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510(k) Data Aggregation

    K Number
    K984137
    Device Name
    QUANTA LITE CELIAC SCREEN (TISSUE TRANSGLUTAMINASE/GLIADIN) ELISA
    Manufacturer
    INOVA DIAGNOSTICS, INC.
    Date Cleared
    1999-01-28

    (71 days)

    Product Code
    MVM
    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

    Linked Immunosorbant Assay (ELISA) for An the Enzyme nonquantitative detection of IgA antibodies to tissue transglutaminase (tTG) and gliadin in human serum. Detection of these antibodies is an aid in diagnosis of certain gluten sensitive enteropathies such as celiac disease and dermatitis herpetiformis.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) approval letter from the FDA for the QUANTA Lite™ Celiac Screen ELISA. It primarily concerns regulatory approval and does not contain the detailed study information required to answer the requested questions about acceptance criteria, device performance, sample sizes, ground truth establishment, or specific study designs (like MRMC or standalone).

    Therefore, I cannot provide the requested table and detailed information based solely on the provided text. The document confirms the device's substantial equivalence to a legally marketed predicate device and allows it to be marketed, but it does not include the underlying performance studies or their methodologies.

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