8 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM
Device Facts
| Record ID | K992662 |
|---|---|
| Device Name | 8 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM |
| Applicant | Bayer Corp. |
| Product Code | MSJ · Clinical Chemistry |
| Decision Date | Feb 15, 2000 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1475 |
| Device Class | Class 1 |
Intended Use
The Bayer ADVIA 1650 Apolipoprotein A-1 (APO-A) assay is an in vitro diagnostic method intended to measure Apolipoprotein A-1 concentration in human serum and plasma on an Advia 1650 Chemistry System. Measurements are used to aid in the assessment of risk for arteriosclerosis and coronary artery disease. The Bayer ADVIA 1650 Apolipoprotein B (APO-B) assay is an in vitro diagnostic method intended to measure Apolipoprotein B concentration in human serum and plasma on an Advia 1650 Chemistry System. Measurements are used to aid in the assessment of risk for arteriosclerosis and coronary artery disease. The Bayer ADVIA 1650 Carbon Dioxide (CO2) assay is an in vitro diagnostic method intended to measure Carbon Dioxide concentration in human serum and plasma on an Advia 1650 Chemistry System. Measurements obtained using this method assist in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance. The Bayer ADVIA 1650 C-Reactive Protein (CRP) assay is an in vitro diagnostic method intended to measure C-Reactive Protein concentration in human serum and plasma on an Advia 1650 Chemistry System. Measurements are used to aid in the evaluation of the amount of injury to body tissues. This test is useful in following the progress of rheumatic fever, rheumatoid arthritis, myocardial infarction, and malignancies. The Bayer ADVIA 1650 Immunoglobulin A (IGA) assay is an in vitro diagnostic method intended to measure Immunoglobulin A (IGA) concentration in human serum and plasma on an Advia 1650 Chemistry System. Measurements are used to aid in the diagnosis of abnormal protein metabolism and the body's inability to resist infectious agents. The Bayer ADVIA 1650 Immunoglobulin G (IGG) assay is an in vitro diagnostic method intended to measure Immunoglobulin G (IGG) concentration in human serum and plasma on an Advia 1650 Chemistry System. Measurements are used to aid in the diagnosis of abnormal protein metabolism and the body's inability to resist infectious agents. The Bayer ADVIA 1650 Immunoglobulin M (IGM) assay is an in vitro diagnostic method intended to measure Immunoglobulin M (IGM) concentration in human serum and plasma on an Advia 1650 Chemistry System. Measurements are used to aid in the diagnosis of abnormal protein metabolism and the body's inability to resist infectious agents. The Bayer ADVIA 1650 Transferrin (TFR) assay is an in vitro diagnostic device intended to measure Transferrin concentration in human serum and plasma on an Advia 1650 Chemistry System. Such measurements are used to aid in the diagnosis of malnutrition, chronic infection, acute hepatitis, polycythemia, pernicious anemia, and red blood cell disorders, such as iron deficiency anemia.
Device Story
ADVIA 1650 Chemistry System performs automated in vitro diagnostic assays on human serum and plasma samples. System utilizes specific reagents for Apolipoprotein A-1, Apolipoprotein B, CO2, CRP, IgA, IgG, IgM, and Transferrin. Operation occurs in clinical laboratory settings by trained technicians. Device measures analyte concentrations to assist physicians in diagnosing conditions including arteriosclerosis, coronary artery disease, acid-base disorders, tissue injury, rheumatic/autoimmune conditions, protein metabolism abnormalities, and iron deficiency anemia. Output provided as quantitative concentration values (mg/dL, mg/L, or mEq/L) used by clinicians to guide treatment and monitor disease progression.
Clinical Evidence
Bench testing only. Performance validated via correlation studies against predicate systems (N=56-146 per assay) and imprecision studies (Total CV% ranging from 1.7% to 13.6%). Interference testing conducted for bilirubin, hemoglobin, and lipids. No clinical prospective/retrospective trials performed.
