BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer

    PMA: P190022 · Supplement: S001 · Decision Jan 8, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2

    Basic Information

    Device Name
    Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer
    Trade Name
    4Kscore Test
    PMA Number
    P190022
    Supplement Number
    S001
    Device Class
    FDA Class 3
    Product Code
    QRF
    Generic Name
    Multi-analyte test system with algorithmic analysis for detection of prostate cancer
    Medical Specialty
    Unknown
    Advisory Committee
    Immunology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    January 8, 2024
    Date Received
    August 24, 2023
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval to transfer the manufacturing site for the preparation of two (iPSA and hK2) of the four 4Kscore Test reagents from the original site, OPKO Diagnostics, LLC., Woburn, Massachusetts, to a new manufacturing site, BioReference Health, LLC., Elmwood Park, New Jersey (BioReference).

    Classifications

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

    Product Code Device Name
    QRF Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer