THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (F

K984347 · Zeus Scientific, Inc. · MID · Dec 17, 1998 · Immunology

Device Facts

• Record ID: K984347
• Device Name: THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (F
• 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 IgG ELISA Test System is an automated or manually operated enzyme-linked immunosorbent assay (ELISA) designed for the semi-quantitative measurement of circulating IgG autoantibodies to cardiolipin. This test is for in vitro diagnostic use.

Device Story

In vitro diagnostic ELISA test system; detects circulating IgG autoantibodies to cardiolipin. Input: patient serum/plasma samples. Principle: enzyme-linked immunosorbent assay (ELISA) using cardiolipin-coated wells; patient antibodies bind to antigen; enzyme-conjugated secondary antibody added; substrate reaction produces colorimetric signal proportional to antibody concentration. Operation: automated or manual; performed by laboratory personnel in clinical settings. Output: semi-quantitative measurement of IgG autoantibodies. Clinical utility: aids in diagnosis of conditions associated with antiphospholipid syndrome, including recurrent thrombosis, thrombocytopenia, and spontaneous abortions.

Clinical Evidence

No clinical data provided in the summary document; substantial equivalence based on technological and performance characteristics of the ELISA methodology.

Technological Characteristics

Enzyme-linked immunosorbent assay (ELISA) system; cardiolipin-coated microtiter plates; colorimetric detection; semi-quantitative measurement; automated or manual operation.

Indications for Use

Indicated for semi-quantitative measurement of circulating IgG autoantibodies to cardiolipin in patients suspected of having 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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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 17 1998

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

K984347 Re: Aptus (Automated) Application for the Anti-Trade Name: Cardiolipin IgG ELISA Test System II Regulatory Class: Product Code: MID Dated: December 3, 1998 Received: December 4, 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 Regulations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. 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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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 diaqnostic 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 Autman

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): 长984 347

Aptus (automated) Application for the Anti-Cardiolipin IgG 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 IgG ELISA Test System is an automated or manually operated enzyme-linked immunosorbent assay (ELISA) designed for the semi-quantitative measurement of circulating IgG autoantibodies to cardiolipin. This test is for in vitro diagnostic use.

Peter E. Molson

al Laboratory Devi

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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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