BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P040005 · Supplement: S005 · Decision Oct 20, 2010
    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
    HER2 FISH PHARMDX KIT
    PMA Number
    P040005
    Supplement Number
    S005
    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
    Decision Code
    APPR
    Decision Date
    October 20, 2010
    Date Received
    April 20, 2010
    Supplement Type
    Panel Track
    Expedited Review
    N
    Docket Number
    10M-0558

    Advisory Committee Statement

    APPROVAL FOR THE HER2 FISH PHARMDX KIT. THE DEVICE IS INDICATED FOR IN VITRO DIAGNOSTIC USE. THE HER2 FISH PHARMDX KIT IS A DIRECT FLUORESCENCE IN SITU HYBRIDIZATION (FISH) ASSAY DESIGNED TO QUANTITATIVELY DETERMINE HER2 GENE AMPLIFICATION IN FORMALIN-FIXED, PARAFFIN-EMBEDDED (FFPE) BREAST CANCER TISSUE SPECIMENS AND FFPE SPECIMENS FROM PATIENTS WITH METASTATIC GASTRIC OR GASTROESOPHAGEAL JUNCTION ADENOCARCINOMA. HER2 FISH PHARMDX KIT IS INDICATED AS AN AID IN THE ASSESSMENT OF PATIENTS FOR WHOM HERCEPTIN (TRASTUZUMAB) TREATMENT IS BEING CONSIDERED (SEE HERCEPTIN PACKAGE INSERT).

    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