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510(k) Data Aggregation

    K Number
    K973196
    Device Name
    ZEUS SCIENTIFIC, INC., ANTI-CARDIOLIPIN IGA ELISA REAGENTS
    Manufacturer
    ZEUS SCIENTIFIC, INC.
    Date Cleared
    1997-10-29

    (64 days)

    Product Code
    MID
    Regulation Number
    866.5660
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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. Cardiolipin IgA ELISA test system is an enzyme-linked immunosorbent assay (ELISA) designed for the semiquantitative measurement of circulating IgA autoantibodies to cardiolipin. This test is for in vitro diagnostic use.

    Device Description

    The Zeus Scientific, Inc. Cardiolipin IgA ELISA test system is an enzyme-linked immunosorbent assay (ELISA) designed for the semiquantitative measurement of circulating IgA autoantibodies to cardiolipin.

    AI/ML Overview

    The provided text is related to a 510(k) premarket notification for the Zeus Scientific Inc. Anti-Cardiolipin IgA ELISA Reagents. It primarily details the FDA's approval of the device and its intended use. However, it does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to the questions asked.

    Therefore, I cannot provide the requested information based on the input text.

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