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K Number
K992662
Device Name
8 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM
Manufacturer
BAYER CORP.
Date Cleared
2000-02-15

(190 days)

Product Code
MSJCFNDCNJNMKHS
Regulation Number
862.1475
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 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. 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 Description
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More Information

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No
The summary describes standard in vitro diagnostic assays performed on a chemistry analyzer, with performance studies focused on imprecision and correlation to predicate devices. There is no mention of AI, ML, image processing, or any other indicators of advanced computational techniques beyond typical analytical calculations.

No
The device is described as an "in vitro diagnostic method" used to measure concentrations of various substances in human samples to aid in diagnosis or assessment of risk, not to treat conditions.

Yes

The "Intended Use / Indications for Use" section explicitly states that the assays are "in vitro diagnostic methods" and are "used to aid in the assessment of risk," "assist in the diagnosis and treatment," or "aid in the diagnosis" of various conditions. This directly aligns with the definition of a diagnostic device.

No

The device is described as an "in vitro diagnostic method" intended to measure concentrations in human serum and plasma on an "Advia 1650 Chemistry System." This indicates it is part of a larger hardware system (the Advia 1650 Chemistry System) and involves physical assays, not solely software.

Yes, this device is an IVD (In Vitro Diagnostic).

The "Intended Use / Indications for Use" section explicitly states for each assay that it is an "in vitro diagnostic method intended to measure..." various substances in human serum and plasma. This directly aligns with the definition of an in vitro diagnostic device, which is used to examine specimens from the human body to provide information for diagnosis, treatment, or prevention of disease.

N/A

Intended Use / 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.

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 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.

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

MSJ, CFN, DCN, JNM, KHS

Device Description

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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

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Indicated Patient Age Range

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Intended User / Care Setting

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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)

Apolipoprotein A-1 Method for the Bayer ADVIA 1650 (mg/dL)

  • Imprecision (ADVIA 1650)
    • Serum: 77.6, Total CV% 4.5
    • Serum: 216.4, Total CV% 4.1
    • Level 145.3, Between Day CV% 5.7
  • Correlation (Y=ADVIA 1650, X=comparison system)
    • Serum: ARI, Comparison System (X) BEHRING, N 78, Regression Equation Y=0.70X-1.48, Syx 5.49, R 0.986, Sample Range 48-273
    • Plasma(y), Serum(x) ADVIA 1650, N 72, Regression Equation Y=0.99X-0.38, Syx 2.10, R 0.996, Sample Range 89.7-206.8
  • Interfering Substances
    • Bilirubin (30 mg/dL), Analyte Conc. 42.8, Effect 0.78, 1.9%
    • Hemoglobin (525 mg/dL), Analyte Conc. 40.3, Effect 1.77, 4.2%
    • Lipids(Trig) (650 mg/dL), Analyte Conc. 42.1, Effect 0.04, 0.1%
    • Bilirubin (30 mg/dL), Analyte Conc. 126.3, Effect 1.30, 1.0%
    • Hemoglobin (525 mg/dL), Analyte Conc. 124.6, Effect 0.47, 0.4%
    • Lipids(Trig) (650 mg/dL), Analyte Conc. 122.1, Effect 2.07, 1.7%
  • Analytical Range: 15 mg/dL to APO A-1 concentration level in Apolipoprotein Calibrator Level 4.
  • Expected Values: 79 mg/dL to 187 mg/dL

Apolipoprotein B Method for the Bayer ADVIA 1650 (mg/dL)

  • Imprecision (ADVIA 1650)
    • Serum: 29, Total CV% 5.7
    • Serum: 110.5, Total CV% 3.3
    • Behring Nephelometer=Serum, Level 108, Between Day CV% 2.4
  • Correlation (Y=ADVIA 1650, X=comparison system)
    • Serum: Tarrytown, Comparison System (X) BEHRING, N 59, Regression Equation Y=1.03X+0.53, Syx 3.66, R 0.993, Sample Range 42.1-172.8
    • Plasma(y), Serum(x) ADVIA 1650, N 71, Regression Equation Y=1.00X-1.67, Syx 1.74, R 0.997, Sample Range 49.6-157.8
  • Interfering Substances
    • Bilirubin (30 mg/dL), Analyte Conc. 42.8, Effect Conc. 0.08, 0.2%
    • Hemoglobin (525 mg/dL), Analyte Conc. 41.7, Effect Conc. 0.97, 2.3%
    • Bilirubin (30 mg/dL), Analyte Conc. 163.6, Effect Conc. 1.61, 1.0%
    • Hemoglobin (525 mg/dL), Analyte Conc. 159.5, Effect Conc. 4.06, 2.5%
  • Analytical Range: 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

