BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase

    PMA: P140025 · Supplement: S006 · Decision Nov 6, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase
    Trade Name
    VENTANA ALK (D5F3) CDx Assay
    PMA Number
    P140025
    Supplement Number
    S006
    Device Class
    FDA Class 3
    Product Code
    PKW
    Generic Name
    Immunohistochemistry assay, antibody, anaplastic lymphoma kinase
    Medical Specialty
    Unknown
    Advisory Committee
    Pathology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    November 6, 2017
    Date Received
    June 7, 2017
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the VENTANA ALK (D5F3) CDx Assay. The device is intended for the qualitative detection of the anaplastic lymphoma kinase (ALK) protein in formalin-fixed, paraffin-embedded (FFPE) non-small cell lung carcinoma (NSCLC) tissue stained with a BenchMark XT or BenchMark ULTRA automated staining instrument. It is indicated as an aid in identifying patients eligible for treatment with XALKORI® (crizotinib) or ZYKADIA® (ceritinib) or ALECENSA® (alectinib).

    Classifications

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

    Product Code Device Name
    PKW Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase