BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Test, Her-2/Neu, Ihc

    PMA: P990081 · Supplement: S003 · Decision Jan 11, 2007
    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) PRIMARY ANTIBODY
    PMA Number
    P990081
    Supplement Number
    S003
    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 11, 2007
    Date Received
    May 4, 2006
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MODIFICATIONS TO THE PATHWAY C-ERBB-2 PRIMARY ANTIBODY(CLONE CB11) WHICH INCLUDE 1) CHANGE THE PRIMARY ANTIBODY FROM THE MOUSE MONOCLONAL ANTIBODY CB11 TO THE RABBIT MONOCLONAL ANTIBODY 4B5, 2) CHANGE THE DETECTION FORMAT FROM BASIC DAB DETECTION KIT TO THE VENTANA MEDICAL SYSTEMS IVIEW DAB DETECTION KIT, 3) ADD THE OPTIONAL ULTRAVIEW UNIVERSAL DAB DETECTION KIT FOR BIOTIN FREE DETECTION FORMAT, 4) CONSOLIDATE LEVEL 1,3 AND NEGATIVE HER-2 ASSAY CONTROL SLIDES ONTO A SINGLE SLIDE AND ADD A LEVEL 2 ASSAY CONTROL AND THE CONTROL WILL BE MARKETED UNDER THE TRADE NAME OF PATHWAY HER2 4 IN 1 CONTROL SLIDE, AND 5) INCLUDE THE VENTANA IMAGE ANALYSIS SYSTEM (VIAS) IN THE LABELING. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PATHWAY ANTI-HER-2/NEU (4B5) PRIMARY ANTIBODY AND IS INDICATED FOR: VENTANA MEDICAL SYSTEMS, INC.?S (VENTANA) PATHWAY ANTI-HER-2/NEU (4B5) 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 ON A VENTANA AUTOMATED IMMUNOHISTOCHEMISTRY SLIDE STAINING DEVICE. IT IS INDICATED AS AN AID IN THE ASSESSMENT OF BREAST CANCER PATIENTS FOR WHOM HERCEPTIN 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