Carbon Dioxide Method for the Bayer ADVIA 1650 (mg/dL)

  • Imprecision (ADVIA 1650)
    • Serum: 12.2, Total CV% 6.7
    • Serum: 25.6, Total CV% 4.6
    • Level 13.5, Total CV% 6.3
    • Level 23.8, Total CV% 5.3
    • Level 27.4, Total CV% 4.5
  • Correlation (Y=ADLVIA 1650, X=comparison system)
    • Serum: Tarrytown, Comparison System (X) DAX, N 146, Regression Equation Y=0.90X-0.86, Syx 1.26, R 0.963, Sample Range 11.0-36.0
    • Plasma(y), Serum(x) ADVIA 1650, N 79, Regression Equation Y=0.94X+0.08, Syx 1.98, R 0.839, Sample Range 14.2-27.0
  • Interfering Substances
    • Bilirubin (30 mg/dL), Analyte Conc. 17.1, Effect 0.8, 5.4%
    • Hemoglobin (525 mg/dL), Analyte Conc. 13.9, Effect 0.9, 6.4%
    • Lipids(Trig) (650 mg/dL), Analyte Conc. 14.1, Effect 0.4, 2.8%
    • Bilirubin (30 mg/dL), Analyte Conc. 34.0, Effect 2.8, 8.5%
    • Hemoglobin (525 mg/dL), Analyte Conc. 33.5, Effect 0.6, 2.0%
    • Lipids(Trig) (650 mg/dL), Analyte Conc. 32.9, Effect 0.0, 0.0%
  • Analytical Range: 10-40 mEq/L
  • Expected Values: Serum: 23 - 29 mEq/L, Plasma: 22 - 28 mEq/L

C-Reactive Protein Method for the Bayer ADVIA 1650 (mg/L)

  • Imprecision (ADVIA 1650)
    • Serum: 5, Total CV% 13.6
    • Serum: 42, Total CV% 4.6
    • Behring Nephelometer=Serum, Levels 10,15,25,45,60, Between Day CV% 2.6 to 5.7
  • Correlation (Y=ADVIA 1650, X=comparison system)
    • Serum: Tarrytown, Comparison System (X) BEHRING, N 56, Regression Equation Y=0.96X-3.33, Syx (mg/L) 2.34, R 0.984, Sample Range (mg/L) 5.4-67.7
  • Interfering Substances
    • Bilirubin (30 mg/dL), Analyte Conc. 9.6, Effect Conc. 3.06, Effect% 24.2%
    • Hemoglobin (525 mg/dL), Analyte Conc. 11.3, Effect Conc. 1.37, Effect% 10.8%
    • Lipids(Trig) (60* mg/dL), Analyte Conc. 12.5, Effect Conc. 0.20, Effect% 1.4% (*Levels tested above 60 mg/dL caused a high interference and no results were generated.)
    • Bilirubin (30 mg/dL), Analyte Conc. 39.1, Effect Conc. 0.58, Effect% 1.5%
    • Hemoglobin (525 mg/dL), Analyte Conc. 37.0, Effect Conc. 2.67, Effect% 6.7%
    • Lipids(Trig) (650 mg/dL), Analyte Conc. 25.6, Effect Conc. 14.0, Effect% 35.4%
  • Analytical Range: 5 mg/L to the level in CRP Calibrator Level 5.
  • Expected Values: Less than 10 mg/L

Immunoglobulin A Method for the Bayer ADVIA 1650 (mg/dL)

  • Imprecision (ADVIA 1650)
    • Serum: 150.5, Total CV% 2
    • Serum: 405.7, Total CV% 2
  • Correlation (Y=ADVIA 1650, X=comparison system)
    • Serum: Tarrytown, Comparison System (x) BEHRING, N 74, Regression Equation y=1.02X-1.34, Sy.x (mg/dL) 14.28, R 0.997, Sample Range (mg/dL) 103-1110
    • EDTA Plasma(y), Serum(x) ADVIA 1650, N 68, Regression Equation y=0.92X+1.48, Sy.x (mg/dL) 13.99, R 0.986, Sample Range (mg/dL) 85.7-517.9
    • Heparin Plasma(y), Serum(x) ADVIA 1650, N 69, Regression Equation y=0.97X+2.08, Sy.x (mg/dL) 19.42, R 0.975, Sample Range (mg/dL) 82.9-517.9
  • Interfering Substances
    • Bilirubin (30 mg/dL), Analyte Conc. 131.6, Effect 17.7, 15.6%
    • Hemoglobin (525 mg/dL), Analyte Conc. 142.9, Effect 29.1, 25.5%
    • Lipids(Trig) (650 mg/dL), Analyte Conc. 367.1, Effect 253.2, 222.4%
    • Bilirubin (30 mg/dL), Analyte Conc. 362.5, Effect 14.5, 4.2%
    • Hemoglobin (525 mg/dL), Analyte Conc. 379.9, Effect 31.9, 9.2%
    • Lipids(Trig) (650 mg/dL), Analyte Conc. 629.8, Effect 281.8, 81.0%
  • Analytical Range: 15 mg/dL to the IgA concentration level in Specific Protein Reference Serum Calibrator Level 5.
  • Expected Values: 40 to 350 mg/dL

Immunoglobulin G Method for the Bayer ADVIA 1650 (mg/dL)

  • Imprecision (ADVIA 1650)
    • Serum: 926.7, Total CV% 2.4
    • Serum: 2946, Total CV% 1.7
    • Level 1317, Between Day CV% 2.7
  • Correlation (Y=ADVIA 1650, X=comparison system)
    • Serum: Tarrytown, Comparison System (x) BEHRING, N 60, Regression Equation y=1.04X-32.0, Sy.x (mg/dL) 78.46, R 0.999, Sample Range (mg/dL) 574-5392
    • EDTA Plasma(y), Serum(x) ADVIA 1650, N 72, Regression Equation y=0.97X-30.0, Sy.x (mg/dL) 51.13, R 0.974, Sample Range (mg/dL) 527-1537
    • Heparin Plasma(y), Serum(x) ADVIA 1650, N 73, Regression Equation y=0.97X+11.4, Sy.x (mg/dL) 63.28, R 0.962, Sample Range (mg/dL) 527-1537
  • Interfering Substances
    • Bilirubin (30 mg/dL), Analyte Conc. 719.5, Effect 27.7, 4.0%
    • Hemoglobin (525 mg/dL), Analyte Conc. 723.0, Effect 31.2, 4.5%
    • Lipids(Trig) (650 mg/dL), Analyte Conc. 1034.3, Effect 342.5, 49.5%
    • Bilirubin (30 mg/dL), Analyte Conc. 2153.9, Effect 64.2, 3.1%
    • Hemoglobin (525 mg/dL), Analyte Conc. 2149.6, Effect 59.9, 2.9%
    • Lipids(Trig) (650 mg/dL), Analyte Conc. 2553.3, Effect 463.6, 22.2%
  • Analytical Range: 85 mg/dL to the IgG concentration level in Specific Protein Reference Serum Calibrator Level 5
  • Expected Values: 650 to 1600 mg/dL

Immunoglobulin M Method for the Bayer ADVIA 1650 (mg/dL)

  • Imprecision (ADVIA 1650)
    • Serum: 54.8, Total CV% 7.4
    • Serum: 172.8, Total CV% 3.7
    • Level 117, Between Day CV% 1.9
  • Correlation (Y=ADVIA 1650, X=comparison system)
    • Serum: Tarrytown, Comparison System (x) BEHRING, N 74, Regression Equation y=0.76X+17.9, Sy.x (mg/dL) 7.91, R 0.98, Sample Range (mg/dL) 26.8-300.8
    • EDTA Plasma(y), Serum(x) ADVIA 1650, N 69, Regression Equation y=0.99X-4.27, Sy.x (mg/dL) 8.75, R 0.989, Sample Range (mg/dL) 35.6-293.1
    • Heparin Plasma(y), Serum(x) ADVIA 1650, N 70, Regression Equation y=0.99X-0.23, Sy.x (mg/dL) 11.13, R 0.982, Sample Range (mg/dL) 35.6-293.1
  • Interfering Substances
    • Bilirubin (30 mg/dL), Analyte Conc. 75.6, Effect 21.9, 40.8%
    • Hemoglobin (525 mg/dL), Analyte Conc. 103.0, Effect 49.3, 91.8%
    • Lipids(Trig) (650 mg/dL), Analyte Conc. 367.6, Effect 313.8, 584.2%
    • Bilirubin (30 mg/dL), Analyte Conc. 181.0, Effect 24.6, 15.8%
    • Hemoglobin (525 mg/dL), Analyte Conc. 210.0, Effect 53.7, 34.4%
    • Lipids(Trig) (650 mg/dL), Analyte Conc. 487.1, Effect 330.8, 211.6%
  • Analytical Range: 12 mg/dL to the IgM concentration level in Specific Protein Reference Serum Calibrator Level 5.
  • Expected Values: 50 to 300 mg/dL

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

  • Imprecision (ADVIA 1650)
    • Serum: 193.9, Total CV% 4.7
    • Serum: 473.1, Total CV% 3.7
    • Level 303, Between Day CV% 2.3
  • Correlation (Y=ADVIA 1650, X=comparison system)
    • Serum: Tarrytown, Comparison System (X) BEHRING, N 78, Regression Equation Y=1.20X-39.2, Sy.x 10.6, R 0.976, Sample Range 161-344
    • EDTA Plasma(y), Serum(x) ADVIA 1650, N 71, Regression Equation Y=0.94X-5.51, Sy.x 5, R 0.993, Sample Range 196-402
    • Heparin Plasma(y), Serum(x) ADVIA 1650, N 72, Regression Equation Y=0.98X-8.45, Sy.x 7.31, R 0.987, Sample Range 196-402
  • Interfering Substances
    • Bilirubin (30 mg/dL), Analyte Conc. 122.5, Effect 0.11, 0.1%
    • Hemoglobin (525 mg/dL), Analyte Conc. 124.6, Effect 1.93, 1.6%
    • Lipids(Trig) (650 mg/dL), Analyte Conc. 132.9, Effect 10.24, 8.4%
    • Bilirubin (30 mg/dL), Analyte Conc. 370.4, Effect 3.43, 0.9%
    • Hemoglobin (525 mg/dL), Analyte Conc. 376.0, Effect 2.16, 0.6%
    • Lipids(Trig) (650 mg/dL), Analyte Conc. 372.7, Effect 1.15, 0.3%
  • Analytical Range: The lowest calibration value of Specific Protein Reference Serum Level 1 to the Transferrin concentration level in Specific Protein Reference Serum Level 5.
  • Expected Values: Males: 215 mg/dL to 365 mg/dL, Females: 250 mg/dL to 380 mg/dL

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.

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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).

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§ 862.1475 Lipoprotein test system.

(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.

0

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
Reagent Part # | Specimen
Type | Predicate Device
Name | Predicate Device
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

1

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
Type | Level | Total
CV% |
|------------------|-------|--------------|
| Serum | 77.6 | 4.5 |
| Serum | 216.4 | 4.1 |

LevelBetween Day CV%
145.35.7

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

Specimen type: SiteComparison System (X)NRegression EquationSyxRSample Range
Serum: ARIBEHRING78$Y=0.70X-1.48$5.490.98648-273
Plasma(y), Serum(x)ADVIA 165072$Y=0.99X-0.38$2.100.99689.7-206.8

Interfering Substances

| Interfering
Substance | Interfering
Sub. Conc.
(mg/dL) | Analyte
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

2

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
Type | Level | Total
CV% |
|------------------|-------|--------------|
| Serum | 29 | 5.7 |
| Serum | 110.5 | 3.3 |

