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510(k) Data Aggregation

    K Number
    K020694
    Device Name
    QAB2A IGM ELISA KIT
    Manufacturer
    CHESHIRE DIAGNOSTICS LTD.
    Date Cleared
    2002-04-19

    (46 days)

    Product Code
    MVS
    Regulation Number
    866.5660
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Product Code :

    MVS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Cheshire Diagnostics Limited QAB2A IgM Elisa Kit is a semi quantitative enzyme linked immunoassay for the detection of the IgM isotype autoantibody to ß2-Glycoprotein-1 in human serum. The presence of ß2-GP1 antibodies can be used in conjunction with other serological tests and clinical findings to aid in the assessment of the risk from thrombosis in patients with Systemic Lupus Erythematosus or other Lupus like disorders.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA for a diagnostic kit (QAB2A IgM Elisa Kit AP). It declares the device substantially equivalent to a predicate device but does not contain information about acceptance criteria or specific study details to prove the device meets such criteria. Therefore, I cannot generate the requested information based on the provided text.

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