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    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Rt-Pcr Multigene Expression Test, Sentinel Lymph Node, Cancer Metastasis Detection

    PMA: P060017 · Decision Jul 16, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Rt-Pcr Multigene Expression Test, Sentinel Lymph Node, Cancer Metastasis Detection
    Trade Name
    GENESEARCH BREAST LYMPH NODE(BLN) ASSAY
    PMA Number
    P060017
    Device Class
    FDA Class 3
    Product Code
    OCB
    Generic Name
    RT-PCR multigene expression test, sentinel lymph node, cancer metastasis detection
    Medical Specialty
    Unknown
    Advisory Committee
    Pathology
    Decision
    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    July 16, 2007
    Date Received
    May 1, 2006
    Expedited Review
    N
    Docket Number
    07M-0413

    Advisory Committee Statement

    APPROVAL FOR THE GENESEARCH BREAST LYMPH NODE (BLN) ASSAY. THIS DEVICE IS INDICATED AS A QUALITATIVE, IN VITRO DIAGNOSTIC TEST FOR THE RAPID DETECTION OF GREATER THAN 0.2 MM METASTASES IN NODAL TISSUE REMOVED FROM SENTINEL LYMPH NODE BIOPSIES OF BREAST CANCER PATIENTS. RESULTS FROM THE ASSAY CAN BE USED TO GUIDE THE INTRA OPERATIVE OR POST-OPERATIVE DECISION TO REMOVE ADDITIONAL LYMPH NODES. POST-OPERATIVE HISTOLOGICAL EVALUATION OF PERMANENT SECTIONS OF THE TISSUE SPECIMEN, IN ACCORDANCE WITH USUAL DIAGNOSTIC PRACTICE AND USING THE VERIDEX LYMPH NODE CUTTING SCHEME, IS REQUIRED.

    Classifications

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

    Product Code Device Name
    OCB Rt-Pcr Multigene Expression Test, Sentinel Lymph Node, Cancer Metastasis Detection