Behring Nephelometer=Serum
LevelBetween Day CV%
1082.4

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

Specimen type: SiteComparison System (X)NRegression EquationSyxRSample Range
Serum: TarrytownBEHRING59Y=1.03X+0.533.660.99342.1-172.8
Plasma(y), Serum(x)ADVIA 165071Y=1.00X-1.671.740.99749.6-157.8

Interfering Substances

| Interfering
Substance | Interfering
Sub. Conc.
(mg/dL) | Analyte
Conc. | Effect
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

3

  1. 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
Type | Level | Total
CV% |
|------------------|-------|--------------|
| Serum | 12.2 | 6.7 |
| Serum | 25.6 | 4.6 |

LevelTotal CV%
13.56.3
23.85.3
27.44.5

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

| Specimen type: Site | Comparison
System (X) | N | Regression
Equation | Syx | R | Sample
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
Substance | Interfering
Sub. Conc.
(mg/dL) | Analyte
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

4

  1. 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
Type | Level | Total
CV% |
|------------------|-------|--------------|
| Serum | 5 | 13.6 |
| Serum | 42 | 4.6 |

Behring Nephelometer=Serum
LevelsBetween Day CV%
10,15,25,45,602.6 to 5.7

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

Specimen type: SiteComparison System (X)NRegression EquationSyx (mg/L)RSample Range (mg/L)
Serum: TarrytownBEHRING56Y=0.96X-3.332.340.9845.4-67.7

Interfering Substances

| Interfering
Substance | Interfering
Sub. Conc.
(mg/dL) | Analyte
Conc. | Effect
Conc. | Effect
% |
|--------------------------|--------------------------------------|------------------|-----------------|-------------|
| 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

5

  1. 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
Type | Level | Total
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 | |

|

----------
1
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00

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

Specimen type: SiteComparison System (x)NRegression EquationSy.x (mg/dL)RSample Range (mg/dL)
Serum: TarrytownBEHRING74$y=1.02X-1.34$14.280.997103-1110
EDTA Plasma(y), Serum(x)ADVIA 165068$y=0.92X+1.48$13.990.98685.7-517.9
Heparin Plasma(y), Serum(x)ADVIA 165069$y=0.97X+2.08$19.420.97582.9-517.9

Interfering Substances

| Interfering
Substance | Interfering
Sub. Conc.
(mg/dL) | Analyte
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

6

  1. 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
Type | Level | Total
CV% |
|------------------|-------|--------------|
| Serum | 926.7 | 2.4 |
| Serum | 2946 | 1.7 |

LevelBetween Day CV%
13172.7

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 | 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
Substance | Interfering
Sub. Conc.
(mg/dL) | Analyte
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

7

  1. 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
Type | Level | Total
CV% |
|------------------|-------|--------------|
| Serum | 54.8 | 7.4 |
| Serum | 172.8 | 3.7 |

LevelBetween Day CV%
1171.9

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

Specimen type: SiteComparison System (x)NRegression EquationSy.x (mg/dL)RSample Range (mg/dL)
Serum: TarrytownBEHRING74y=0.76X+17.97.910.9826.8-300.8
EDTA Plasma(y), Serum(x)ADVIA 165069y=0.99X-4.278.750.98935.6-293.1
Heparin Plasma(y), Serum(x)ADVIA 165070y=0.99X-0.2311.130.98235.6-293.1

Interfering Substances

| Interfering
Substance | Interfering
Sub. Conc.
(mg/dL) | Analyte
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

8

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
Type | Level | Total
CV% |
|------------------|-------|--------------|
| Serum | 193.9 | 4.7 |
| Serum | 473.1 | 3.7 |

LevelBetween Day CV%
3032.3

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

| Specimen type: Site | Comparison
System(X) | N | Regression
Equation | Sy.x | R | Sample
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
Substance | Interfering
Sub. Conc.
(mg/dL) | Analyte
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

10

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

12

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) NumberK992662
--------------------

(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)OROver-The-Counter Use

(Optional Format 1-2-96)

13

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)

14

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 _OROver-The-Counter Use _
(Per 21 CFR 801.109)(Optional Format 1-2-96)