Technological Characteristics
Automated chemistry analyzer platform. Assays utilize specific chemical/immunological reagents. Connectivity: Standalone clinical laboratory system. Software: Embedded firmware for instrument control and data processing. Sterilization: Not applicable (reagents/instrument).
Indications for Use
Indicated for patients requiring clinical laboratory assessment of apolipoprotein A-1/B (cardiovascular risk), carbon dioxide (acid-base balance), C-reactive protein (tissue injury/inflammation), immunoglobulins A/G/M (protein metabolism/immune function), and transferrin (anemia/nutritional status). Used for serum and plasma analysis.
Regulatory Classification
Identification
A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
Predicate Devices
- Behring Nephelometer (OUED)
- Behring Nephelometer (OSAN)
- Technicon DAX (T09B-100-06)
- Behring Nephelometer (OQIY21)
- Behring Nephelometer (OSAR)
- Behring Nephelometer (OSAS)
- Behring Nephelometer (OSAT)
- Behring Nephelometer (OSAX)
Related Devices
- K042521 — VITROS CHEMISTRY PRODUCTS APOA1 AND APOB REAGENTS, CALIBRATOR KITS 21 AND 22 AND APOA1 AND APOB PERFORMANCE VERIFIERS · Ortho-Clinical Diagnostics, Inc. · Nov 18, 2004
- K991907 — ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM · Bayer Corp. · Nov 9, 1999
- K964010 — IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN A-1 REAGENT (APA)/ IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN B REAGENT · Beckman Instruments, Inc. · Feb 10, 1997
- K061377 — APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS · Pointe Scientific, Inc., · Mar 28, 2007
- K992399 — ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM · Bayer Corp. · Sep 15, 1999
Submission Summary (Full Text)
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FEB 1 5 2000
## SUMMARY OF SAFETY AND EFFECTIVENESS
This section contains performance comparisons for 8 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.
| Method | ADVIA 1650<br>Reagent Part # | Specimen<br>Type | Predicate Device<br>Name | Predicate Device<br>Reagent Part # |
|--------------------|------------------------------|------------------|--------------------------|------------------------------------|
| Apolipoprotein A-1 | B01-4154-01 | Serum | Behring Nephelometer | OUED |
| Apolipoprotein B | B01-4155-01 | Serum | Behring Nephelometer | OSAN |
| CO2 | B01-4146-01 | Serum | Technicon DAX | T09B-100-06 |
| CRP | B01-4158-01 | Serum | Behring Nephelometer | OQIY21 |
| lgA | B01-4149-01 | Serum | Behring Nephelometer | OSAR |
| IgG | B01-4150-01 | Serum | Behring Nephelometer | OSAS |
| lgM | B01-4151-01 | Serum | Behring Nephelometer | OSAT |
| Transferrin | B01-4152-01 | Serum | Behring Nephelometer | OSAX |
Gabriel J. Muraca Jr.
1/3/2000
---
Date
Gabriel J. Muraca, Jr. Manager, Regulatory Affairs Bayer Corporation 511 Benedict Ave. Tarrytown, NY 10591-5097
Date
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## 1. APO A-1
## SUMMARY OF SAFETY AND EFFECTIVENESS
## Apolipoprotein A-1 Method for the Bayer ADVIA 1650 (mg/dL)
## Intended Use
This in vitro diagnostic assay is intended to measure apolipoprotein A-1 concentration in human serum and plasma on the ADVIA® 1650 Chemistry System. Such measurements are used to aid in the assessment of risk for arteriosclerosis and coronary artery disease.
