BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P170019 · Supplement: S048 · Decision Nov 16, 2023
    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
    FoundationOne CDx (F1CDx)
    PMA Number
    P170019
    Supplement Number
    S048
    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
    November 16, 2023
    Date Received
    July 3, 2023
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N
    Docket Number
    24M-0044

    Advisory Committee Statement

    Approval order to expand the intended use of FoundationOne®CDx (F1CDx) to include a companion diagnostic (CDx) indication for the detection of PIK3CA/AKT1/PTEN-alterations in patients with breast cancer who may benefit from treatment with TRUQAP™(capivasertib) in combination with FASLODEX®(fulvestrant).

    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