BEUDAMED
    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor

    PMA: P030044 · Decision Feb 12, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor
    Trade Name
    DAKOCYTOMATION EGFR PHARMDX
    PMA Number
    P030044
    Device Class
    FDA Class 3
    Product Code
    NQF
    Generic Name
    Immunohistochemistry assay, antibody, epidermal growth factor receptor
    Regulation Number
    864.1860
    Medical Specialty
    Hematology
    Advisory Committee
    Pathology
    Decision
    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    February 12, 2004
    Date Received
    September 29, 2003
    Expedited Review
    N
    Docket Number
    04M-0433

    Advisory Committee Statement

    APPROVAL FOR THE DAKOCYTOMATION EGFR PHARMDX. THE DEVICE IS INDICATED FOR: THE EGFR PHARMDX ASSAY IS A QUALITATIVE IMMUNOHISTOCHEMICAL (IHC) KIT SYSTEM TO IDENTIFY EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXPRESSION IN NORMAL AND NEOPLASTIC TISSUES ROUTINELY-FIXED FOR HISTOLOGICAL EVALUATION. EGFR PHARMDX SPECIFICALLY DETECTS THE EGFR (HER1) PROTEIN IN EGFR-EXPRESSING CELLS. EGFR PHARMDX IS INDICATED AS AN AID IN IDENTIFYING COLORECTAL CANCER PATIENTS ELIGIBLE FOR TREATMENT WITH ERBITUX (CETUXIMAB).

    Classifications

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

    Product Code Device Name
    NQF Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor