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    K Number
    K964344
    Device Name
    IGG ANTI-GLIADIN (IGG-AGA) ANTIBODY TEST KIT
    Manufacturer
    IMMCO DIAGNOSTICS, INC.
    Date Cleared
    1997-05-30

    (211 days)

    Product Code
    MST
    Regulation Number
    866.5750
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    IGG ANTI-GLIADIN (IGG-AGA) ANTIBODY TEST KIT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    An enzyme linked immunosorbent assay (ELISA) for the detection and semiquantitation of IgG anti-gliadin antibodies in human serum to aid in the diagnosis of patients with celiac disease and dermatitis herpetiformis.

    Device Description

    Not Found

    AI/ML Overview

    The provided text mentions the "IgG Anti-Gliadin (IgG-AGA) Antibody Test Kit" and its intended use for diagnosing patients with celiac disease and dermatitis herpetiformis. It is a 510(k) clearance document, which means the device demonstrates substantial equivalence to a predicate device. However, this document does not contain details about specific acceptance criteria or a study proving the device meets those criteria.

    Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth establishment, or clinical study designs (MRMC, standalone) based solely on the provided text. This information would typically be found in the 510(k) summary or the full submission, which is not included here.

    The document primarily focuses on the FDA's decision regarding substantial equivalence for marketing purposes.

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