BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Test, Her-2/Neu, Ihc

    PMA: P990081 · Supplement: S002 · Decision Oct 21, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7

    Basic Information

    Device Name
    System, Test, Her-2/Neu, Ihc
    Trade Name
    PATHWAY HER-2/NEU (CLONE CD11) PRIMARY ANTIBODY
    PMA Number
    P990081
    Supplement Number
    S002
    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
    October 21, 2005
    Date Received
    September 6, 2005
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL OF LABELING CHANGES FOR THE PATHWAY HER-2/NEU (CLONE CD11) IN THE "INTENDED USE" SECTION, ADDITION OF AN "OPTIONAL EQUIPMENT NOT PROVIDED" SECTION AND CHANGES TO THE "PRINCIPLES AND PROCEDURES" SECTION TO REFLECT THE ADDITION OF TRIPATH IMAGING VIAS INSTRUMENT TO BE USED IN CONJUNCTION WITH THE VENTANA PATHWAY HER 2 ASSAY AS AN OPTIONAL ACCESSORY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE SAME TRADE NAME PATYHWAY HER-2/NEU (CLONE CD11) AND IS INDICATED: VENTANA MEDICAL SYSTEMS, INC.'S (VENTANA) PATHWAY HER 2 (CLONE CD11) IS A MOUSE MONOCLONAL ANTIBODY INTENDED FOR LABORATORY USE FOR THE SEMI-QUANTITATIVE DETECTION OF C-ERBB2- ANTIGEN IN SECTIONS OF FORMALIN FIXED, PARAFFIN EMBEDDED NORMAL AND NEOPLASTIC TISSUE ON A VENTANA AUTOMATED IMMUNOHISTOCHEM-ISTRY SLIDE STAINING DEVICE. IT IS INDICATED AS AN AID IN THE ASSESSMENT OF BREAST CANCER PATIENTS FOR WHOM HERCEPTIN TREATMENT IS CONSIDERED. NOTE: ALL OF THE PATIENTS IN THE HERCEPTIN CLINICAL TRIALS WERE SELECTED USING A CLINICAL TRIAL ASSAY. NONE OF THE PATIENTS IN THOSE TRIALS WERE SELECTED USING PATHWAY HER 2. THE PATHWAY HER 2 WAS COMPARED TO THE DAKO HERCEPTEST ON AN INDEPENDENT SAMPLE AND FOUND TO PROVIDE ACCEPTABLY CONCORDANT RESULTS. THE ACTUAL CORRELATION OF PATHWAY HER 2 TO CLINICAL OUTCOME HAS NOT BEEN ESTABLISHED. THE VENTANA IMAGE ANALYSIS SYSTEM (VIAS) IS ADJUNCTIVE OPTIONAL COMPUTER-ASSISTED IMAGE ANALYSIS SYSTEM FUNCTIONALLY CONNECTED TO AN INTERACTIVE MICROSCOPE. IT IS INTENDED FOR USE AS AN AID TO THE PATHOLOGIST IN THE DETECTION CLASSIFICATION AND COUNTING OF CELLS OF INTEREST BASED ON MARKET INTENSITY, SIZE AND SHAPE USING APPROPRIATE CONTROLS TO ASSURE THE VALIDITY OF THE VIAS SCORES.

    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