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    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Somatic Gene Mutation Detection System

    PMA: P120014 · Decision May 29, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11

    Basic Information

    Device Name
    Somatic Gene Mutation Detection System
    Trade Name
    BIOMERIEUX THXID BRAF ASSAY KIT
    PMA Number
    P120014
    Device Class
    FDA Class 3
    Product Code
    OWD
    Generic Name
    Somatic gene mutation detection system
    Medical Specialty
    Unknown
    Advisory Committee
    Pathology
    Decision
    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    May 29, 2013
    Date Received
    July 31, 2012
    Expedited Review
    Y
    Docket Number
    13M-0709

    Advisory Committee Statement

    APPROVAL FOR THE THXID BRAF KIT FOR USE ON THE ABI 7500 FAST DX REAL-TIME PCR INSTRUMENT. THIS DEVICE IS INDICATED FOR: THE THXID BRAF KIT IS AN IN VITRO DIAGNOSTIC DEVICE INTENDED FOR THE QUALITATIVE DETECTION OF THE BRAF V600E AND V600K MUTATIONS IN DNA SAMPLES EXTRACTED FROM FORMALIN-FIXED PARAFFINEMBEDDED (FFPE) HUMAN MELANOMA TISSUE. THE THXID BRAF KIT IS A REAL-TIME PCR TEST ON THE ABI 7500 FAST DX SYSTEM AND IS INTENDED TO BE USED AS AN AID IN SELECTING MELANOMA PATIENTS WHOSE TUMORS CARRY THE BRAF V600E MUTATION FOR TREATMENT WITH DABRAFENIB [TAFINLAR®] AND AS AN AID IN SELECTING MELANOMA PATIENTS WHOSE TUMORS CARRY THE BRAF V600E OR V600K MUTATION FOR TREATMENT WITH TRAMETINIB [MEKINIST].

    Classifications

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

    Product Code Device Name
    OWD Somatic Gene Mutation Detection System