BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

    PMA: P010033 · Supplement: S011 · Decision Oct 10, 2007
    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 IN TUBE
    PMA Number
    P010033
    Supplement Number
    S011
    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
    October 10, 2007
    Date Received
    June 1, 2006
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A MODIFICATION OF THE QUANTIFERON - TB GOLD TO AN IN-TUBE COLLECTION SYSTEM THAT CONSISTS OF THREE BLOOD COLLECTION TUBES, NIL, TB ANTIGEN, AND MITOGEN. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME QUANTIFERON - TB GOLD IN-TUBE AND IS INDICATED FOR USE AS AN IN VITRO DIAGNOSTIC TEST USING A PEPTIDE COCKTAIL SIMULATING ESAT-6, CFP-10 AND TB 7.7(P4) PROTEINS TO STIMULATE CELLS IN HEPARINIZED WHOLE BLOOD DRAWN DIRECTLY INTO SPECIALIZED BLOOD COLLECTION TUBES. DETECTION OF INTERFERON-Y BY ENZYME-LINKED IMMUNOSORBENT ASSAY (ELISA) IS USED TO IDENTIFY IN VITRO RESPONSES TO THESE PEPTIDE ANTIGENS THAT ARE ASSOCIATED WITH MYCOBACTERIUM TUBERCULOSIS INFECTION.

    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