BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Test, Her-2/Neu, Ihc

    PMA: P990081 · Supplement: S055 · Decision Jan 27, 2025
    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
    S055
    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
    January 27, 2025
    Date Received
    August 23, 2024
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N
    Docket Number
    25M-0340

    Advisory Committee Statement

    Approval Order:Approval for the PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody for expanding the indications to include testing for HER2-ultralow (IHC 0 with membrane staining) breast cancer patients who are eligible for treatment with ENHERTU.Intended Use:PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody (PATHWAY anti-HER2 (4B5) antibody) is a rabbit monoclonal antibody intended for laboratory use for the semi-quantitative detection of HER2 antigen by immunohistochemistry (IHC) in sections of formalin-fixed, paraffin-embedded breast carcinoma and biliary tract cancer (gallbladder adenocarcinoma, intrahepatic cholangiocarcinoma, and extrahepatic cholangiocarcinoma) tissue using the ultraView Universal DAB Detection Kit on a BenchMark ULTRA instrument.The IHC device is indicated for identifying patients who are eligible for treatment with the following therapies in accordance with the approved therapeutic labeling:Indications for Use HER2 Score TherapyBreast carcinoma IHC 3+ or IHC 2+/ISH amplified Herceptin®Breast carcinoma IHC 3+ or IHC 2+/ISH amplified KADCYLA®Breast carcinoma IHC 0 with membrane staining, IHC 1+ or IHC 2+/ISH non-amplified ENHERTU®Biliary tract cancer IHC 3+ ZIIHERA®Test results 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