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510(k) Data Aggregation

    K Number
    K063818
    Device Name
    QUANTA PLEX CELIAC IGA PROFILE
    Manufacturer
    INOVA DIAGNOSTICS, INC.
    Date Cleared
    2007-06-20

    (180 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

    The QUANTA Plex™ Celiac IgA Profile is a fluorescent immunoassay for the semi-quantitative detection of IgA anti-human tissue transglutaminase (htTG) and antideamidated gliadin peptide (DGP) antibodies, and the detection of an insufficient amount of IgA, in human serum. The presence of these antibodies in conjunction with other laboratory and clinical findings is an aid in the diagnosis of the gluten sensitive enteropathy celiac disease. Insufficient IgA indicates that there is not enough IgA to allow detection of IgA anti-htTG or anti-DGP.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is an FDA 510(k) clearance letter and does not contain the specific information requested regarding the acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment for a device. The document primarily focuses on the regulatory clearance of the QUANTA Plex™ Celiac IgA Profile and its indications for use, stating that it has been deemed "substantially equivalent" to legally marketed predicate devices.

    Therefore, I cannot extract the requested information from this document.

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