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K Number
K991576
Device Name
ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM
Manufacturer
BAYER CORP.
Date Cleared
1999-06-30

(55 days)

Product Code
CIXCDQCEOCFOCFRCGACGSCGXCICCIGCITCJKJFYJIYKHMKNKLBS
Regulation Number
862.1035
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ADVIA 1650 Chemistry System is an automated, clinical chemistry analyzer that can run tests on human serum, plasma, or urine in random access, batch, and STAT modes at a throughput rate of 1200 photometric tests per hour and 450 electrolyte tests per hour. The photometric analyzer performs clinical chemistry and immuno-turbidimetric methods. The electrylyte portion of the analyzer measures the sodium, and chloride concentrations in serum, plasma or urine samples based on a potentiometric procedure that uses ion-selective electrodes. The ADVIA 1650 is intended for use in conjunction with certain reagents to measure a variety of analytes contained in human fluids.
Device Description
The ADVIA 1650 Chemistry System is an automated, clinical chemistry analyzer that can run tests on human serum, plasma, or urine in random access, batch, and STAT modes at a throughput rate of 1200 photometric tests per hour and 450 electrolyte tests per hour. The photometric analyzer performs clinical chemistry and immuno-turbidimetric methods. The electrylyte portion of the analyzer measures the sodium, and chloride concentrations in human serum, plasma or urine samples based on a potentiometric procedure that uses ion-selective electrodes.
More Information

K991576

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No
The description focuses on standard automated chemistry analysis techniques (photometry, potentiometry, ion-selective electrodes) and performance metrics (CV, regression, correlation) without mentioning any AI/ML components or capabilities.

No
The device is described as an automated clinical chemistry analyzer that measures analytes in human fluids, which is for diagnostic purposes, not therapeutic intervention.

Yes
The device is described as a "clinical chemistry analyzer" that "can run tests on human serum, plasma, or urine" to "measure a variety of analytes contained in human fluids." Measuring analytes in human fluids for diagnosis falls under the definition of a diagnostic device.

No

The device description clearly outlines hardware components such as a photometric analyzer, electrolyte portion, and ion-selective electrodes, indicating it is a physical system, not software-only.

Yes, based on the provided information, the ADVIA 1650 Chemistry System is an IVD (In Vitro Diagnostic) device.

Here's why:

  • Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is an "automated, clinical chemistry analyzer that can run tests on human serum, plasma, or urine". It also mentions it's "intended for use in conjunction with certain reagents to measure a variety of analytes contained in human fluids." This clearly indicates the device is used to perform tests on biological samples taken from the human body (in vitro) to provide information about a person's health.
  • Device Description: The "Device Description" further reinforces this by detailing how the analyzer measures specific substances (analytes like sodium and chloride) in human serum, plasma, or urine.
  • Performance Studies: The "Summary of Performance Studies" describes studies evaluating the device's performance in measuring analyte concentrations in samples, which is a core function of an IVD.
  • Predicate Devices: The list of "Predicate Device(s)" includes other clinical chemistry analyzers, which are also typically classified as IVDs.

The definition of an IVD generally involves devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. The ADVIA 1650 fits this description perfectly.

N/A

Intended Use / Indications for Use

The ADVIA 1650 Chemistry System is an automated, clinical chemistry analyzer that can run tests on human serum, plasma, or urine in random access, batch, and STAT modes at a throughput rate of 1200 photometric tests per hour and 450 electrolyte tests per hour. The photometric analyzer performs clinical chemistry and immuno-turbidimetric methods. The electrylyte portion of the analyzer measures the sodium, and chloride concentrations in serum, plasma or urine samples based on a potentiometric procedure that uses ion-selective electrodes. The ADVIA 1650 is intended for use in conjunction with certain reagents to measure a variety of analytes contained in human fluids.

