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    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    System, Test, Her-2/Neu, Nucleic Acid Or Serum

    PMA: P940004 · Decision Dec 30, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5

    Basic Information

    Device Name
    System, Test, Her-2/Neu, Nucleic Acid Or Serum
    Trade Name
    ONCOR(R) AMPLITECT(TM) HER/NEU(ERBB2)GENE AMPLIFI
    PMA Number
    P940004
    Device Class
    FDA Class 3
    Product Code
    MVD
    Generic Name
    SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM
    Medical Specialty
    Unknown
    Advisory Committee
    Pathology
    Decision
    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    December 30, 1997
    Date Received
    February 14, 1994
    Expedited Review
    N
    Docket Number
    98M-0712

    Advisory Committee Statement

    Approval for the Oncor(R) Inform(TM) HER-2/neu Gene Detection System. The Oncor(R) INFORM(TM) HER-2/neu Gene Detection System is a fluorescence in situ hybridization (FISH) DNA probe assay that determines the qualitative presence of HER-2/neu gene amplification on formalin-fixed, paraffin-embedded human breast tissue as an aid to stratify breast cancer patients according to risk for recurrence or disease-related death. It is indicated for use as an adjunct to existing clinical and pathologic information currently used as prognostic indicators in the risk stratification of breast cancer in patients who have had a priary, invasive, localized breast carcinoma and who are lymph node-negative.

    Classifications

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

    Product Code Device Name
    MVD System, Test, Her-2/Neu, Nucleic Acid Or Serum