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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.
Classification Nameprocessor, cervical cytology slide, automated
Generic Namecervical cytology slide preparation device
PMA NumberP970018
Supplement NumberS017
Date Received06/11/2009
Decision Date11/16/2009
Product Code
MKQ[ Registered Establishments with MKQ ]
Advisory Committee Pathology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order 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 surepath preservative fluid collection vial, prior to processing with the prepstain system, for testing with 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 the trade name prepstain system (formerly the autocyte prep system) and is indicated for a liquid-based thin layer cell preparation process. The prepstain system produces surepath slides that 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 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.