Above, 4000
N/A
N/A
1/0
OFF

1 Point, Linear,
3 Reps
10
Autocal H, *
***
***
***
***
N/A
ON

K-Accept, Partner**,
Coeff: 5, 3 Reps
N/A
N/A
***
N/A
N/A
N/A
N/A
ON

Calibration Conditions
Calibration

Stability (days)
Calibrator, Conc.
R-Blank Limit (mAbs)
Cal. Reps Range (%)
Min. Cal. Resp. (mAbs)
Cal. Factor Change (%)
M-Point Curve Fit (%)
Auto R-Blank by Bottle

Reagent Volumes
R1



R2

Code
Rgt/Dil. Vol., Stir.
Low Vol. W/ Limit
Stability (days)
Code
Rgt/Dil. Vol., Stir.
Low Vol. W/ Limit
Stability (days)

Note:
*
**
***
N/A

IUS.425.0.2

Directions for use

see the lot-assigned value

user defined
optional
not applicable

Edition 2010-09-01

page 39 of 41

Chema Diagnostica - Guidelines for automatic analyzers - Ilab 600 - 650

Analyzer:

Ilab 600 - 650

Application:
Preparation:
Storage:
Stability:

URIC ACID T FL - Code AU F402 CH

R1 - MIX REAGENT A + REAGENT B AS INDICATED IN INSERT SHEET
REFRIGERATE AT 2-8C
90 DAYS

Photometric Test Parameters

Serum

Urine

Test no.
Test Name, Test Code
Sample Type
Reporting Units, Dec. Points

**
URIC
Serum
mg/dl, 1

**
URIC UR
Urine
mg/dl, 0

Reaction Cycle
Twin Analysis
Method. Type, Meas. Point
Photometric Methodology
Primary/Secondary Wav.

Standard
OFF
End Point, 28
2 Wavelenght
546/660

Standard
OFF
End Point, 28
2 Wavelenght
546/660

12
0/0
6
10/90
***
Water
N/A
Sampling 1
***
***
Sampling 2
***
N/A
Sampling 2

12
20/80
12
10/90
***
Water
N/A
Sampling 1
***
***
Sampling 2
***
N/A
Sampling 2

**
300/0, yes
***
30
N/A
N/A
N/A
N/A

**
300/0, yes
***
30
N/A
N/A
N/A
N/A

Ranges and Eval.

Criteria

Serum

Urine

Normal range-Male
Normal range-Female
Normal range-Other
Valid Range
Hem./Icterus/Lip. Lmt.
Reaction Slope
Absorbance Limit,
Prozone Limit
Non Linear Limit
Slope/Intercept Corr.
Qualitative Report

3.5 - 7.0
2.4 - 5.7
**
1.0 - 25.0
***
Positive
Above, 4000
N/A
N/A
1/0
OFF

**
**
**
2 - 120
***
Positive
Above, 4000
N/A
N/A
1/0
OFF

1 Point, Linear,
3 Reps
10
Autocal H, *
***
***
***
***
N/A
ON

K-Accept, Partner**,
Coeff: 5, 3 Reps
N/A
N/A
***
N/A
N/A
N/A
N/A
ON

Sampling Conditions
Sampling 1 Smp. Vol.

Smp./Dil. Vol.
Sampling 2 Smp.Vol.

Smp./Dil.Vol.
Sampling 3 and Sampling 4
Diluent Code
Diluent Warning Limit
First Run
Below/Above Normal Range
Panic L
Panic H
Noise
Prozone
HIGH!, ABS

Calibration Conditions
Calibration

Stability (days)
Calibrator, Conc.
R-Blank Limit (mAbs)
Cal. Reps Range (%)
Min. Cal. Resp. (mAbs)
Cal. Factor Change (%)
M-Point Curve Fit (%)
Auto R-Blank by Bottle

Reagent Volumes
R1



R2

Code
Rgt/Dil. Vol., Stir.
Low Vol. W/ Limit
Stability (days)
Code
Rgt/Dil. Vol., Stir.
Low Vol. W/ Limit
Stability (days)

Note:
*
**
***
N/A

IUS.425.0.2

Directions for use

see the lot-assigned value

user defined
optional
not applicable

Edition 2010-09-01

page 40 of 41

Chema Diagnostica - Guidelines for automatic analyzers - Ilab 600 - 650

Analyzer:

Application:

Preparation:


Storage:

Stability:

Ilab 600 - 650

ZINC - Code ZN 0125 CH
R1 - INSTALL LIQUID READY TO USE REAGENT A
R2 - INSTALL LIQUID READY TO USE REAGENT B
REFRIGERATE AT 2-8C
AS INDICATED IN THE LABEL

Photometric Test Parameters

Serum

Urine

Test no.
Test Name, Test Code
Sample Type
Reporting Units, Dec. Points

**
ZN
Serum
microg/dl, 0

**
ZN UR
Urine
microg/dl, 0

Reaction Cycle
Twin Analysis
Method. Type, Meas. Point
Photometric Methodology
Primary/Secondary Wav.

Standard
OFF
End Point, 28
2 Wavelenght
570/660

Standard
OFF
End Point, 28
2 Wavelenght
570/660

15
0/0
5
0/0
***
Water
N/A
Sampling 1
***
***
Sampling 2
***
N/A
Sampling 2

15
0/0
5
0/0
***
Water
N/A
Sampling 1
***
***
Sampling 2
***
N/A
Sampling 2

**
240/0, yes
***
30
**
240/0, yes
***
30

**
240/0, yes
***
30
**
240/0, yes
***
30

Ranges and Eval.

Criteria

Serum

Urine

Normal range-Male
Normal range-Female
Normal range-Other
Valid Range
Hem./Icterus/Lip. Lmt.
Reaction Slope
Absorbance Limit,
Prozone Limit
Non Linear Limit
Slope/Intercept Corr.
Qualitative Report

70 - 150
70 - 150
**
1 - 1000
***
Positive
Above, 4000
N/A
N/A
1/0
OFF

**
**
**
1 - 1000
***
Positive
Above, 4000
N/A
N/A
1/0
OFF

1 Point, Linear,
3 Reps
3
XXX, *
***
***
***
***
N/A
ON

K-Accept, Partner**,
Coeff: 5, 3 Reps
N/A
N/A
***
N/A
N/A
N/A
N/A
ON

Sampling Conditions
Sampling 1 Smp. Vol.

Smp./Dil. Vol.
Sampling 2 Smp.Vol.

Smp./Dil.Vol.
Sampling 3 and Sampling 4
Diluent Code
Diluent Warning Limit
First Run
Below/Above Normal Range
Panic L
Panic H
Noise
Prozone
HIGH!, ABS

Calibration Conditions
Calibration

Stability (days)
Calibrator, Conc.
R-Blank Limit (mAbs)
Cal. Reps Range (%)
Min. Cal. Resp. (mAbs)
Cal. Factor Change (%)
M-Point Curve Fit (%)
Auto R-Blank by Bottle

Reagent Volumes
R1



R2

Code
Rgt/Dil. Vol., Stir.
Low Vol. W/ Limit
Stability (days)
Code
Rgt/Dil. Vol., Stir.
Low Vol. W/ Limit
Stability (days)

Note:
*
**
***
N/A

IUS.425.0.2

Directions for use

see the lot-assigned value

user defined
optional
not applicable

Edition 2010-09-01

page 41 of 41