BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Reader, Cervical Cytology Slide, Automated

    PMA: P950009 · Supplement: S004 · Decision Oct 5, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    Reader, Cervical Cytology Slide, Automated
    Trade Name
    AUTOPAP PRIMARY SCREENING SYSTEM
    PMA Number
    P950009
    Supplement Number
    S004
    Device Class
    FDA Class 3
    Product Code
    MNM
    Generic Name
    READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
    Medical Specialty
    Unknown
    Advisory Committee
    Pathology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    October 5, 2001
    Date Received
    October 1, 1999
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR USE OF THE DEVICE WITH AUTOCYTE PREP CERVICAL CYTOLOGY SLIDES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME AUTOPAP PRIMARY SCREENING SYSTEM AND IS INDICATED FOR: THE AUTOPAP PRIMARY SCREENING SYSTEM IS AN AUTOMATED CERVICAL CYTOLOGY SCREENING DEVICE INTENDED FOR USE IN INITIAL SCREENING OF CERVICAL CYTOLOGY SLIDES. THE AUTOPAP PRIMARY SCREENING SYSTEM IDENTIFIES UP TO 25% OF SUCCESSFULLY PROCESSED SLIDES AS REQUIRING NO FURTHER REVIEW. THE AUTOPAP PRIMARY SCREENING SYSTEM ALSO IDENTIFIES AT LEASE 15% OF ALL SUCCESSFULLY PROCESSED SLIDES FOR A SECOND MANUAL REVIEW. THE DEVICE IS INTENDED TO BE USED ON BOTH CONVENTIONALLY-PREPARED AND AUTOCYTE PREP CERVICAL CYTOLOGY SLIDES. FOR BOTH PREPARATION METHODS, THE DEVICE IS INTENDED TO DETECT SLIDES WITH EVIDENCE OF SQUAMOUS CARCINOMA AND ADENOCARCINOMA AND THEIR USUAL PRECURSOR CONDITIONS; IT IS NOT INTENDED TO BE USED ON SLIDES DESIGNATED BY THE LABORATORY AS HIGH RISK. INTENDED USERS ARE TRAINED CYTOLOGY LABORATORY PERSONNEL OPERATING UNDER THE DIRECT SUPERVISION OF A QUALIFIED CYTOLOGY SUPERVISOR OR LABORATORY MANAGER/DIRECTOR.

    Classifications

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

    Product Code Device Name
    MNM Reader, Cervical Cytology Slide, Automated