THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGM ELISA TEST SYSTEM

K984175 · Zeus Scientific, Inc. · MID · Dec 17, 1998 · Immunology

Device Facts

• Record ID: K984175
• Device Name: THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGM ELISA TEST SYSTEM
• Applicant: Zeus Scientific, Inc.
• Product Code: MID · Immunology
• Decision Date: Dec 17, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5660
• Device Class: Class 2

Intended Use

Autoantibodies directed against phospholipids, and anti-cardiolipin (aCL) in particular, have been associated with recurrent thrombosis, thrombocytopenia, and spontaneous abortions. Detection of these autoantibodies may aid in the diagnosis of such disorders. The Zeus Scientific, Inc. anti-Cardiolipin IgM ELISA Test System is an automated or manually operated enzyme-linked immunosorbent assay (ELISA) designed for the semi-quantitative measurement of circulating IgM autoantibodies to cardiolipin. This test is for in vitro diagnostic use.

Device Story

The Zeus Scientific Anti-Cardiolipin IgM ELISA Test System is an in vitro diagnostic assay for detecting IgM autoantibodies to cardiolipin. The device utilizes enzyme-linked immunosorbent assay (ELISA) technology; it can be performed manually or via automated systems. The test processes patient serum samples to measure autoantibody levels, which are associated with clinical conditions including recurrent thrombosis, thrombocytopenia, and spontaneous abortions. Healthcare providers use the semi-quantitative results to assist in the diagnosis of these disorders. The device is intended for professional use in clinical laboratory settings.

Clinical Evidence

No clinical data provided in the document; substantial equivalence is based on technological and intended use characteristics.

Technological Characteristics

Enzyme-linked immunosorbent assay (ELISA) for semi-quantitative detection of IgM autoantibodies. The system is designed for both manual and automated operation.

Indications for Use

Indicated for the semi-quantitative measurement of circulating IgM autoantibodies to cardiolipin in human serum to aid in the diagnosis of disorders associated with recurrent thrombosis, thrombocytopenia, and spontaneous abortions.

Regulatory Classification

Identification

A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).

Submission Summary (Full Text)

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DEC 17 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Mark J. Kopnitsky Vice President, Research & Development Zeus Scientific, Inc. 200 Evans Way Branchburg, New Jersey 08876

K984175 Re: Aptus (Automated) Application for the Anti-Trade Name: Cardiolipin IgM ELISA Test System Requlatory Class: II Product Code: MID Dated: November 18, 1998 Received: November 20, 1998

Dear Mr. Kopnitsky:

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 Requlations, 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 Requlation (QS) for Medical Devices: General requlation (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 requlatory 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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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 Butman

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): ¥98 4175

Aptus (automated) Application for the Anti-Cardiolipin IgM Device Name: ELISA Test System

Indications for Use:

Autoantibodies directed against phospholipids, and anti-cardiolipin (aCL) in particular, have been associated with recurrent thrombosis, thrombocytopenia, and spontaneous abortions. Detection of these autoantibodies may aid in the diagnosis of such disorders. The Zeus Scientific, Inc. anti-Cardiolipin IgM ELISA Test System is an automated or manually operated enzyme-linked immunosorbent assay (ELISA) designed for the semi-quantitative measurement of circulating IgM autoantibodies to cardiolipin. This test is for in vitro diagnostic use.

Peter E. Mofiem

(Division Sign-Off) ion of Clinical Laboratory Devi 510(k) Number

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use √

OR

Over-The-Counter Use

(Per 21 CFR 801,109)

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