PREPSTAIN INSTRUMENT

FDA Premarket Approval P970018 S019

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.

Pre-market Approval Supplement Details

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.

DevicePREPSTAIN INSTRUMENT
Generic NameProcessor, Cervical Cytology Slide, Automated
ApplicantBD Diagnostic Systems
Date Received2009-10-22
Decision Date2010-03-11
PMAP970018
SupplementS019
Product CodeMKQ 
Advisory CommitteePathology
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address BD Diagnostic Systems 4025 Stirrup Creek Drive suite 400 durham, NC 27703

Supplemental Filings

Supplement NumberDateSupplement Type
P970018Original 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

NIH GUDID Devices

Device IDPMASupp
30382904905201 P970018 000
00382904901004 P970018 000
00382904913113 P970018 000
00382904912895 P970018 000
00382904913328 P970018 000
00382904913373 P970018 000
30382904913305 P970018 000
30382904913299 P970018 000
30382904913244 P970018 000
00382904912673 P970018 000
00382904912666 P970018 000
00382904914547 P970018 000
00382904913069 P970018 000
00382904904074 P970018 001
00382904905231 P970018 001
00382904912475 P970018 001
00382904905286 P970018 001
00382904905408 P970018 001
00382904905217 P970018 001
30382904905225 P970018 001
00382904909857 P970018 001
30382904905119 P970018 001
00382904905415 P970018 001
00382904905071 P970018 001
00382904910952 P970018 002
00382904904104 P970018 002
00382904901042 P970018 002
30382904905171 P970018 002
10382904905276 P970018 002
10382904913318 P970018 002
30382904913312 P970018 002
00382904914554 P970018 002
00382904913137 P970018 002
00382904910969 P970018 002
00382904910976 P970018 002
30382904912483 P970018 025
00382904911034 P970018 028
00382904912574 P970018 028
00382904912888 P970018 028
00382904914561 P970018 030
00382904913885 P970018 030
00382904913465 P970018 030
00382904913083 P970018 030
30382904914524 P970018 032
10382904912533 P970018 032
00382904914530 P970018 032
00382904914400 P970018 032
00382904913106 P970018 032
00382904914394 P970018 032
00382904433277 P970018 032
00382904914387 P970018 032
00382904913892 P970018 032

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