LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K971784

    Validate with FDA (Live)

    Device Name
    ZEUS SCIENTIFIC, INC., ANTICARDIOLIPIN IGG/IGM ELISA TEST SYSTEM
    Manufacturer
    ZEUS SCIENTIFIC, INC.
    Date Cleared
    1997-07-23

    (70 days)

    Product Code
    MID
    Regulation Number
    866.5660
    Type
    Traditional
    Panel
    Immunology
    Age Range
    All
    Reference & Predicate Devices
    N/A
    Predicate For
    K981351
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis 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 IgG/IgM ELISA test system is an enzyme-linked immunosorbent assay (ELISA) designed for the semi-quantitative measurement of circulating IgG and IgM autoantibodies to cardiolipin. This test is for in vitro diagnostic use.

    Device Description

    The Zeus Scientific, Inc. Cardiolipin IgG/IgM ELISA test system is an enzyme-linked immunosorbent assay (ELISA) designed for the semi-quantitative measurement of circulating IgG and IgM autoantibodies to cardiolipin.

    AI/ML Overview

    The provided text is related to a 510(k) clearance letter for a medical device called the "Anti-Cardiolipin IgG/IgM Test System." This document grants market clearance based on substantial equivalence to a predicate device and outlines the intended use. However, it does not include the detailed study results, acceptance criteria, or performance data that would typically be required to answer your specific questions about device performance and validation.

    Therefore, I cannot provide the information requested in your prompt based on the provided text. The document is an FDA clearance letter, not a technical report detailing the device's performance study.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1