BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Somatic Gene Mutation Detection System

    PMA: P210002 · Decision Jun 29, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11

    Basic Information

    Device Name
    Somatic Gene Mutation Detection System
    Trade Name
    therascreen PDGFRA RGQ PCR Kit
    PMA Number
    P210002
    Device Class
    FDA Class 3
    Product Code
    OWD
    Generic Name
    Somatic gene mutation detection system
    Medical Specialty
    Unknown
    Advisory Committee
    Medical Genetics
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    June 29, 2023
    Date Received
    January 29, 2021
    Expedited Review
    N
    Docket Number
    23M-3451

    Advisory Committee Statement

    Approval for the therascreen PDGFRA RGQ PCR Kit. The QIAGEN therascreen® PDGFRA RGQ PCR Kit is a real-time qualitative in vitro diagnostic assay for the detection of the D842V somatic mutation in the PDGFRA gene using genomic DNA extracted from Gastrointestinal Stromal Tumor (GIST) patients formalin-fixed paraffin-embedded (FFPE) tumor tissue. The therascreen PDGFRA RGQ PCR Kit is intended for use as a companion diagnostic test, to aid clinicians in identification of patients with GIST who may be eligible for treatment with AYVAKIT (avapritinib) based on a PDGFRA mutation detected result. FFPE tumor specimens are processed using the QIAamp® DSP DNA FFPE Tissue Kit for manual sample preparation and the Rotor-Gene® Q (RGQ) MDx instrument for automated amplification and detection. The therascreen PDGFRA RGQ PCR Kit is to be used by trained personnel in a professional laboratory environment.

    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