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510(k) Data Aggregation

    K Number
    K052143
    Device Name
    QUANTA LITE GLIADIN IGA II
    Manufacturer
    INOVA DIAGNOSTICS, INC.
    Date Cleared
    2005-10-04

    (57 days)

    Product Code
    MST
    Regulation Number
    866.5750
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Predicate For
    K093459,K113863,K130053,K140691
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The QUANTA Lite™ Gliadin IgA II is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative detection of gliadin IgA antibodies in human serum. The presence of gliadin antibodies can be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of celiac disease.

    Device Description

    The QUANTA Lite™ Gliadin IgA II is an enzyme-linked immunosorbent assay (ELISA).

    AI/ML Overview

    I am sorry, but the provided text does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria, as outlined in your request.

    The document is a 510(k) clearance letter from the FDA for the device "QUANTA Lite™ Gliadin IgA II". It indicates that the device has been found substantially equivalent to a legally marketed predicate device. While it mentions the device's "Indications For Use" and general regulatory requirements, it does not provide any specific acceptance criteria, study performance data, sample sizes, information about ground truth establishment, expert qualifications, or details about comparative effectiveness studies (MRMC) or standalone performance.

    Therefore, I cannot populate the table or answer the specific questions about the study design and results based on the provided text.

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