BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

    PMA: P010033 · Supplement: S006 · Decision Dec 2, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis
    Trade Name
    QUANTIFERON -TB GOLD
    PMA Number
    P010033
    Supplement Number
    S006
    Device Class
    FDA Class 3
    Product Code
    NCD
    Generic Name
    TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
    Medical Specialty
    Unknown
    Advisory Committee
    Microbiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 2, 2004
    Date Received
    December 4, 2003
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE USE OF SYNTHETIC PEPTIDE ANTIGENS ESAT-6 AND CFP-10 AND REMOVAL OF THE TUBERCULIN PPD AND M. AVIUM PPD ANTIGENS USED IN THE QUANTIFERON - TB. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME QUANTIFERON - TB GOLD AND IS INDICATED FOR USE AS AN IN VITRO DIAGNOSTIC TEST USING PEPTIDE COCKTAILS SIMULATING ESAT-6 AND CFP-10 PROTEINS TO STIMULATE CELLS IN HEPARINIZED WHOLE BLOOD. DETECTION OF INTERFERON-Y BY ELISA IS USED TO IDENTIFY IN VITRO RESPONSES TO ESAT-6 AND CFP-10 THAT ARE ASSOCIATED WITH MYCOBACTERIUM TUBERCULOSIS INFECTION. THE DEVICE APPROVAL IS FOR USE OF AN 8-POINT CALIBRATION CURVE WITH MANUAL CALCULATIONS.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NCD Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis