LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K062708
    Device Name
    QUANTA LITE CELIAC DGP SCREEN
    Manufacturer
    INOVA DIAGNOSTICS, INC.
    Date Cleared
    2006-12-13

    (93 days)

    Product Code
    MST
    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™ Celiac 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 in human serum. The presence of these deamidated peptide 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 as well as dermatitis herpetiformis.

    Device Description

    Not Found

    AI/ML Overview

    This letter from the FDA is an approval for a medical device (QUANTA Lite™ Celiac DGP Screen) but does not contain the detailed study information regarding acceptance criteria and performance you've requested. It primarily establishes substantial equivalence to a legally marketed predicate device.

    To provide the requested information, I would need access to the actual 510(k) premarket notification (K062708) submission for the QUANTA Lite™ Celiac DGP Screen, which would typically include detailed clinical and analytical performance studies. The document provided is the FDA's decision letter based on their review of that submission.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1