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.
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.
| Device | BD PREPSTAIN SYSTEM |
| Generic Name | Processor, Cervical Cytology Slide, Automated |
| Applicant | BD Diagnostic Systems |
| Date Received | 2009-06-11 |
| Decision Date | 2009-11-16 |
| PMA | P970018 |
| Supplement | S017 |
| Product Code | MKQ |
| Advisory Committee | Pathology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BD Diagnostic Systems 4025 Stirrup Creek Drive suite 400 durham, NC 27703 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P970018 | Original Filing | |
| S039 | 2021-09-24 | Real-time Process |
| S038 | 2021-02-19 | Real-time Process |
| S037 | 2021-01-21 | 30-day Notice |
| S036 | 2017-10-10 | Normal 180 Day Track No User Fee |
| S035 | 2017-07-17 | Normal 180 Day Track No User Fee |
| S034 | 2016-05-31 | 30-day Notice |
| S033 | 2016-05-27 | Real-time Process |
| S032 | 2015-03-26 | Normal 180 Day Track |
| S031 | 2015-01-22 | Normal 180 Day Track No User Fee |
| S030 | 2014-11-03 | Normal 180 Day Track |
| S029 | 2013-11-15 | 30-day Notice |
| S028 | 2013-10-31 | Normal 180 Day Track |
| S027 | 2013-09-30 | Special (immediate Track) |
| S026 | ||
| S025 | 2012-05-18 | 135 Review Track For 30-day Notice |
| S024 | 2011-08-24 | Special (immediate Track) |
| S023 | 2011-06-27 | Special (immediate Track) |
| S022 | ||
| S021 | 2010-04-05 | Real-time Process |
| S020 | 2010-02-18 | 30-day Notice |
| S019 | 2009-10-22 | Normal 180 Day Track |
| S018 | 2009-09-08 | Normal 180 Day Track No User Fee |
| S017 | 2009-06-11 | Normal 180 Day Track |
| S016 | 2009-06-09 | 30-day Notice |
| S015 | 2009-05-27 | Real-time Process |
| S014 | 2008-07-21 | Real-time Process |
| S013 | ||
| S012 | 2007-04-19 | Special (immediate Track) |
| S011 | ||
| S010 | 2005-09-01 | Real-time Process |
| S009 | 2005-01-10 | Real-time Process |
| S008 | ||
| S007 | 2003-12-01 | Normal 180 Day Track |
| S006 | 2003-03-24 | Normal 180 Day Track |
| S005 | 2002-08-26 | Normal 180 Day Track |
| S004 | 2002-07-02 | Normal 180 Day Track |
| S003 | 2001-10-26 | Real-time Process |
| S002 | 2000-12-01 | Normal 180 Day Track |
| S001 | 2000-08-08 | Real-time Process |