BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer

    PMA: P190031 · Supplement: S015 · Decision May 15, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer
    Trade Name
    HER2 Dual ISH DNA Probe Cocktail
    PMA Number
    P190031
    Supplement Number
    S015
    Device Class
    FDA Class 3
    Product Code
    NYQ
    Generic Name
    Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer
    Medical Specialty
    Unknown
    Advisory Committee
    Pathology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 15, 2026
    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

    Approval to include HER2 Dual ISH DNA Probe Cocktail as a companion diagnostic indication for the determination of HER2 gene amplification status in patients with breast cancer who may benefit from treatment with ENHERTU® (fam-trastuzumab deruxtecan-nxki).

    Classifications

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

    Product Code Device Name
    NYQ Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer