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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NamePREPSTAIN INSTRUMENT
Classification Nameprocessor, cervical cytology slide, automated
Generic Namecervical cytology slide preparation device
ApplicantTRIPATH IMAGING, INC.
PMA NumberP970018
Supplement NumberS019
Date Received10/22/2009
Decision Date03/11/2010
Product Code
MKQ[ Registered Establishments with MKQ ]
Advisory Committee Hematology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
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 (formerly autocyte®prep slides) that are intended as replacement for conventional gynecologic pap smears. 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 bd probetec chlamydia trachomatis (ct) qx (ctq) and neisseria gonorrhoeae (gc) qx (gcq) amplified dna assays.
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