BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Processor, Cervical Cytology Slide, Automated

    PMA: P970018 · Supplement: S017 · Decision Nov 16, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7

    Basic Information

    Device Name
    Processor, Cervical Cytology Slide, Automated
    Trade Name
    BD PREPSTAIN SYSTEM
    PMA Number
    P970018
    Supplement Number
    S017
    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 16, 2009
    Date Received
    June 11, 2009
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A MODIFICATION TO THE INTENDED USE OF THE PREPSTAIN SYSTEM TO ALLOW FOR THE REMOVAL OF A 0.5 ML ALIQUOT OF THE PATIENT SPECIMEN COLLECTED IN THE SUREPATHPRESERVATIVE FLUID COLLECTION VIAL, PRIOR TO PROCESSING WITH THE PREPSTAIN SYSTEM, FOR TESTINGWITH THE BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX (CTQ) AND NEISSERIA GONORRHOEAE(GC) QX (GCQ) AMPLIFIED DNA ASSAYS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THETRADE NAME PREPSTAIN SYSTEM (FORMERLY THE AUTOCYTE PREP SYSTEM) AND IS INDICATED FOR ALIQUID-BASED THIN LAYER CELL PREPARATION PROCESS. THE PREPSTAIN SYSTEM PRODUCES SUREPATH SLIDESTHAT ARE INTENDED AS REPLACEMENT FOR CONVENTIONAL GYNECOLOGICAL PAP SMEARS. SUREPALH SLIDES (FORMERLY THE AUTOCYTE PREP SLIDES) ARE INTENDED FOR USE IN THE SCREENING AND DETECTION OFCERVICAL CANCER, PRE-CANCEROUS LESIONS, ATYPICAL CELLS AND ALL OTHER CYTOLOGIC CATEGORIES AS DEFINED BY THE BETHESDA SYSTEM FOR REPORTING CERVICAL/VAGINAL CYTOLOGIC DIAGNOSES. SUREPATHPRESERVATIVE FLUID IS AN APPROPRIATE COLLECTION AND TRANSPORTATION MEDIUM FOR GYNECOLOGICSPECIMENS TESTED WITH BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX (CTQ) AND NEISSERIAGONORRHOEAE (GC) QX (GCQ) AMPLIFIED DNA ASSAYS.

    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