ADVIA IMS DIRECT HDL CHOLESTEROL ASSAY

K050632 · Bayer Healthcare, LLC · LBS · May 26, 2005 · Clinical Chemistry

Device Facts

• Record ID: K050632
• Device Name: ADVIA IMS DIRECT HDL CHOLESTEROL ASSAY
• Applicant: Bayer Healthcare, LLC
• Product Code: LBS · Clinical Chemistry
• Decision Date: May 26, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1475
• Device Class: Class 1

Intended Use

This in vitro method is intended to quantitatively measure HDL Cholesterol in human serum and plasma on the Bayer ADVIA® IMS systems. Measurements of HDL Cholesterol are used in assessing cardiovascular risk.

Device Story

The Bayer ADVIA IMS Direct HDL Cholesterol Assay is an immunoturbidometric in vitro diagnostic test used on the Bayer ADVIA IMS Analyzer. It processes human serum or plasma samples to quantify HDL cholesterol levels. The assay utilizes two premixed liquid reagents (R1 and R2) loaded directly onto the analyzer. The system performs an automated reaction sequence involving sample incubation and measurement of turbidity changes. The resulting HDL cholesterol concentration is used by clinicians to assess cardiovascular disease risk. The device is intended for professional use in clinical laboratory settings.

Clinical Evidence

Bench testing only. Precision studies (N=40 per level) showed within-run CVs of 1.3-3.0% and total CVs of 1.8-3.3%. Linearity was established from 7-90 mg/dL (r=0.9987). Method comparison against the predicate (ADVIA 1650) yielded r=0.988. Interference testing confirmed no significant deviation (≤10%) with bilirubin (up to 30 mg/dL conjugated/20 mg/dL unconjugated), hemoglobin (500 mg/dL), and lipids (1000 mg/dL). Matrix comparison confirmed equivalency between serum, lithium heparin plasma, and potassium-EDTA plasma.

Technological Characteristics

In vitro diagnostic reagent system for automated chemistry analyzers. Quantitative colorimetric/enzymatic assay principle. Analytical range: 7-90 mg/dL. Designed for use on Bayer ADVIA IMS platform. No specific materials or software algorithms described beyond standard automated clinical chemistry instrumentation.

Indications for Use

Indicated for in vitro diagnostic measurement of HDL cholesterol in human serum and plasma for cardiovascular disease risk assessment. For professional use only.

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

• Bayer ADVIA Chemistry Direct HDL Cholesterol Assay (k982341)

Submission Summary (Full Text)

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MAY 2 6 2005

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Direct HDL Cholesterol Method for ADVIA® Modular System (IMS) ™

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92.

The assigned 510(k) number is: Koso6 3 2

### 1. Intended Use

This in vitro method is intended to quantitatively measure HDL Cholesterol in human serum and plasma on the Bayer ADVIA® IMS systems. Measurements of HDL Cholesterol are used in assessing cardiovascular risk.

#### Predicate Device 2.

| Product Name | Reagent Part # | Calibrator Part # |
|------------------------|----------------|-------------------|
| Bayer ADVIA 1650 | 08058065 | 00309530 |
| Direct HDL Cholesterol | | (B03-4763-01) |

#### Device / Method 3.

| Product Name | Reagent Part # | Calibrator Part # |
|------------------------|----------------|-------------------|
| ADVIA IMS | 07986694 | 00309530 |
| Direct HDL Cholesterol | | (B03-4763-01) |

#### Performance 4.

### A. Imprecision

| ADVIA IMS | ADVIA 1650 | | |
|-------------|--------------|-------------|-------------|
| Level mg/dL | Total CV (%) | Level mg/dL | Total CV(%) |
| 37.04 | 3.3 | 36.15 | 2.6 |
| 54.84 | 1.9 | 55.00 | 1.9 |
| 82.55 | 1.8 | 76.92 | 1.9 |

### C. Correlation (Y=ADVIA IMS, X = Comparison system)

| Specimen type | Comparison<br>System (X) | N | Regression<br>Equation | Syx<br>mg/dL | R | IMS Sample<br>Range<br>mg/dL |
|---------------|--------------------------|-----|------------------------|--------------|-------|------------------------------|
| Serum | ADVIA 1650 | 100 | $Y=0.986X+1.16$ | 2.29 | 0.988 | 15 to 88 |

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# D. Interfering Substances

| Interfering<br>Substance | Interfering Sub.<br>Conc. (mg/dL) | HDL Cholesterol<br>Concentration<br>(mg/dL) | Effect<br>(% change) |
|-----------------------------|-----------------------------------|---------------------------------------------|----------------------|
| Bilirubin<br>(unconjugated) | 30 | 44.3 | -1.1% |
| Bilirubin<br>(conjugated) | 20 | 46.5 | -7.3% |
| Hemoglobin | 500 | 46.2 | -9.5% |
| Lipids (Intralipid) | 1000 | 45.0 | -4.9% |

# E. Analytical Range

7 to 90 mg/dL.

Re h 3/4/2005

Date

Andres Holle Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York, 10591 - 5097

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement. The text is in all capital letters and is positioned around the upper half of the circular logo.

Public Health Service

Food and Drug Administrati 2098 Gaither Road Rockville MD 20850

MAY 2 6 2005

Mr. Andres Holle Manager, Regulatory Affairs Bayer HealthCare Diagnostics Division 511 Benedict Avenue Tarrytown, NY 10591

Re: k050632

Trade/Device Name: Direct HDL Cholesterol for the ADVIA IMS Regulation Number: 21 CFR 862.1475 Regulation Name: Lipoprotein test system Regulatory Class: Class I Product Code: LBS Dated: March 4, 2005 Received: March 9, 2005

Dear Mr. Holle:

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 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) that do not require approval of a premarket approval application (PMA). 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin 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 information about the application of labeling requirements to your device. or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Carol C. Benem

Carol C. Benson, M.A. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications for Use

KOS 063 2 510(k) Number:

Device Name: Direct HDL Cholesterol for the ADVIA IMS

Indications for Use:

The Bayer ADV/A IMS Direct HDL Cholesterol (D-HDL) method is for in vitro diagnostic use to measure HDL Cholesterol in human serum and plasma. Such measurements are used in the risk assessment of cardiovascular diseases.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Ruta Chester

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

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KO50632 510(k)