BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Somatic Gene Mutation Detection System

    PMA: P120022 · Supplement: S016 · Decision Jan 12, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11

    Basic Information

    Device Name
    Somatic Gene Mutation Detection System
    Trade Name
    Therascreen EGFR RGQ PCR Kit
    PMA Number
    P120022
    Supplement Number
    S016
    Device Class
    FDA Class 3
    Product Code
    OWD
    Generic Name
    Somatic gene mutation detection system
    Medical Specialty
    Unknown
    Advisory Committee
    Pathology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    January 12, 2018
    Date Received
    July 28, 2017
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for extending the labeling claim of the therascreen® EGFR RGQ PCR Kit to include detection of EGFR mutations L861Q, G719X and S768I, to aid in identifying patients with NSCLC for whom safety and efficacy of GILOTRIF® (afatininb) has been established.

    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