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510(k) Data Aggregation

    K Number
    K032571
    Device Name
    IMMULISA ANTI-HUMAN TISSUE TRANSGLUTAMINASE (HU-TTG) ANTIBODY IGA ELISA
    Manufacturer
    IMMCO DIAGNOSTICS, INC.
    Date Cleared
    2003-12-24

    (126 days)

    Product Code
    MVM
    Regulation Number
    866.5660
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    IMMULISA ANTI-HUMAN TISSUE TRANSGLUTAMINASE (HU-TTG) ANTIBODY IGA ELISA

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

    An enzyme linked immunoassay (ELISA) for the detection and semiquantitation of IgA antibodies to human tissue transglutaminase, as an aid in diagnosing patients with Gluten Sensitive Enteropathy (celiac Disease and Dematitis herpetiformis)

    Device Description

    Not Found

    AI/ML Overview

    This document is a FDA 510(k) clearance letter for the ImmuLisa Anti-human tissue Transglutaminase (human tTG) IgA ELISA device. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The letter confirms that the device is substantially equivalent to a legally marketed predicate device and can be marketed.

    Therefore, I cannot provide the requested information based on the provided text. The document is primarily a regulatory approval notice and does not detail the technical performance evaluation or validation study results.

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