BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Immunohistochemistry Assay, Antibody, Ki-67

    PMA: P210026 · Decision Oct 12, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3

    Basic Information

    Device Name
    Immunohistochemistry Assay, Antibody, Ki-67
    Trade Name
    Ki-67 IHC pharmDx
    PMA Number
    P210026
    Device Class
    FDA Class 3
    Product Code
    QQT
    Generic Name
    Immunohistochemistry assay, antibody, Ki-67
    Medical Specialty
    Unknown
    Advisory Committee
    Pathology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    October 12, 2021
    Date Received
    June 30, 2021
    Expedited Review
    N

    Advisory Committee Statement

    Approval of Ki-67 IHC MIB-1 pharmDx (Dako Omnis)For In Vitro Diagnostic Use.Ki-67 IHC MIB-1 pharmDx (Dako Omnis) is a qualitative immunohistochemical (IHC) assay using monoclonal mouse anti-Ki-67, Clone MIB-1, intended for use in the detection of Ki-67 protein in formalin-fixed, paraffin-embedded (FFPE) breast carcinoma tissue using the EnVision FLEX visualization system on Dako Omnis.Ki-67 protein expression in breast carcinoma is determined by using the Ki-67 pharmDx Score, which is the overall percentage of viable tumor cells in the invasive cancer component showing Ki-67 nuclear staining. The specimen should be considered to have Ki-67 expression if Ki-67 pharmDx Score is ? 20.Ki-67 IHC MIB-1 pharmDx (Dako Omnis) is indicated as an aid in identifying patients with early breast cancer at high risk of disease recurrence for whom adjuvant treatment with Verzenio® (abemaciclib) in combination with endocrine therapy is being considered.

    Classifications

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

    Product Code Device Name
    QQT Immunohistochemistry Assay, Antibody, Ki-67