Product codes (comma separated list FDA assigned to the subject device)

CIX, CJK, KHM, CIT, CIC, CGX, JFY, CGS, CIG, CFR, CGA, LBS, CDQ, CEO, JIY, CFO, KNK

Device Description

The ADVIA 1650 Chemistry System is an automated, clinical chemistry analyzer that can run tests on human serum, plasma, or urine in random access, batch, and STAT modes at a throughput rate of 1200 photometric tests per hour and 450 electrolyte tests per hour. The photometric analyzer performs clinical chemistry and immuno-turbidimetric methods. The electrylyte portion of the analyzer measures the sodium, and chloride concentrations in serum, plasma or urine samples based on a potentiometric procedure that uses ion-selective electrodes.

Mentions image processing

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Mentions AI, DNN, or ML

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Input Imaging Modality

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Anatomical Site

Not Found

Indicated Patient Age Range

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Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

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Description of the test set, sample size, data source, and annotation protocol

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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The document provides performance comparisons for 21 clinical methods, comparing the Advia 1650 to similar predicate devices. For each method (Albumin, Alkaline Phosphatase AMP, Amylase, Aspartate Aminotransferase, Calcium, Chloride, Creatine Phosphokinase, Creatinine, Creatinine-Enzymatic, Direct Bilirubin, Glucose-Hexokinase, Glucose-Oxidase, High Density Lipoprotein, Inorganic Phosphorus, Iron, Magnesium, Potassium, Sodium, Total Bilirubin, Uric Acid, Urea Nitrogen), the following information is provided:

  • Imprecision: Total CV (%) for various levels/concentrations of the analyte in different specimen types (serum, plasma, urine) for both the Advia 1650 and predicate devices. Sample sizes for imprecision studies are not explicitly stated, but are implied by the levels.
  • Correlation: Linear regression analysis (Y=ADVIA 1650, X=comparison system) with regression equation, N (sample size), Syx (standard error of the estimate), R (correlation coefficient), and Sample Range for different specimen types and sites.
  • Interfering Substances: Effect (in concentration and %) of common interfering substances (Bilirubin, Hemoglobin, Lipids/Triglycerides) on analyte concentration.
  • Analytical Range: The detectable range of analyte concentration for the Advia 1650 for different specimen types.
  • Expected Values: Reference ranges for analyte concentration generally provided for serum, plasma, and/or urine, and sometimes further stratified by gender or age.

Key results from correlation studies (R-values) generally show strong correlation (R > 0.9) between the Advia 1650 and predicate devices for the measured analytes. Imprecision (Total CV%) values are also provided at different analyte levels, generally demonstrating low variability. Interference studies assess the impact of common substances on measurement accuracy.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K991576,

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 862.1035 Albumin test system.

(a)
Identification. An albumin test system is a device intended to measure the albumin concentration in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.(b)
Classification. Class II.

0

K991576

SUMMARY OF SAFETY AND EFFECTIVENESS

This section contains performance comparisons for 21 clinical methods. For each method, Advia 1650 was compared to a similar device (or devices) that was granted clearance of substantial equivalence. The table below lists the predicate devices and part numbers.

ADVIA 1650SpecimenPredicate DevicePredicate Device
MethodReagent Part #TypeNameReagent Part #
AlbuminB01-4121-01SerumTechnicon DAX®T01-1337-B3
Alkaline Phosphatase - AMPB01-4134-01SerumTechnicon DAX®T01-1814
AmylaseB01-4136-01SerumBeckman Synchron CX®442775
UrineBeckman Synchron CX7®442775
Aspartate AminotransferaseB01-4139-01SerumTechnicon DAX®T01-1750
CalciumB01-4145-01SerumTechnicon DAX®T01-1476
UrineDuPont DimensionDF23A
ChlorideB01-4171-01UrineBeckman Synchron CX3®450214, 472095
SerumTechnicon DAX®T152-17
SerumBeckman Synchron CX7®450214, 472095
UrineBeckman Synchron CX3/7®450214, 472095
Creatine KinaseB01-4137-01SerumTechnicon DAX®T01-1882
SerumBeckman Synchron CX7®443794
Creatinine, JaffeB01-4126-01SerumTechnicon DAX®T01-1927
UrineHitachi®1040847
Creatinine, EnzymaticB01-4127-01SerumTechnicon DAX®T01-1927
Bilirubin, DirectB01-4123-01SerumTechnicon DAX®T01-1565
SerumHitachi®1109774
Glucose - HexokinaseB01-4129-01SerumTechnicon DAX®T11-1832
UrineHitachi®1447521
Glucose - OxidaseB01-4130-01SerumTechnicon DAX®T01-1492-56
UrineBeckman Synchron CX3/7®443355
HDL CholesterolB01-4125-01SerumBoehringer Mannheim on RA-XT543004
Inorganic PhosphorusB01-4144-01SerumTechnicon DAX®T01-1303
SerumBeckman Synchron CX7®465145
UrineCobas Fara®44031
IronB01-4147-01SerumTechnicon DAX®150-26E, 150-26F
SerumSigma RA1000565-1, 565-3
MagnesiumB01-4148-01SerumTechnicon DAX®T01-2878
Serum/UrineHitachi®1273582
PotassiumB01-4171-01SerumTechnicon DAX®T01-3161
UrineBeckman Synchron CX3®443325, 443315
SodiumB01-4171-01SerumTechnicon DAX®T01-3161
UrineBeckman Synchron CX3®450124, 472095
Bilirubin, TotalB01-4122-01SerumTechnicon DAX®T01-1963
Uric AcidB01-4131-01SerumTechnicon DAX®T01-2577
UrineBeckman Synchron CX7®442785
UrineCobas Fara®828475
Urea NitrogenB01-4132-01SerumTechnicon DAX®T01-1823
UrineBeckman Synchron CX3/7®443359

Gabriel J. Muraca, Jr.
Gabriel J. Muraca, Jr.

Manager, Regulatory Affairs Bayer Corporation 511 Benedict Ave. Tarrytown, NY 10591-5097

4/29/99

Date

1

1. ALB

SUMMARY OF SAFETY AND EFFECTIVENESS

Albumin Method for the Bayer ADVIA 1650 (g/dL)

Intended Use

This in vitro diagnostic assay is intended to measure albumin concentration in human serum and plasma on the ADVIA® 1650 Chemistry System. Such measurements are used in the diagnosis and treatment of chronic inflammatory diseases, collagen diseases, and liver and kidney disorders.

Imprecision

Advia 1650Technicon
Specimen typeLevelTotal CV (%)Level
Serum2.12.42.2
Serum3.41.83.4
4.8

DAX Total CV (%) 3.3 2.5 2.0

Correlation (Y=ADVIA 1650, X=comparison system)

Specimen type: SiteComparison System (X)NRegression EquationSyxRSample Range
Serum: MSKDAX156Y=0.86X+0.550.190.9691.6-5.3
Plasma(y), Serum(x)ADVIA 165058Y=0.96X+0.290.050.9784.5-5.7

Interfering Substances

| Interfering | Interfering
Sub. Conc.
(mg/dL) | Analyte
conc. | Effect | |
|---------------|--------------------------------------|------------------|--------|-----|
| Substance | | | conc. | % |
| Bilirubin | 25 | 4.2 | 0.0 | 0.0 |
| Hemoglobin | 500 | 3.7 | 0.3 | 8.1 |
| Lipids (Trig) | 500 | 4.1 | 0.3 | 7.3 |

Analytical Range

1 to 6 g/dL

Expected Values

3.4 - 4.8 g/dL

2

2. ALP-AMP

SUMMARY OF SAFETY AND EFFECTIVENESS

Alkaline Phosphatase AMP Method for the Bayer ADVIA 1650 (U/L)

Intended Use

This in vitro diagnostic assay is intended to measure alkaline phosphatase activity in human serum and plasma on an ADVIA® 1650 Chemistry System. Such measurements are used mainly in the diagnosis and treatment of hepatobiliary and bone disease.

Imprecision

Specimen typeLevelTotal CV (%)
Serum693.9
Serum1303.1
Technicon DAX
LevelTotal CV (%)
792.5
1862.2
5711.9

Correlation (Y=ADVIA 1650, X=comparison system)

| Specimen type: Site | Comparison
System (X) | N | Regression
Equation | Syx | R | Sample
Range |
|---------------------|--------------------------|----|------------------------|------|-------|-----------------|
| Serum: TRYTN | DAX | 43 | $Y=1.03X-2.1$ | 3.12 | 0.999 | 22-346 |
| Plasma(y), Serum(x) | ADVIA 1650 | 54 | $Y=1.06X+1.42$ | 5.37 | 0.972 | 33-149 |

Interfering Substances

| Interfering
Substance | Interfering
Sub. Conc.
(mg/dL) | Analyte
conc. | Effect | |
|--------------------------|--------------------------------------|------------------|--------|------|
| | | | conc. | % |
| Bilirubin | 25 | 69.3 | 1.7 | 2.5 |
| Hemoglobin | 500 | 100.3 | -5.6 | -5.6 |
| Lipids (Trig) | 500 | 71.0 | 1.3 | 1.8 |

Analytical Range

0-1100 U/L

Expected Values

25 to 100 U/L

3

3. AMY

SUMMARY OF SAFETY AND EFFECTIVENESS

Amylase Method for the Bayer ADVIA 1650 (U/L)

Intended Use

This in vitro diagnostic assay is intended to measure amylase activity in human serum, plasma and urine on an ADVIA® 1650 Chemistry System. Such measurements are used primarily in the diagnosis and monitoring of acute pancreatitis (inflammation of the pancreas).

Imprecision

Advia 1650Beckman CX7=Serum, Urine
Specimen
typeLevelTotal
CV (%)LevelTotal CV (%)
Serum601.285.75.3
Serum2421.32405.3
Serum3221.23205.3
Urine7927.28005.3

Correlation (Y=ADVIA 1650, X=comparison system)

Specimen type: SiteComparison System (X)NRegression EquationSyxRSample Range
Serum: MSKCX4102Y=0.72X+1.913.50.9986-549
Plasma(y), Serum(x)ADVIA 165053Y=1.08X+1.463.90.98518-110
Urine: MSKCX782Y=0.75X+0.7413.40.9932-667

Bias expected in serum and urine correlation when run against Beckman instrument due to the different substrates used in each instrument.

Interfering Substances

| Interfering
Substance | Interfering
Sub. Conc.
(mg/dL) | Analyte
conc. | Effect | |
|--------------------------|--------------------------------------|------------------|--------|------|
| Bilirubin | 25 | 68.3 | -1.6 | -2.3 |
| Hemoglobin | 500 | 174.3 | -2.3 | -1.3 |
| Lipids (Trig) | 500 | 66.3 | 1.4 | 2.1 |

Analytical Range

Serum/Plasma:0 to 1500 U/L (from reagent stability study)
Urine0 to 1500 U/L (from reagent stability study)
Serum:20-104 U/L
Urine:1-17 U/h (timed)

4

4. AST

SUMMARY OF SAFETY AND EFFECTIVENESS

Aspartate Aminotransferase Method for the Bayer ADVIA 1650 (U/L)

Intended Use

This in vitro diagnostic assay is intended to measure aspartate aminotransferase activity in human serum and plasma on an ADVIA® 1650 Chemistry System. Such measurements are used mainly to determine the progress and prognosis of patients with myocardial infarction and the diagnosis and monitoring of liver disease.

Imprecision

Advia 1650
Specimen typeLevelTotal CV (%)
Serum323.9
Serum1461.7

Correlation (Y=ADVIA 1650, X=comparison system)

| Specimen type: Site | Comparison
System (X) | N | Regression
Equation | Syx | R | Sample
Range |
|---------------------|--------------------------|-----|------------------------|------|-------|-----------------|
| Serum: BERLIN | DAX | 111 | $Y=0.99X-6.3$ | 3.63 | 0.999 | 9.8-607.2 |
| Plasma(y), Serum(x) | ADVIA 1650 | 54 | $Y=1.00X-2.9$ | 3.01 | 0.954 | 16-85 |

Interfering Substances

| Interfering
Substance | Interfering
Sub. Conc.
(mg/dL) | Analyte
conc. | Effect | |
|--------------------------|--------------------------------------|------------------|--------|-------|
| Bilirubin | 25 | 31.0 | -3.7 | -11.9 |
| Hemoglobin | 500 | 74.7 | 18.6 | 24.9 |
| Lipids (Trig) | 500 | 29.7 | -4.4 | -14.8 |

Hemolyzed samples should not be used due to effect by RBC.

Analytical Range

0-1000 U/L (from reagent stability study)

Expected Values

M: 15 - 40 U/L. F: 13 - 35 U/L.

5

5. Ca

SUMMARY OF SAFETY AND EFFECTIVENESS

Calcium Method for the Bayer ADVIA 1650 (mg/dL)

Intended Use

This in vitro diagnostic assay is intended to measure calcium concentration in human serum, plasma and urine on an ADVIA® 1650 Chemistry System. Such measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease, and tetany.

Imprecision

Advia 1650Technicon DAX = SerumDupont Dimension=Urine
Specimen
typeLevelTotal
CV (%)LevelTotal CV (%)LevelBetween Day CV (%)
Serum5.92.77.72.38.80.6
Serum10.82.910.31.614.52.6
Serum12.03.512.51.5
Urine6.22.4
Urine21.22.5

Correlation (Y=ADVIA 1650, X=comparison system)

Specimen typeComparison System (X)NRegression EquationSyxRSample Range
Serum - ARIDAX100$Y=0.99X + 0.13$0.2230.9717.0 - 13.2
Plasma(y), Serum(x)ADVIA 165059$Y=0.94X + 0.82$0.0940.9639.0 - 10.8
Urine - ARIDimension32$Y=1.2X - 2.25$0.1650.9993.7 - 14.5
Urine - MSKCX363$Y=1.07X + 0.03$0.5580.9882.1 - 14.7

Interfering Substances

| Interfering
Substance | Interfering
Sub. Conc.
(mg/dL) | Analyte
conc. | Effect
conc. | % |
|--------------------------|--------------------------------------|------------------|-----------------|-----|
| Bilirubin | 25 | 8.0 | 0.0 | 0.0 |
| Hemoglobin | 500 | 8.8 | 0.2 | 2.3 |
| Lipids (Trig) | 500 | 8.0 | 0.3 | 3.8 |

Analytical Range

Serum/Plasma:1 to 15 mg/dL
Urine:1 to 15 mg/dL
Serum/Plasma:8.6 to 10.0 mg/dL
Urine:100 to 300 mg/d

6

SUMMARY OF SAFETY AND EFFECTIVENESS

Chloride Method for the Bayer ADVIA 1650 (mmol/L)

Intended Use

This in vitro diagnostic assay is intended to measure chloride concentration in human serum, plasma and urine on an ADVIA® 1650 Chemistry System. Such measurements are used for their inferential value and are helpful in diagnosing disorders of acid-base and water balance. It is especially important to measure chloride during the correction of hypokalemic alkalosis and also during severe, prolonged vomiting, which can lower the serum chloride level.

Imprecision

Advia 1650
Specimen
typeLevelTotal
CV (%)
Serum88.41.6
Serum111.82.0
Urine86.81.7
Urine290.43.8

Beckman CX7=Serum,Urine Total CV (%) Level 80 1.3 118.8 1.1 89.4 3.4 250 ાં ર

Technicon DAX=Serum

LevelTotal CV (%)
971.5
1121.8

Correlation (Y=ADVIA 1650, X=comparison system)

Specimen typeComparison System (X)NRegression EquationSyxRSample Range
Serum - ARICX7115$Y=1.00X + 1.3$1.60.98576 - 128
Serum - MSKDAX154$Y=0.98X + 3.3$2.20.91486 - 122
Plasma(y), Serum(x)ADVIA 165069$Y=0.86X+15.9$1.200.944102-118
Urine - ARICX776$Y=1.05X - 0.9$4.90.99629 - 280

Interfering Substances

| Interfering
Substance | Interfering
Sub. Conc.
(mg/dL) | Analyte
conc. | Effect | |
|--------------------------|--------------------------------------|------------------|--------|-----|
| Bilirubin | 25 | 85.0 | 0.4 | 0.5 |
| Hemoglobin | 500 | 82.7 | 0.0 | 0.0 |
| Lipids (Trig) | 500 | 83.3 | 2.4 | 2.9 |

Analytical Range

Serum/Plasma:15 to 200 mmol/L
Urine:15 to 400 mmol/L
Serum:98 - 107 mEq/L
Urine:110 - 250 mmol/d

7

7. СК

SUMMARY OF SAFETY AND EFFECTIVENESS

Creatine Phosphokinase Method for the Bayer ADVIA 1650 (U/L)

Intended Use

This in vitro diagnostic assay is intended to measure creatine kinase activity in human serum and plasma on an ADVIA® 1650 Chemistry System. Such measurements are used mainly in the diagnosis and treatment of myocardial infarction and muscle diseases such as Duchenne progressive muscular dystrophy.

Imprecision

Advia 1650Technicon DAXBeckman CX7
Specimen
typeLevelTotal
CV (%)Level (U/L)Total
CV (%)LevelTotal
CV (%)
Serum1392.71774.81445.3
Serum4493.05902.54605.3

Correlation (Y=ADVIA 1650, X=comparison system)

| Specimen type: Site | Comparison
System (X) | N | Regression
Equation | Syx | R | Sample
Range |
|---------------------|--------------------------|-----|------------------------|------|-------|-----------------|
| Serum: MSK | DAX | 151 | Y=0.97X+1.19 | 3.3 | 0.999 | 6-700 |
| Serum: ARI | CX7 | 145 | Y=1.01X+0.8 | 6.50 | 1.000 | 13-1187 |
| Plasma(y), Serum(x) | ADVIA 1650 | 56 | Y=1.05X-9.02 | 7.88 | 0.997 | 41-507 |

Interfering Substances

| Interfering
Substance | Interfering
Sub. Conc.
(mg/dL) | Analyte
conc. | Effect | |
|--------------------------|--------------------------------------|------------------|--------|------|
| Bilirubin | 25 | 70.0 | 2.7 | 3.9 |
| Hemoglobin | 500 | 98.0 | 24.3 | 24.8 |
| Lipids (Trig) | 500 | 65.0 | 6.0 | 9.2 |

Analytical Range

0-1300 U/L

Expected Values

M: 38 - 174 U/L.

F: 26 - 140 U/L.

8

8. CREAT

SUMMARY OF SAFETY AND EFFECTIVENESS

Creatinine Method for the Bayer ADVIA 1650 (mg/dL)

Intended Use

This in vitro diagnostic assay is intended to measure creatinine concentration in human serum, plasma and urine on the ADVIA® 1650 system. Such measurements are used in the diagnosis and treatment of renal diseases, and in monitoring renal dialysis.

Imprecision

Advia 1650Technicon DAX=Serum
Specimen typeLevelTotal CV %LevelTotal CV (%)
Serum1.83.81.84.3
Serum8.43.75.04.5
Urine84.62.910.53.7
Urine209.34.0

Correlation (Y=ADVIA 1650, X=comparison system)

ComparisonRegressionSample
Specimen type: SiteSystem (X)NEquationSyxRRange
Serum: BERLINDAX112Y=0.92X+0.060.150.9950.33-8.3
Plasma(y), Serum(x)ADVIA 165058Y=1.02X+0.040.020.9920.9-1.4
Urine: BERLINHITACHI86Y=1.13X+0.402.610.99521-160

Interfering Substances

| Interfering
Substance | Interfering
Sub. Conc.
(mg/dL) | Analyte
conc. | Effect
conc. | Effect
% |
|--------------------------|--------------------------------------|------------------|-----------------|-------------|
| Bilirubin | 25 | 1.0 | -0.8 | -80.0 |
| Hemoglobin | 500 | 7.3 | 0.1 | 1.4 |
| Lipids (Trig) | 500 | 1.0 | 0.0 | 4.5 |

Analytical Range

Serum/Plasma:0 - 25 mg/dL
Urine:17 - 160 mg/dL
Serum:M: 0.9 - 1.3 mg/dL
F: 0.6 - 1.1 mg/dL.
Urine:M: 14 - 26
F: 11 - 20

9

9. CREAT-E

SUMMARY OF SAFETY AND EFFECTIVENESS

Creatinine-Enzymatic Method for the Bayer ADVIA 1650 (mg/dL)

Intended Use

This in vitro diagnostic assay is intended to measure creatinine concentration in human serum and plasma on an ADVIA® 1650 Chemistry System. Such measurements are used in the diagnosis and treatment of renal diseases, and in monitoring renal dialysis.

Imprecision

Advia 1650Technicon DAX
Specimen
typeLevelTotal
CV (%)LevelTotal
CV (%)
Serum0.96.41.84.3
Serum6.12.35.04.5
Serum9.52.010.53.7

Correlation (Y=ADVIA 1650, X=comparison system)

| Specimen type: Site | Comparison
System (X) | N | Regression
Equation | Syx | R | Sample
Range |
|---------------------|--------------------------|-----|------------------------|------|-------|-----------------|
| Serum: MSK | DAX | 155 | Y=0.99X-0.06 | 0.16 | 0.955 | 0.3-3.9 |
| Plasma(y), Serum(x) | ADVIA 1650 | 57 | Y=0.96X+0.16 | 0.07 | 0.925 | 0.7-1.4 |

Interfering Substances

| Interfering
Substance | Interfering
Sub. Conc.
(mg/dL) | Analyte
conc. | Effect | |
|--------------------------|--------------------------------------|------------------|--------|--------|
| | | | conc. | % |
| Bilirubin | 25 | 0.7 | -0.2 | -28.6 |
| Hemoglobin | 500 | 7.8 | -0.1 | -1.3 |
| Lipids (Trig) | 500 | 0.7 | -1.2 | -171.4 |

Analytical Range

0-30 mg/dL

Expected Values

M: 0.9 - 1.3 mg/dL, F: 0.6 - 1.1 mg/dL.

10

10. DBILI

SUMMARY OF SAFETY AND EFFECTIVENESS

Direct Bilirubin Method for the Bayer ADVIA 1650 (mg/dL)

Intended Use

This in vitro diagnostic assay is intended to measure direct bilirubin concentration in human serum and plasma on the ADVIA® 1650 Chemistry System. Such measurements are used in the diagnosis of common bile duct obstruction caused by a stone and of patients with Dubin-Johnson syndrome.

Imprecision

A do ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Advia 1650Technicon DAX
Specimen
typeLevelTotal
CV (%)LevelTotal
CV (%)
Serum0.34.60.2**
Serum1.64.41.55.7
4.02.3

** Value not significant when level approaches zero.

Correlation (Y=ADVIA 1650, X=comparison system)

Specimen typeComparison System (X)NRegression EquationSyxRSample Range
Serum - TRYTNDAX145Y=1.34X - 0.100.180.9940 - 6.12
Serum - BERLINHITACHI92Y=1.07X + 0.060.140.9970.02 - 9.26
Plasma (y), Serum (x)ADVIA 165049Y=0.98X-0.010.020.9880.1-0.6

Interfering Substances

| Interfering
Substance | Interfering
Sub. Conc.
(mg/dL) | Analyte
conc. | Effect | % |
|--------------------------|--------------------------------------|------------------|--------|---|
| Hemoglobin | 200 | 0.3 | -0.6 | . |
| Hemoglobin | 500 | 0.3 | -1.5 | . |
| Lipids (Trig) | 500 | 0.2 | -0.5 | . |

Analytical Range

0 - 10 mg/dL (from reagent stability study)

Expected Values