## Imprecision
ADVIA 1650
| Specimen<br>Type | Level | Total<br>CV% |
|------------------|-------|--------------|
| Serum | 77.6 | 4.5 |
| Serum | 216.4 | 4.1 |
| Level | Between Day CV% |
|-------|-----------------|
| 145.3 | 5.7 |
## Correlation (Y=ADVIA 1650, X=comparison system)
| Specimen type: Site | Comparison System (X) | N | Regression Equation | Syx | R | Sample Range |
|---------------------|-----------------------|----|---------------------|------|-------|--------------|
| Serum: ARI | BEHRING | 78 | $Y=0.70X-1.48$ | 5.49 | 0.986 | 48-273 |
| Plasma(y), Serum(x) | ADVIA 1650 | 72 | $Y=0.99X-0.38$ | 2.10 | 0.996 | 89.7-206.8 |
## Interfering Substances
| Interfering<br>Substance | Interfering<br>Sub. Conc.<br>(mg/dL) | Analyte<br>Conc. | Effect | |
|--------------------------|--------------------------------------|------------------|--------|------|
| Bilirubin | 30 | 42.8 | 0.78 | 1.9% |
| Hemoglobin | 525 | 40.3 | 1.77 | 4.2% |
| Lipids(Trig) | 650 | 42.1 | 0.04 | 0.1% |
| Bilirubin | 30 | 126.3 | 1.30 | 1.0% |
| Hemoglobin | 525 | 124.6 | 0.47 | 0.4% |
| Lipids(Trig) | 650 | 122.1 | 2.07 | 1.7% |
## Analytical Range
The analytical range for this method extends from 15 mg/dL to the APO A-1 concentration level in Apolipoprotein Calibrator Level 4.
## Expected Values
79 mg/dL to 187 mg/dL
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## 2. APO B
### SUMMARY OF SAFETY AND EFFECTIVENESS
### Apolipoprotein B Method for the Bayer ADVIA 1650 (mg/dL)
### Intended Use
This in virro diagnostic assay is intended to measure apolipoprotein B concentration in human serum and plasma on the ADVIA® 1650 Chemistry System. Such measurements are used to aid in the assessment of risk for arteriosclerosis and coronary artery disease.
### Imprecision
ADVIA 1650
| Specimen<br>Type | Level | Total<br>CV% |
|------------------|-------|--------------|
| Serum | 29 | 5.7 |
| Serum | 110.5 | 3.3 |
| Behring Nephelometer=Serum | |
|----------------------------|-----------------|
| Level | Between Day CV% |
| 108 | 2.4 |
### Correlation (Y=ADVIA 1650, X=comparison system)
| Specimen type: Site | Comparison System (X) | N | Regression Equation | Syx | R | Sample Range |
|---------------------|-----------------------|----|---------------------|------|-------|--------------|
| Serum: Tarrytown | BEHRING | 59 | Y=1.03X+0.53 | 3.66 | 0.993 | 42.1-172.8 |
| Plasma(y), Serum(x) | ADVIA 1650 | 71 | Y=1.00X-1.67 | 1.74 | 0.997 | 49.6-157.8 |
### Interfering Substances
| Interfering<br>Substance | Interfering<br>Sub. Conc.<br>(mg/dL) | Analyte<br>Conc. | Effect<br>Conc. | % |
|--------------------------|--------------------------------------|------------------|-----------------|-----|
| Bilirubin | 30 | 42.8 | 0.08 | 0.2 |
| Hemoglobin | 525 | 41.7 | 0.97 | 2.3 |
| Bilirubin | 30 | 163.6 | 1.61 | 1.0 |
| Hemoglobin | 525 | 159.5 | 4.06 | 2.5 |
### Analytical Range
The analytical range for this method extends from 15 mg/dL to the APO B concentration level in Apolipoprotein Calibrator Level 4.
### Expected Values
Males: 46 mg/dL to 174 mg/dL Females: 46 mg/dL to 142 mg/dL
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3. CO2
### SUMMARY OF SAFETY AND EFFECTIVENESS
## Carbon Dioxide Method for the Bayer ADVIA 1650 (mg/dL)
### Intended Use
This in vitro diagnostic assay is intended to measure carbon dioxide concentration in human serum and plasma on the ADVIA® 1650 Chemistry System. Such measurements assist in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.
### Imprecision
ADVIA 1650
| Specimen<br>Type | Level | Total<br>CV% |
|------------------|-------|--------------|
| Serum | 12.2 | 6.7 |
| Serum | 25.6 | 4.6 |
| Level | Total CV% |
|-------|-----------|
| 13.5 | 6.3 |
| 23.8 | 5.3 |
| 27.4 | 4.5 |
## Correlation (Y=ADVLA 1650, X=comparison system)
| Specimen type: Site | Comparison<br>System (X) | N | Regression<br>Equation | Syx | R | Sample<br>Range |
|---------------------|--------------------------|-----|------------------------|------|-------|-----------------|
| Serum: Tarrytown | DAX | 146 | Y=0.90X-0.86 | 1.26 | 0.963 | 11.0-36.0 |
| Plasma(y), Serum(x) | ADVIA 1650 | 79 | Y=0.94X+0.08 | 1.98 | 0.839 | 14.2-27.0 |
### Interfering Substances
| Interfering<br>Substance | Interfering<br>Sub. Conc.<br>(mg/dL) | Analyte<br>Conc. | Effect | |
|--------------------------|--------------------------------------|------------------|--------|------|
| Bilirubin | 30 | 17.1 | 0.8 | 5.4% |
| Hemoglobin | 525 | 13.9 | 0.9 | 6.4% |
| Lipids(Trig) | 650 | 14.1 | 0.4 | 2.8% |
| Bilirubin | 30 | 34.0 | 2.8 | 8.5% |
| Hemoglobin | 525 | 33.5 | 0.6 | 2.0% |
| Lipids(Trig) | 650 | 32.9 | 0.0 | 0.0% |
## Analytical Range
10-40 mEq/L
## Expected Values
Serum: 23 - 29 mEq/L Plasma: 22 - 28 mEq/L
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4. CRP
## SUMMARY OF SAFETY AND EFFECTIVENESS
## C-Reactive Protein Method for the Bayer ADVIA 1650 (mg/L)
## Intended Use
This in vitro diagnostic assay is intended to measure C-reactive protein concentration in human serum on the ADVIA® 1650 Chemistry System. Such measurements are used in the evaluation of the amount of injury to body tissues. This test is useful in following the progress of rheumatic fever, rheumatoid arthritis, myocardial infarction and malignancies.
## Imprecision
ADVIA 1650
| Specimen<br>Type | Level | Total<br>CV% |
|------------------|-------|--------------|
| Serum | 5 | 13.6 |
| Serum | 42 | 4.6 |
| Behring Nephelometer=Serum | |
|----------------------------|-----------------|
| Levels | Between Day CV% |
| 10,15,25,45,60 | 2.6 to 5.7 |
## Correlation (Y=ADVIA 1650, X=comparison system)
| Specimen type: Site | Comparison System (X) | N | Regression Equation | Syx (mg/L) | R | Sample Range (mg/L) |
|---------------------|-----------------------|----|---------------------|------------|-------|---------------------|
| Serum: Tarrytown | BEHRING | 56 | Y=0.96X-3.33 | 2.34 | 0.984 | 5.4-67.7 |
## Interfering Substances
| Interfering<br>Substance | Interfering<br>Sub. Conc.<br>(mg/dL) | Analyte<br>Conc. | Effect<br>Conc. | Effect<br>% |
|--------------------------|--------------------------------------|------------------|-----------------|-------------|
| Bilirubin | 30 | 9.6 | 3.06 | 24.2% |
| Hemoglobin | 525 | 11.3 | 1.37 | 10.8% |
| Lipids(Trig) | 60* | 12.5 | 0.20 | 1.4% |
| Bilirubin | 30 | 39.1 | 0.58 | 1.5% |
| Hemoglobin | 525 | 37.0 | 2.67 | 6.7% |
| Lipids(Trig) | 650 | 25.6 | 14.0 | 35.4% |
* Levels tested above 60 mg/dL caused a high interference and no results were generated.
## Analytical Range
The analytical range for this method extends from 5 mg/L to the level in CRP Calibrator Level 5.
## Expected Values
Less than 10 mg/L
## ADVIA 1650 Summary of Safety and Effectiveness
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5. IgA
### SUMMARY OF SAFETY AND EFFECTIVENESS
#### Immunoglobulin A Method for the Bayer ADVIA 1650 (mg/dL)
#### Intended Use
This in vitro diagnostic assay is intended to measure immunoglobulin A concentration in human serum and plasma on the ADVIA® 1650 Chemistry System. Such measurements are used to aid in the diagnosis of abnormal protein metabolism and the body's inability to resist infectious agents.
#### Imprecision
ADVIA 1650
| Specimen<br>Type | Level | Total<br>CV% | Behring Nephelometer=Serum | | |
|------------------|-------|--------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|--|
| Serum | 150.5 | 2 | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | Between Day CV% | |
| Serum | 405.7 | 2 | Level | an anywald be a seems of the click of the of the of the click of can and the first and the first and the first and | |
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|----------------|--|
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#### Correlation (Y=ADVIA 1650, X=comparison system)
| Specimen type: Site | Comparison System (x) | N | Regression Equation | Sy.x (mg/dL) | R | Sample Range (mg/dL) |
|-----------------------------|-----------------------|----|---------------------|--------------|-------|----------------------|
| Serum: Tarrytown | BEHRING | 74 | $y=1.02X-1.34$ | 14.28 | 0.997 | 103-1110 |
| EDTA Plasma(y), Serum(x) | ADVIA 1650 | 68 | $y=0.92X+1.48$ | 13.99 | 0.986 | 85.7-517.9 |
| Heparin Plasma(y), Serum(x) | ADVIA 1650 | 69 | $y=0.97X+2.08$ | 19.42 | 0.975 | 82.9-517.9 |
#### Interfering Substances
| Interfering<br>Substance | Interfering<br>Sub. Conc.<br>(mg/dL) | Analyte<br>Conc. | Effect | |
|--------------------------|--------------------------------------|------------------|--------|--------|
| Bilirubin | 30 | 131.6 | 17.7 | 15.6% |
| Hemoglobin | 525 | 142.9 | 29.1 | 25.5% |
| Lipids(Trig) | 650 | 367.1 | 253.2 | 222.4% |
| Bilirubin | 30 | 362.5 | 14.5 | 4.2% |
| Hemoglobin | 525 | 379.9 | 31.9 | 9.2% |
| Lipids(Trig) | 650 | 629.8 | 281.8 | 81.0% |
#### Analytical Range
The analytical range for this method extends from 15 mg/dL to the IgA concentration level in Specific Protein Reference Serum Calibrator Level 5.
#### Expected Values
40 to 350 mg/dL
ADVIA 1650 Summary of Safety and Effectiveness 11/12/99
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6. IgG
## SUMMARY OF SAFETY AND EFFECTIVENESS
## Immunoglobulin G Method for the Bayer ADVIA 1650 (mg/dL)
### Intended Use
This in vitro diagnostic assay is intended to measure immunoglobulin G concentration in human serum and plasma on the ADVIA® 1650 Chemistry System. Such measurements are used to aid in the diagnosis of abnormal protein metabolism and the body's inability to resist infectious agents.
### Imprecision
ADVIA 1650
| Specimen<br>Type | Level | Total<br>CV% |
|------------------|-------|--------------|
| Serum | 926.7 | 2.4 |
| Serum | 2946 | 1.7 |
| Level | Between Day CV% |
|-------|-----------------|
| 1317 | 2.7 |
## Correlation (Y=ADVIA 1650, X=comparison system)
| Specimen type: Site | Comparison<br>System (x) | N | Regression<br>Equation | Sy.x<br>(mg/dL) | R | Sample<br>Range<br>(mg/dL) |
|-----------------------------|--------------------------|----|------------------------|-----------------|-------|----------------------------|
| Serum: Tarrytown | BEHRING | 60 | $y=1.04X-32.0$ | 78.46 | 0.999 | 574-5392 |
| EDTA Plasma(y), Serum(x) | ADVIA 1650 | 72 | $y=0.97X-30.0$ | 51.13 | 0.974 | 527-1537 |
| Heparin Plasma(y), Serum(x) | ADVIA 1650 | 73 | $y=0.97X+11.4$ | 63.28 | 0.962 | 527-1537 |
## Interfering Substances
| Interfering<br>Substance | Interfering<br>Sub. Conc.<br>(mg/dL) | Analyte<br>Conc. | Effect | |
|--------------------------|--------------------------------------|------------------|--------|-------|
| Bilirubin | 30 | 719.5 | 27.7 | 4.0% |
| Hemoglobin | 525 | 723.0 | 31.2 | 4.5% |
| Lipids(Trig) | 650 | 1034.3 | 342.5 | 49.5% |
| Bilirubin | 30 | 2153.9 | 64.2 | 3.1% |
| Hemoglobin | 525 | 2149.6 | 59.9 | 2.9% |
| Lipids(Trig) | 650 | 2553.3 | 463.6 | 22.2% |
## Analytical Range
The analytical range for this method extends from 85 mg/dL to the IgG concentration level in Specific Protein Reference Serum Calibrator Level 5
11/12/99
## Expected Values
650 to 1600 mg/dL
ADVIA 1650 Summary of Safety and Effectiveness
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7. IgM
### SUMMARY OF SAFETY AND EFFECTIVENESS
### Immunoglobulin M Method for the Bayer ADVIA 1650 (mg/dL)
#### Intended Use
This in vitro diagnostic assay is intended to measure immunoglobulin M concentration in human serum and plasma on the ADVIA® 1650 Chemistry System. Such measurements are used to aid in the diagnosis of abnormal protein metabolism and the body's inability to resist infectious agents.
### Imprecision
ADVIA 1650
| Specimen<br>Type | Level | Total<br>CV% |
|------------------|-------|--------------|
| Serum | 54.8 | 7.4 |
| Serum | 172.8 | 3.7 |
| Level | Between Day CV% |
|-------|-----------------|
| 117 | 1.9 |
### Correlation (Y=ADVIA 1650, X=comparison system)
| Specimen type: Site | Comparison System (x) | N | Regression Equation | Sy.x (mg/dL) | R | Sample Range (mg/dL) |
|-----------------------------|-----------------------|----|---------------------|--------------|-------|----------------------|
| Serum: Tarrytown | BEHRING | 74 | y=0.76X+17.9 | 7.91 | 0.98 | 26.8-300.8 |
| EDTA Plasma(y), Serum(x) | ADVIA 1650 | 69 | y=0.99X-4.27 | 8.75 | 0.989 | 35.6-293.1 |
| Heparin Plasma(y), Serum(x) | ADVIA 1650 | 70 | y=0.99X-0.23 | 11.13 | 0.982 | 35.6-293.1 |
### Interfering Substances
| Interfering<br>Substance | Interfering<br>Sub. Conc.<br>(mg/dL) | Analyte<br>Conc. | Effect | |
|--------------------------|--------------------------------------|------------------|--------|--------|
| Bilirubin | 30 | 75.6 | 21.9 | 40.8% |
| Hemoglobin | 525 | 103.0 | 49.3 | 91.8% |
| Lipids(Trig) | 650 | 367.6 | 313.8 | 584.2% |
| Bilirubin | 30 | 181.0 | 24.6 | 15.8% |
| Hemoglobin | 525 | 210.0 | 53.7 | 34.4% |
| Lipids(Trig) | 650 | 487.1 | 330.8 | 211.6% |
### Analytical Range
The analytical range for this method extends from 12 mg/dL to the IgM concentration level in Specific Protein Reference Serum Calibrator Level 5.
#### Expected Values
50 to 300 mg/dL
ADVIA 1650 Summary of Safety and Effectiveness 11/12/99
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## 8. Transferrin
## SUMMARY OF SAFETY AND EFFECTIVENESS
### Transferrin Method for the Bayer ADVIA 1650 (mg/dL)
#### Intended Use
This in vitro diagnostic assay is intended to measure transferrin concentration in human serum and plasma on the ADVIA® 1650 Chemistry System. Such measurements are used to aid in the diagnosis of malnutrition, chronic infection, acute hepatitis, polycythemia, permicious anemia, and red blood cell disorders, such as iron deficiency anemia.
### Imprecision
### ADVIA 1650
| Specimen<br>Type | Level | Total<br>CV% |
|------------------|-------|--------------|
| Serum | 193.9 | 4.7 |
| Serum | 473.1 | 3.7 |
| Level | Between Day CV% |
|-------|-----------------|
| 303 | 2.3 |
### Correlation (Y=ADVIA 1650, X=comparison system)
| Specimen type: Site | Comparison<br>System(X) | N | Regression<br>Equation | Sy.x | R | Sample<br>Range |
|-----------------------------|-------------------------|----|------------------------|------|-------|-----------------|
| Serum: Tarrytown | BEHRING | 78 | $Y=1.20X-39.2$ | 10.6 | 0.976 | 161-344 |
| EDTA Plasma(y), Serum(x) | ADVIA 1650 | 71 | $Y=0.94X-5.51$ | 5 | 0.993 | 196-402 |
| Heparin Plasma(y), Serum(x) | ADVIA 1650 | 72 | $Y=0.98X-8.45$ | 7.31 | 0.987 | 196-402 |
### Interfering Substances
| Interfering<br>Substance | Interfering<br>Sub. Conc.<br>(mg/dL) | Analyte<br>Conc. | Effect | |
|--------------------------|--------------------------------------|------------------|--------|------|
| Bilirubin | 30 | 122.5 | 0.11 | 0.1% |
| Hemoglobin | 525 | 124.6 | 1.93 | 1.6% |
| Lipids(Trig) | 650 | 132.9 | 10.24 | 8.4% |
| Bilirubin | 30 | 370.4 | 3.43 | 0.9% |
| Hemoglobin | 525 | 376.0 | 2.16 | 0.6% |
| Lipids(Trig) | 650 | 372.7 | 1.15 | 0.3% |
### Analytical Range
The analytical range for this method extends from the lowest calibration value of Specific Protein Reference Serum Level 1 to the Transferrin concentration level in Specific Protein Reference Serum Level 5.
{9}------------------------------------------------
Transferrin (continued)
## Expected Values
215 mg/dL to 365 mg/dL Males: Females: 250 mg/dL to 380 mg/dL
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#### DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/10/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES U.S.A." arranged around the perimeter. Inside the circle is a stylized image of three human figures, possibly representing health, family, and community. The figures are connected and appear to be in motion.
#### Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
# JUN 1 8 2002
Mr. Gabriel J. Muraca, Jr. Manager Regulatory Affairs c/o Kenneth T, Edds, Ph.D. Manager Regulatory Affairs Bayer Diagnostics 511 Benedict Avenue Tarrytown, NY 10591
Re: k992662
Trade/Device Name: Bayer ADVIA® 1650 Additional Assays Regulation Number: 21 CFR 862.1475 Regulation Name: Lipoprotein Test System Regulatory Class: II Product Code: MSJ, CFN, DCN, JNM, KHS Dated: January 3, 2002 Received: January 5, 2002
Dear Dr. Edds:
This letter corrects our substantially equivalent letter of dated February 15, 2000, regarding the missing product codes cleared for use in the determination.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the original enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
{11}------------------------------------------------
#### Page 2
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594 of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Sean M. Cooper, M.S., D.U.M.
Jean M. Cooper, M.S., D.V.M. Branch Chief Chemistry and Toxicology I Branch Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
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Page 1 of 3
510(k) Number (if known):
#### Device Name: Bayer ADVIA® 1650 Additional Assays
Indications For Use:
The Bayer ADVIA 1650 Apolipoprotein A-1 (APO-A) assay is an in vitro diagnostic method intended to measure Apolipoprotein A-1 concentration in human serum and plasma on an Advia 1650 Chemistry System. Measurements are used to aid in the assessment of risk for arteriosclerosis and coronary artery disease.
The Bayer ADVIA 1650 Apolipoprotein B (APO-B) assay is an in vitro diagnostic method intended to measure Apolipoprotein B concentration in human serum and plasma on an Advia 1650 Chemistry System. Measurements are used to aid in the assessment of risk for arteriosclerosis and coronary artery disease.
The Bayer ADVIA 1650 Carbon Dioxide (CO2) assay is an in vitro fliagnostic method intended to measure Carbon Dioxide concentration in human serum and plasma on an Advia 1650 Chemistry System. Measurements obtained using this method assist in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.
The Bayer ADVIA 1650 C-Reactive Protein (CRP) assay is an in vitro diagnostic method intended to measure C-Reactive Protein concentration in human serum and plasma on an Advia 1650 Chemistry System. Measurements are used to aid in the evaluation of the amount of injury to body tissues. This test is useful in following the progress of rheumatic fever, rheumatoid arthritis, myocardial infarction, and malignancies.
(Division Sign-Off)
ision of Clinical Laboratory Devices
| c) Number | K992662 |
|-----------|---------|
|-----------|---------|
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | | |
|--------------------------------------------------------|----|----------------------|
| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-The-Counter Use |
(Optional Format 1-2-96)
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Page 2 of 3
510(k) Number (if known):
### Device Name: Bayer ADVIA® 1650 Additional Assays
Indications For Use:
The Bayer ADVIA 1650 Immunoglobulin A (IGA) assay is an in vitro diagnostic method intended to measure Immunoglobulin A (IGA) concentration in human serum and plasma on an Advia 1650 Chemistry System. Measurements are used to aid in the diagnosis of abnormal protein metabolism and the body's inability to resist infectious agents.
The Bayer ADVIA 1650 Immunoglobulin G (IGG) assay is an in vitro diagnostic method intended to measure Immunoglobulin G (IGG) concentration in human serum and plasma on an Advia 1650 Chemistry System. Measurements are used to aid in the diagnosis of abnormal protein metabolism and the body's inability to resist infectious agents.
The Bayer ADVIA 1650 Immunoglobulin M (IGM) assay is an in vitro diagnostic method intended to measure Immunoglobulin M (IGM) concentration in human serum and plasma on an Advia 1650 Chemistry System. Measurements are used to aid in the diagnosis of abnormal protein metabolism and the body's inability to resist infectious agents.
Sean Cooper
(Division Sign-Off
Division of Jime
510(k) Number K992662
## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH. Office of Device Evaluation (ODE)
Prescription Use_ (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
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Page 3 of 3
510(k) Number (if known):
# Device Name: Bayer ADVIA® 1650 Additional Assays
Indications For Use:
The Bayer ADVIA 1650 Transferrin (TFR) assay is an in vitro diagnostic device intended to The Bayer ADV IA 1650 Transferrin (111) assa is and plasmo on an Advia 1650 Chemistry measure Transferrin concentration in hammir so and more of malmutrition, chronic infection,
System. Such measurements are used to aid in the coll disorders, such as inon System. Such measurements are used to are in the diagneers over in the arrant deficiency anemia.
(Division Sign-Off)
Division of Clinical Laborato
510(k) Number 14992662
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| | Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--|--------------------------------------------------------|--|
|--|--------------------------------------------------------|--|
| Prescription Use _ | OR | Over-The-Counter Use _ |
|----------------------|----|--------------------------|
| (Per 21 CFR 801.109) | | (Optional Format 1-2-96) |
