BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Test, Her-2/Neu, Ihc

    PMA: P990081 · Supplement: S059 · Decision Dec 15, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    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
    S059
    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
    December 15, 2025
    Date Received
    August 15, 2025
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    This 180-day supplement is to expand labeling of the PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody assay for use as a companion diagnostic to identify patients with HER2-positive, advanced or metastatic breast cancer who may be eligible for treatment with ENHERTU (fam-trastuzumab deruxtecan-nxki) in combination with PERJETA (pertuzumab) as first-line treatment.

    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