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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.
 
DeviceBD PREPSTAIN SYSTEM
Classification Nameprocessor, cervical cytology slide, automated
Generic Nameprocessor, cervical cytology slide, automated
Applicant
BD Diagnostic Systems
4025 stirrup creek drive
suite 400
durham, NC 27703
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/material
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 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.
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