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510(k) Data Aggregation

    K Number
    K992878
    Device Name
    ANTI-TISSUE TRANSGLUTAMINASE (TTG)ANTIBODY TEST
    Manufacturer
    IMMCO DIAGNOSTICS, INC.
    Date Cleared
    1999-10-15

    (50 days)

    Product Code
    MVM
    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

    An enzyme linked immunosorbent assay (ELISA) for the detection and semi-quantitation of anti-tissue Transglutaminase IgA antibodies in human serum to aid in the diagnosis of patients with celiac disease and dermatitis herpetiformis.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter for the ImmuLisa™ Anti-tissue Transglutaminase (tTG) Antibody Test. It does not contain information about acceptance criteria or a study proving the device meets those criteria.

    The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."

    This means the device was cleared based on its substantial equivalence to an existing predicate device, not through a study demonstrating it meets specific acceptance criteria.

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

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