APOLIPOPROTEIN A1

K983289 · Abbott Laboratories · DER · Jan 29, 1999 · Immunology

Device Facts

• Record ID: K983289
• Device Name: APOLIPOPROTEIN A1
• Applicant: Abbott Laboratories
• Product Code: DER · Immunology
• Decision Date: Jan 29, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5580
• Device Class: Class 2

Intended Use

The Apolipoprotein A1 assay is used for the quantitation of apolipoprotein A1 in human serum or plasma. Measurement of A lipoproteins, the major proteins found in HDL (high density lipoprotein), is used in the diagnosis and treatment of premature coronary artery disease, hyper-a-lipoproteinemia, and hypo-α-lipoproteinemia.

Device Story

In vitro diagnostic assay for quantitative determination of apolipoprotein A1 in human serum or plasma; utilizes antibodies to form insoluble immune complexes with apolipoprotein A1 in sample; immune complexes increase sample turbidity; turbidity measured at 804 nm via AEROSET System; light scattering intensity directly proportional to apolipoprotein A1 concentration; used in clinical laboratory settings by trained personnel; results assist clinicians in diagnosing and managing coronary artery disease and lipoprotein disorders.

Clinical Evidence

Bench testing only. Method comparison study performed on AEROSET System vs. predicate (Hitachi 717 Analyzer). Results: correlation coefficient 0.9919, slope 0.976, Y-intercept 6.236 mg/dL. Precision studies (within-run, between-run, between-day) showed total %CV of 2.1% for both control levels. Assay range up to 464 mg/dL; limit of quantitation 0.525 mg/dL.

Technological Characteristics

In vitro immunoturbidimetric assay. Measures turbidity at 804 nm. Reagents include antibodies specific to apolipoprotein A1. Designed for use on automated clinical chemistry analyzers (AEROSET System).

Indications for Use

Indicated for the quantitative determination of apolipoprotein A1 in human serum or plasma to aid in the diagnosis and treatment of premature coronary artery disease, hyper-a-lipoproteinemia, and hypo-α-lipoproteinemia.

Regulatory Classification

Identification

An alpha-1-lipoprotein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the alpha-1-lipoprotein (high-density lipoprotein) in serum and plasma. Measurement of alpha-1-lipoprotein may aid in the diagnosis of Tangier disease (a hereditary disorder of fat metabolism).

Predicate Devices

• K-ASSAY® Apo A1 (K964292)

Submission Summary (Full Text)

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JAN 2 9 1399

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Section II

510(k) Summary

Apolipoprotein A1 510(k)
September 17. 1998
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Section II

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# 510(k) Summary

#### Submitter's Name/Address Contact Person Abbott Laboratories Linda Morris Senior Regulatory Specialist MS 1-8 1920 Hurd Drive Irving, Texas 75038 Regulatory Affairs [phone] Fax [phone]

| Date of Preparation of this Summary: | Month, 1998 |
|--------------------------------------------------|-------------------|
| Device Trade or Proprietary Name: | ApoA |
| Device Common/Usual Name or Classification Name: | Apolipoprotein A1 |
| Classification Number/Class: | Class II |

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

The assigned 510(k) number is: _ (4832 89

## Test Description:

Apolipoprotein A1 is an in vitro diagnostic assay for the quantitative determination of apolipoprotein A1 in human serum or plasma. Antibodies to apolipoprotein A1 combine with apolipoprotein A1 in the sample to form insoluble immune complexes. The immune complexes cause an increase in light scattering (turbidity). The resulting increase in sample turbidity, measured at 804 nm, is directly proportional to the concentration of apolipoprotein A1 in the sample.

## Substantial Equivalence:

The Apolipoprotein A1 assay is substantially equivalent to the K-ASSAY® Apo A1 (K964292) on the Hitachi® 717 Analyzer.

Apolipoprotein A1 510(k) September 17, 1998 ApoA_VI.Iwp

Section II Page 1

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Both assays yield similar Performance Characteristics.

Similarities:

- . Both assays are in vitro immunoassay methods.
- Both assays can be used for the quantitative determination of apolipoprotein A1. .
- . Both assays vield similar clinical results.
- . Both assays are based on the formation of immune complexes.

Differences:

- There is a difference between the assay range. .
### Intended Use:

The Apolipoprotein A1 assay is used for the quantitation of apolipoprotein A1 in human serum or plasma.

## Performance Characteristics:

Comparative performance studies were conducted using the AEROSET™ System. The Apolipoprotein A1 assay method comparison yielded acceptable correlation with the K-ASSAY Apo A1 on the Hitachi 717 Analyzer. The correlation coefficient = 0.9919, slope = 0.976, and Y-intercept = 6.236 mg/dL. Precision studies were conducted using the Apolipoprotein A1 assay. Within-run, between-run, and between-day studies were performed using two levels of control material. The total %CV for Level 1/Panel 401 is 2.1% and Level 2/Panel 402 is 2.1%. The Apolipoprotein A1 assay range is up to 464 mg/dL. The limit of quantitation (sensitivity) for the Apolipoprotein A1 assay is 0.525 mg/dL. These data demonstrate that the performance of the Apolipoprotein A1 assay is substantially equivalent to the performance of the K-ASSAY Apo A1 on the Hitachi 717 Analyzer.

Apolipoprotein A1 510(k) September 17, 1998 ADOA VI.Iwn

Section II Page 2

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## Conclusion:

The Apolipoprotein A1 assay is substantially equivalent to the K-ASSAY Apo A1 on the Hitachi 717 Analyzer as demonstrated by results obtained in the studies.

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Apolipoprotein A1 510(k) September 17. 1998 ApoA_V1.lwp

Section II Page 3

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Public Health Service

Image /page/4/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle with three wing-like shapes, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle symbol.

JAN 29 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Linda Morris Senior Regulatory Specialist Abbott Laboratories 1920 Hurd Drive Irving, Texas 75038

Re: K983289 Trade Name: AEROSET Apolipoprotein A1 Regulatory Class: II Product Code: DER Dated: December 3, 1998 Received: December 4, 1998

## Dear Ms. Morris:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D, M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): ---

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The Apolipoprotein A1 assay is used for the quantitation of apolipoprotein A1 in human serum or plasma. Measurement of A lipoproteins, the major proteins found in HDL (high density lipoprotein), is used in the diagnosis and treatment of premature coronary artery disease, hyper-a-lipoproteinemia, and hypo-α-lipoproteinemia.

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Concurrence of CDRH, Office of Device Evaluation (ODE) Over-The-Counter Use Prescription Use V OR (Per 21 CFR 801.109)

(Optional Format 1-2-96)

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