BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Processor, Cervical Cytology Slide, Automated

    PMA: P970018 · Supplement: S002 · Decision May 25, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7

    Basic Information

    Device Name
    Processor, Cervical Cytology Slide, Automated
    Trade Name
    AUTOCYTE PREP SYSTEM
    PMA Number
    P970018
    Supplement Number
    S002
    Device Class
    FDA Class 3
    Product Code
    MKQ
    Generic Name
    Processor, cervical cytology slide, automated
    Medical Specialty
    Unknown
    Advisory Committee
    Pathology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 25, 2001
    Date Received
    December 1, 2000
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ADDITION OF THE PREPMATE ACCESSORY (PREPMATE METHOD), WHICH AUTOMATES THE INITIAL MANUAL STEPS OF THE AUTOCYTE PREP LABORATORY PROCESS. THE PREPMATE AUTOMATICALLY MIXES AND REMOVES THE SPECIMEN FROM THE GYN PRESERVATIVE VIALS, AND LAYERS THE SPECIMEN ONTO CYTORICH DENSITY REAGENT IN A TEST TUBE, AND FOR THE ADDITION OF THE MANUAL METHOD, IN WHICH, RATHER THAN USING THE AUTOCYTE PREP SYSTEM FOR CELL SUSPENSION AND SLIDE STAINING, THE CELL SUSPENSION IS MANUALLY LAYERED ONTO THE SLIDE AND STAINED BY A LABORATORY TECHNICIAN.

    Classifications

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

    Product Code Device Name
    MKQ Processor, Cervical Cytology Slide, Automated