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510(k) Data Aggregation

    K Number
    K981020
    Device Name
    ZEUS ANTI-CARDIOLIPIN IGS ELISA TEST SYSTEM
    Manufacturer
    ZEUS SCIENTIFIC, INC.
    Date Cleared
    1998-05-18

    (60 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. anti-Cardiolipin IgA ELISA Test System is an enzyme-linked immunosorbent assay (ELISA) designed for the semi-quantitative measurement of circulating IgA autoantibodies to cardiolipin. This test is for in vitro diagnostic use.

    Device Description

    The Zeus Scientific, Inc. anti-Cardiolipin IgA ELISA Test System is an enzyme-linked immunosorbent assay (ELISA) designed for the semi-quantitative measurement of circulating IgA autoantibodies to cardiolipin.

    AI/ML Overview

    This is a letter acknowledging the receipt of a 510(k) premarket notification for a medical device and determining its substantial equivalence to previously marketed devices. It does not contain the specific acceptance criteria or study details requested. Therefore, I cannot extract the information to fill the table and answer the questions.

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