BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

    PMA: P160002 · Supplement: S012 · Decision May 18, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1
    Trade Name
    Ventana PD-L1 (SP142) Assay
    PMA Number
    P160002
    Supplement Number
    S012
    Device Class
    FDA Class 3
    Product Code
    PLS
    Generic Name
    Immunohistochemistry assay, antibody, programmed death-ligand 1
    Medical Specialty
    Unknown
    Advisory Committee
    Pathology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 18, 2020
    Date Received
    January 21, 2020
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval of the VENTANA PD-L1 (SP142) Assay as a companion diagnostic for identifying patients with non-small cell lung carcinoma (NSCLC) with PD-L1 expression in TC >= 50% or IC >= 10% for treatment with TECENTRIQ based upon the IMpower110 clinical study.

    Classifications

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

    Product Code Device Name
    PLS Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1