BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P190032 · Supplement: S017 · Decision Aug 1, 2024
    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 Liquid CDx (F1LCDx)
    PMA Number
    P190032
    Supplement Number
    S017
    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 1, 2024
    Date Received
    December 22, 2023
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for updates to the Library Construction (LC) and Hybrid Capture (HC) processes within the F1LCDx assay

    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