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    K Number
    K091522
    Device Name
    IMMULISA CELIAC G+ (GLIADIN) IGA AND IGG ANTIBODY ELISA
    Manufacturer
    IMMCO DIAGNOSTICS, INC.
    Date Cleared
    2010-02-04

    (258 days)

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

    IMMULISA CELIAC G+ (GLIADIN) IGA AND IGG ANTIBODY ELISA

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

    Enzyme linked immunosorbent assay (ELISA) for the qualitative and semi-quantitative detection of IgA or IgG antibodies to qliadin in human serum to aid in the diagnosis of celiac disease in conjunction with other laboratory and clinical findings.

    Device Description

    Not Found

    AI/ML Overview

    This is a 510(k) premarket notification for an immunoassay device (ImmuLisa Celiac G+ (Gliadin) IgA and IgG Antibody ELISA) and not an AI/ML device. Therefore, the provided document does not contain the specific information required to answer the prompt regarding AI/ML device acceptance criteria and study details.

    The document discusses the substantial equivalence determination for a laboratory diagnostic test. It outlines the regulatory classification, product codes, and general controls for such devices, but it does not detail performance studies in the context of AI/ML algorithms.

    Therefore, I cannot extract the requested information from this document.

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