BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Test, Her-2/Neu, Ihc

    PMA: P990081 · Supplement: S039 · Decision May 3, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7

    Basic Information

    Device Name
    System, Test, Her-2/Neu, Ihc
    Trade Name
    PATHWAY Anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody
    PMA Number
    P990081
    Supplement Number
    S039
    Device Class
    FDA Class 3
    Product Code
    MVC
    Generic Name
    SYSTEM, TEST, HER-2/NEU, IHC
    Medical Specialty
    Unknown
    Advisory Committee
    Pathology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 3, 2019
    Date Received
    February 13, 2019
    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 Medical Systems, Inc.'s (Ventana) PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody (PATHWAY HER2 (4B5)) is a rabbit monoclonal antibody intended for laboratory use for the semi-quantitative detection of HER2 antigen in sections of formalin-fixed, paraffin-embedded normal and neoplastic tissue following staining on a BenchMark XT or BenchMark ULTRA instrument. It is indicated as an aid in the assessment of breast cancer patients for whom Herceptin® (trastuzumab) or KADCYLA® (ado-trastuzumab emtansine) treatment is being considered.Note: All of the patients in the Herceptin clinical trials were selected using a clinical trial assay. None of the patients in those trials were selected using PATHWAY anti-HER-2/neu (4B5). PATHWAY anti-HER-2/neu (4B5) was compared to PATHWAY HER-2 (clone CB11) Primary Antibody on an independent sample set and found to provide acceptably concordant results. The actual correlation of PATHWAY anti-HER-2/neu (4B5) to clinical outcome has not been established.This product should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information, and proper controls.This antibody 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
    MVC System, Test, Her-2/Neu, Ihc