BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

    PMA: P060005 · Supplement: S005 · Decision Sep 7, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15

    Basic Information

    Device Name
    Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
    Trade Name
    FPSA IMMULITE ASSAY
    PMA Number
    P060005
    Supplement Number
    S005
    Device Class
    FDA Class 3
    Product Code
    MTG
    Generic Name
    Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
    Medical Specialty
    Unknown
    Advisory Committee
    Immunology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    September 7, 2011
    Date Received
    August 8, 2011
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    THE CHANGE IS TO IMPLEMENT USE OF A FULLY AUTOMATED FILLING AND PACKAGING LINE FOR THE IMMULITE CHEMILUSMINESCENT SUBSTRATE. THE CURRENT METHOD OF FILLING AND PACKAGING THE SUBSTRATE IS BY USE OF A SEMI-AUTOMATED LINE. FULL AUTOMATION OF THE LINE ELIMINATES REPETITIVE ACTIONS THAT ARE PERFORMED MANUALLY.

    Classifications

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

    Product Code Device Name
    MTG Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions