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 | [email protected]
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 2-8°C
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 (2-30°C)
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 2-8°C
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 2-8°C
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 2-8°C
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 é 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 2-8°C
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 2-8°C
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 (2-30°C)
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 2-8°C
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 2-8°C
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 (2-30°C)
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 2-8°C
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 2-8°C
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 2-8°C
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 2-8°C
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 2-8°C
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 2-8°C
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 2-8°C
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 (2-30°C)
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 2-8°C
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 2-8°C
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 2-8°C
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 2-8°C
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 2-8°C
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 2-8°C
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 2-8°C
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 2-8°C
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 (2-30°C)
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 (2-8°C)
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 2-8°C
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 (2-30°C)
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 (2-30°C)
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 2-8°C
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 2-8°C
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 2-8°C
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 2-8°C
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 2-8°C
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