BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P150025 · Decision Oct 9, 2015
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    PD-L1 IHC 28-8 pharmDx
    PMA Number
    P150025
    Advisory Committee
    Pathology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    October 9, 2015
    Date Received
    July 9, 2015
    Expedited Review
    N
    Docket Number
    15M-4016

    Advisory Committee Statement

    APPROVAL FOR THE PD-L1 IHC 28-8 PHARMDX. THIS DEVICE IS INDICATED FOR THE FOLLOWING:1) PD-L1 IHC 28-8 PHARMDX IS A QUALITATIVE IMMUNOHISTO-CHEMICAL ASSAY USING MONOCLONAL RABBIT ANTI-PD-L1, CLONE 28-8 INTENDED FOR USE IN THE DETECTION OF PD-L1 PROTEIN IN FORMALIN-FIXED, PARAFFIN-EMBEDDED (FFPE) NON-SQUAMOUS NON-SMALL CELL LUNG CANCER (NSCLC) TISSUE USING ENVISION FLEX VISUALIZATION SYSTEM ON AUTOSTAINER LINK 48; 2) PD-L1 PROTEIN EXPRESSION IS DEFINED AS THE PERCENTAGE OF TUMOR CELLS EXHIBITING POSITIVE MEMBRANE STAINING AT ANY INTENSITY; AND3) PD-L1 EXPRESSION AS DETECTED BY PD-L1 IHC 28-8 PHARMDX IN NON-SQUAMOUS NSCLC MAY BE ASSOCIATED WITH ENHANCED SURVIVAL FROM OPDIVO (NIVOLUMAB).