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510(k) Data Aggregation

    K Number
    K964985
    Device Name
    QUANTA LITE IGG GLIADIN ELISA
    Manufacturer
    INOVA DIAGNOSTICS, INC.
    Date Cleared
    1997-05-30

    (168 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

    An Enzyme Linked Immunosorbant Assay (ELISA) for the semiquantitative detection of IgG antibodies to gliadin in human serum. Detection of these antibodies is an aid in diagnosis of certain gluten sensitive enteropathies such as celiac diseage and dermatitis herpetiformis.

    Device Description

    An Enzyme Linked Immunosorbant Assay (ELISA) for the semiquantitative detection of IgG antibodies to gliadin in human serum.

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a diagnostic device, the QUANTA Lite™ IgG Gliadin ELISA Kit. It doesn't contain the detailed study results or acceptance criteria you're asking for. The letter confirms that the device has been found substantially equivalent to a legally marketed predicate device, but it doesn't describe the studies proving its performance or the specific acceptance criteria.

    Therefore, I cannot provide the requested information from this document. The document primarily focuses on the regulatory approval rather than the technical and clinical performance data.

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