BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Processor, Cervical Cytology Slide, Automated

    PMA: P970018 · Supplement: S003 · Decision Nov 2, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7

    Basic Information

    Device Name
    Processor, Cervical Cytology Slide, Automated
    Trade Name
    PREPSTAIN SYSTEM
    PMA Number
    P970018
    Supplement Number
    S003
    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
    November 2, 2001
    Date Received
    October 26, 2001
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR NAME CHANGES FROM AUTOCYTE PREP SYSTEM TO PREPSTAIN SYSTEM AND FROM CYTORICH TO SUREPATH. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES PREPSTAIN SYSTEM AND SUREPATH. THE PREPSTAIN SYSTEM AND SUREPATH IS INDICATED AS A LIQUID-BASED, THIN LAYER CELL PREPARATION PROCESS. THE PREPSTAIN SYSTEM PRODUCES SLIDES THAT ARE INTENDED AS REPLACEMENTS FOR CONVENTIONAL GYNECOLOGIC PAP SMEARS. THE PREPSTAIN SLIDES ARE INTENDED FOR USE IN THE SCREENING AND DETECTION OF CERVICAL CANCER, PRECANCEROUS LESIONS, ATYPICAL CELLS AND ALL OTHER CYTOLOGIC CATEGORIES AS DEFINED BY THE BETHESDA SYSTEM FOR REPORTING CERVICAL/VAGINAL CYTOLOGIC DIAGNOSES.

    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