BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor

    PMA: P030044 · Supplement: S001 · Decision Feb 1, 2006
    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 KIT
    PMA Number
    P030044
    Supplement Number
    S001
    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
    Decision Code
    APPR
    Decision Date
    February 1, 2006
    Date Received
    November 17, 2005
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR ADDITIONAL LABELING CHANGES INCLUDE A CLARIFICATION IN THE DEFINITION OF POSITIVE STAINING FOR INDIVIDUAL TUMOR CELLS, INCLUSION OF LIMITATION ABOUT CETUXIMAB RESPONSE RATE FOR NEGATIVE/ POSITIVE PATIENTS AND PERFORMANCE INDICES FOR PATIENTS WHO HAD <1% POSITIVE TUMOR CELLS FOR EGFR.

    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