BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Somatic Gene Mutation Detection System

    PMA: P170041 · Supplement: S006 · Decision Dec 1, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11

    Basic Information

    Device Name
    Somatic Gene Mutation Detection System
    Trade Name
    Abbott RealTime IDH1, Abbott RealTime IDH1 Amplification Reagent Kit, Abbott RealTime IDH1 Control Kit, Abbott RealTime
    PMA Number
    P170041
    Supplement Number
    S006
    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
    December 1, 2022
    Date Received
    December 17, 2021
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval to expand the indications for use of the Abbott RealTime IDH1 Assay to include a companion diagnostic indication for the detection of isocitrate dehydrogenase-1 (IDH1) mutations in patients with acute myeloid leukemia (AML) who may benefit from treatment with REZLIDHIA (olutasidenib).

    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