BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

    PMA: P160045 · Supplement: S028 · Decision Aug 25, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12

    Basic Information

    Device Name
    Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
    Trade Name
    Oncomine™ Dx Target Test
    PMA Number
    P160045
    Supplement Number
    S028
    Device Class
    FDA Class 3
    Product Code
    PQP
    Generic Name
    Next generation sequencing oncology panel, somatic or germline variant detection system
    Medical Specialty
    Unknown
    Advisory Committee
    Pathology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    August 25, 2021
    Date Received
    March 2, 2021
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N
    Docket Number
    21M-0962

    Advisory Committee Statement

    Approval to expand the intended use of the Oncomine Dx Target Test to include a companion diagnostic indication for the detection of single nucleotide variants in IDH1 in cholangiocarcinoma patients who may benefit from treatment with TIBSOVO (ivosidenib).

    Classifications

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

    Product Code Device Name
    PQP Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System