BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

    PMA: P160002 · Supplement: S009 · Decision Mar 8, 2019
    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
    S009
    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
    March 8, 2019
    Date Received
    September 14, 2018
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N
    Docket Number
    19M-1310

    Advisory Committee Statement

    Approval for VENTANA PD L1 (SP142) Assay is a qualitative immunohistochemical assay using rabbit monoclonal anti-PD L1 clone SP142. The device is intended for use in the assessment of the programmed death-ligand 1 (PD-L1) protein in tumor cells and tumor-infiltrating immune cells in the formalin-fixed, paraffin-embedded (FFPE) tissues indicated below stained with OptiView DAB IHC Detection Kit and OptiView Amplification Kit on a VENTANA BenchMark ULTRA instrument. Determination of PD-L1 status is indication-specific, and evaluation is based on either the proportion of tumor area occupied by PD-L1 expressing tumor-infiltrating immune cells (% IC) of any intensity or the percentage of PD-L1 expressing tumor cells (% TC) of any intensity.VENTANA PD-L1 (SP142) Assay is indicated as an aid for identifying patients for treatment with the therapies for the respective cutoffs listed in Table 1 in accordance with the approved therapeutic product labeling. Table 1. Companion diagnostic indications for the VENTANA PD-L1 (SP142) Assay Indication for use Therapy Cutoff Urothelial Carcinoma TECENTRIQ >= 5% ICTriple-Negative Breast Carcinoma (TNBC) TECENTRIQ >= 1% ICPD-L1 expression in >= 50% TC or >= 10% IC determined by VENTANA PD-L1 (SP142) Assay in non-small cell lung cancer (NSCLC) patients may be associated with enhanced overall survival from TECENTRIQ (atezolizumab).This product should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information, and proper controls. This product is intended for in vitro diagnostic (IVD) use.

    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