BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Test, Her-2/Neu, Ihc

    PMA: P090015 · Decision Apr 18, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7

    Basic Information

    Device Name
    System, Test, Her-2/Neu, Ihc
    Trade Name
    BOND ORACLE HER2 IHC SYSTEM
    PMA Number
    P090015
    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
    April 18, 2012
    Date Received
    July 22, 2009
    Expedited Review
    N
    Docket Number
    12M-0390

    Advisory Committee Statement

    APPROVAL FOR THE BOND ORACLE HER2 IHC SYSTEM. THIS DEVICE IS INDICATED FOR: BOND ORACLE HER2 IHC SYSTEM IS A SEMI-QUANTITATIVE IMMUNOHISTOCHEMICAL (IHC) ASSAY TO DETERMINE HER2 (HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2) ONCOPROTEIN STATUS IN FORMALIN-FIXED, PARRAFIN EMBEDDED BREAST CANCER TISSUE PROCESSED FOR HISTOLOGICAL EVALUATION FOLLOWING AUTOMATED STAINING ON THE BOND-MAX SLIDE STAINING INSTRUMENT. THE BOND ORACLE HER2 IHC SYSTEM IS INDICATED AS AN AID IN THE ASSESSMENT OF PATIENTS FOR WHOM HERCEPTIN (TRASTUZUMAB) TREATMENT IS BEING CONSIDERED.

    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