BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Somatic Gene Mutation Detection System

    PMA: P200014 · Decision Jun 18, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11

    Basic Information

    Device Name
    Somatic Gene Mutation Detection System
    Trade Name
    cobas® EZH2 Mutation Test
    PMA Number
    P200014
    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
    June 18, 2020
    Date Received
    March 2, 2020
    Expedited Review
    N
    Docket Number
    20M-1600

    Advisory Committee Statement

    Approval for The cobas® EZH2 Mutation Test. The device is a real-time allele-specific PCR test for qualitative detection of single nucleotide mutations for Y646N, Y646F or Y646X (Y646H, Y646S, or Y646C), A682G, and A692V of the EZH2 gene in DNA extracted from formalin fixed paraffin embedded (FFPE) human follicular lymphoma tumor tissue specimens. The cobas® EZH2 Mutation Test is intended for the identification of follicular lymphoma patients with an EZH2 mutation for treatment with TAZVERIK (tazemetostat), in accordance with the approved therapeutic product labeling.

    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