BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

    PMA: P930027 · Supplement: S004 · Decision Jun 19, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    37
    Registration Numbers
    37

    Basic Information

    Device Name
    Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
    Trade Name
    IMMULITE(R)PSA, IMMULITE(R) THIRD GENERATION PSA, IMMULITE(R) 2000
    PMA Number
    P930027
    Supplement Number
    S004
    Device Class
    FDA Class 2
    Product Code
    LTJ
    Generic Name
    PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
    Regulation Number
    866.6010
    Medical Specialty
    Immunology
    Advisory Committee
    Immunology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    June 19, 2001
    Date Received
    January 2, 2001
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N
    Docket Number
    01M-0535

    Advisory Committee Statement

    IMMULITE PSA, IMMULITE. THIRD GENERATION PSA, IMMULITE 2000 PSA, AND IMMULITE 2000 THIRD GENERATION PSA. IMMULITE. PSA IS INDICATED FOR IN VITRO DIAGNOSTIC USE WITH THE IMMULITE ANALYZER FOR THE QUANTITATIVE MEASUREMENT OF PROSTATE-SPECIFIC ANTIGEN (PSA) IN HUMAN SERUM, AS AN AID IN THE DETECTION OF PROSTATE CANCER WHEN USED IN CONJUNCTION WITH DIGITAL RECTAL EXAMINATION (DRE) IN MEN AGED 50 YEARS OR OLDER. IMMULITE THIRD GENERATION PSA IS INDICATED FOR IN VITRO DIAGNOSTIC USE WITH THE IMMULITE ANALYZER FOR THE QUANTITATIVE MEASUREMENT OF PROSTATE-SPECIFIC ANTIGEN (PSA) IN HUMAN SERUM, AS AN AID IN THE DETECTION OF PROSTATE CANCER WHEN USED IN CONJUNCTION WITH DIGITAL RECTAL EXAMINATION (DRE) IN MEN AGED 50 YEARS OR OLDER. IMMULITE 2000 PSA IS INDICATED FOR IN VITRO DIAGNOSTIC USE WITH THE IMMULITE 2000 ANALYZER FOR THE QUANTITATIVE MEASUREMENT OF PROSTATE-SPECIFIC ANTIGEN (PSA) IN HUMAN SERUM, AS AN AID IN THE DETECTION OF PROSTATE CANCER WHEN USED IN CONJUNCTION WITH DIGITAL RECTAL EXAMINATION (DRE) IN MEN AGED 50 YEARS OR OLDER. IMMULITE 2000 THIRD GENERATION PSA IS INDICATED FOR IN VITRO DIAGNOSTIC USE WITH THE IMMULITE 2000 ANALYZER FOR THE QUANTITATIVE MEASUREMENT OF PROSTATE-SPECIFIC ANTIGEN (PSA) IN HUMAN SERUM, AS AN AID IN THE DETECTION OF PROSTATE CANCER WHEN USED IN CONJUNCTION WITH DIGITAL RECTAL EXAMINATION (DRE) IN MEN AGED 50 YEARS OF OLDER.

    Classifications

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

    Product Code Device Name
    LTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers