BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

    PMA: P150013 · Decision Oct 2, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1
    Trade Name
    PD-L1 IHC 22C3 PHARMDX
    PMA Number
    P150013
    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
    October 2, 2015
    Date Received
    April 6, 2015
    Expedited Review
    Y
    Docket Number
    15M-3520

    Advisory Committee Statement

    APPROVAL FOR THE PD-L1 IHC 22C3 PHARMDX. THIS DEVICE IS INDICATED FOR THE FOLLOWING: PD-L1 IHC 22C3 PHARMDX IS A QUALITATIVE IMMUNOHISTOCHEMICAL ASSAY USING MONOCLONAL MOUSE ANTI-PD-L1, CLONE 22C3 ANTIBODY INTENDED FOR USE IN THE DETECTION OF PD-L1PROTEIN IN FORMALIN FIXED, PARAFFIN EMBEDDED (FFPE) NON-SMALL CELL LUNG CANCER (NSCLC) TISSUE USING ENVISION FLEX VISUALIZATION SYSTEM ON AUTOSTAINER LINK 48. PD-L1 PROTEIN EXPRESSION IS DETERMINED BY USING TUMOR PROPORTION SCORE (TPS), WHICH IS THE PERCENTAGE OF VIABLE TUMOR CELLS SHOWING PARTIAL OR COMPLETE MEMBRANE STAINING. THE SPECIMEN SHOULD BE CONSIDERED PD-L1 POSITIVE IF TPS >= 50% OF THE VIABLE TUMOR CELLS EXHIBIT MEMBRANE STAINING AT ANY INTENSITY. PD-L1 IHC 22C3 PHARMDX IS INDICATED AS AN AID IN IDENTIFYING NSCLC PATIENTS FOR TREATMENT WITH KEYTRUDA (PEMBROLIZUMAB).

    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