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510(k) Data Aggregation

    K Number
    K123713
    Device Name
    IMMULISA ENHANCED CELIAC FUSION (TTG/DGP) IGA/IGG ANTIBODY ELISA
    Manufacturer
    IMMCO DIAGNOSTICS, INC.
    Date Cleared
    2013-10-25

    (325 days)

    Product Code
    MVM,MST
    Regulation Number
    866.5660
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of IgA and IgG antibodies to synthetic human tissue transglutaminase (1TG) and deamidated gliadin peptide (DGP) in human serum to aid in the diagnosis of celiae disease (CD) in conjunction with other laboratory tests and clinical findings.

    Device Description

    Enzyme linked immunoassay (ELISA)

    AI/ML Overview

    The provided text details the FDA's clearance of the ImmuLisa Enhanced Celiac Fusion (tTG/DGP) IgA/IgG Antibody ELISA for aiding in the diagnosis of celiac disease. However, the document does not contain specific acceptance criteria or a study summary that details the device's performance against such criteria. The document is primarily an FDA clearance letter and an "Indications for Use" statement.

    Therefore, I cannot provide the requested information from the given text.

    To address the prompt fully, I would need a study report or a different document detailing the performance evaluation of the ImmuLisa Enhanced Celiac Fusion ELISA.

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