BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

    PMA: P180047 · Decision Nov 26, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis
    Trade Name
    LIAISON QuantiFERON - TB Gold Plus, LIAISON Control QuantiFERON - TB Gold Plus and LIAISON QuantiFERON Software
    PMA Number
    P180047
    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
    November 26, 2019
    Date Received
    December 10, 2018
    Expedited Review
    N
    Docket Number
    19M-5683

    Advisory Committee Statement

    Approval for the LIAISON QuantiFERON-TB Gold Plus assay, the LIAISON Control QuantiERON-TB Gold Plus, and the LIAISON QuantiFERON Software.The LIAISON QuantiFERON-TB Gold Plus assay is an in vitro diagnostic test intended for the detection of interferon-y (IFN-y) in human lithium heparin plasma by chemiluminescence immunoassay (CLIA) using the LIAISON XL Analyzer. QIAGEN QuantiFERON-TB Gold Plus Blood Collection Tubes, containing a peptide cocktail simulating ESAT-6, and CFP-10 proteins, are used in conjunction with the LIAISON QuantiFERON-TB Gold Plus assay to stimulate cells in heparinized whole blood. Detection of IFN-y is used to identify in vitro responses to these peptide antigens that are associated with Mycobacterium tuberculosis infection.The assay is a qualitative indirect test for M. tuberculosis infection (including disease) and is intended for use in conjunction with risk assessment, radiography, and other medical and diagnostic evaluations to assist the clinician in making individual patient management decisions. The LIAISON QuantiFERON-TB Gold Plus assay must be performed using the LIAISON XL Analyzer.The LIAISON Control QuantiFERON-TB Gold Plus is intended for use as assayed quality control samples to monitor the performance of the LIAISON QuantiFERON-TB Gold Plus assay. The performance characteristics of LIAISON Control QuantiFERON-TB Gold Plus have not been established for any other assays or instrument platforms other than the LIAISON XL Analyzer.The LIAISON QuantiFERON Software (LQS) is optional software intended to analyze the data generated by the LIAISON QuantiFERON-TB Gold Plus assay on the LIAISON XL Analyzer. LQS reports assay results as positive, negative, or indeterminate by an algorithm that combines the individual results associated with the four QIAGEN QuantiFERON-TB Gold Plus Blood Collection Tubes into a final result.

    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