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510(k) Data Aggregation

    K Number
    K070083
    Device Name
    QUANTA LITE H-TTG/DGP SCREEN
    Manufacturer
    INOVA DIAGNOSTICS, INC.
    Date Cleared
    2007-03-12

    (62 days)

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

    QUANTA Lite™ h-tTG/DGP Screen is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative detection of IgA and IgG antibodies to synthetic, deamidated gliadin-derived peptides and human tissue transglutaminase (h-tTG) [endomysium] in human serum. The presence of these antibodies can be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of both IgA sufficient and IgA deficient celiac disease.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA for a device called "QUANTA Lite™ h-tTG/DGP Screen." It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information about acceptance criteria, device performance, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/ML device study.

    The document is for an in vitro diagnostic (IVD) device which is an ELISA kit for detecting antibodies. It's a traditional laboratory test, not an AI/ML powered device. Therefore, the questions posed regarding AI/ML study specifics are not applicable to the provided text.

    To address the prompt, I would need a document describing the study of an AI/ML device, including performance metrics, test sets, and ground truth methodologies.

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