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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DevicePREPSTAIN INSTRUMENT
Generic NameProcessor, cervical cytology slide, automated
ApplicantBD Diagnostic Systems
4025 STIRRUP CREEK DRIVE
SUITE 400
DURHAM, NC 27703
PMA NumberP970018
Supplement NumberS019
Date Received10/22/2009
Decision Date03/11/2010
Product Code MKQ 
Advisory Committee Pathology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL TO CHANGE THE DESIGN OF THE DITI (DISPOSABLE TIP) CONE OF THE PREPSTAIN INSTRUMENT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME BD PREPSTAIN¿ SYSTEM (FORMERLY AUTOCYTE®PREP SYSTEM) AND IS INDICATED FOR LIQUID-BASED THIN LAYER CELL PREPARATION PROCESS. THE PREPSTAIN SYSTEM PRODUCES SUREPATH SLIDES (FORMERLYAUTOCYTE®PREP SLIDES) THAT ARE INTENDED AS REPLACEMENT FOR CONVENTIONAL GYNECOLOGIC PAPSMEARS. SUREPATH SLIDES ARE INTENDED FOR USE IN THE SCREENING AND DETECTION OF CERVICAL CANCER,PRE-CANCEROUS LESIONS, ATYPICAL CELLS AND ALL OTHER CYTOLOGIC CATEGORIES AS DEFINED BY THE BETHESDA SYSTEM FOR REPORTING CERVICAL/VAGINAL CYTOLOGIC DIAGNOSES. SUREPATH PRESERVATIVE FLUID IS AN APPROPRIATE COLLECTION AND TRANSPORTATION MEDIUM FOR GYNECOLOGIC SPECIMENS TESTED WITH BDPROBETEC CHLAMYDIA TRACHOMATIS (CT) QX (CTQ) AND NEISSERIA GONORRHOEAE (GC) QX (GCQ)AMPLIFIED DNA ASSAYS.
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