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510(k) Data Aggregation

    K Number
    K021398
    Device Name
    APL IGA ELISA KIT
    Date Cleared
    2002-08-27

    (117 days)

    Product Code
    Regulation Number
    866.5660
    Why did this record match?
    Applicant Name (Manufacturer) :

    LOUISVILLE APL DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Antiphospholipid Syndrome is a clinical diagnosis supported by finding a positive antiphospholipid ELISA and/or lupus anticoagulant test. Indications for the test include: patients with unexplained venous thrombosis, particularly if recurrent or at unusual sites as the inferior vena cava or renal veins; unexplained venous thrombosis, particularly if recurrent or at unusual sites as the inferior vena cava or renal veins; unexplained occlusion of the arterial circulation resulting in stroke, myocardial infarction, or peripheral gangrene. In patients with unexplained venous thrombosis, other disorder should be excluded, such as protein C, S, or antithrombin III deficiency, as well as malignancy or the nephrotic syndrome. The test is also indicated in women with one or more unexplained second or third trimester pregnancy losses or two or more first trimester losses. Finally, patients with unexplained thrombocytopenia as well as other abnormalities said to be associated with the Antiphospholipid Syndrome should be tested. The APL® IgA ELISA Kit is a semiquantitative enzyme linked immunosorben assay (ELISA) for use as an aid in diagnosing the Antiphospholipid Syndrome (APS) in patients presenting with thrombosis, pregnancy losses and/or thrombocytopenia. It enables measurement of IgA anticardiolpin antibody levels in human serum.
    Device Description
    Not Found
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    K Number
    K984102
    Device Name
    ACL/APS FACS KIT
    Date Cleared
    1999-03-18

    (121 days)

    Product Code
    Regulation Number
    866.5660
    Why did this record match?
    Applicant Name (Manufacturer) :

    LOUISVILLE APL DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The aCL/aPS®FACS Kit is and assay for the semi-quantitative determination of antiphospholipid (anticardiolipin-aCL and antiphosphatidy/serine-aPS) antibodies to be used in the aid of the diagnosis of the Antiphospholipid Syndrome (APS). APS is defined as a disorder of recurrent thrombosis, pregnancy loss and/or thrombocytopenia with persistent positive antiphospholipid tests.
    Device Description
    ACL/aPS FACS Kit
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