AUTOPAP PRIMARY SCREENING SYSTEM

Reader, Cervical Cytology Slide, Automated

FDA Premarket Approval P950009 S004

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 for use of the device with autocyte prep cervical cytology slides. The device, as modified, will be marketed under the trade name autopap primary screening system and is indicated for: the autopap primary screening system is an automated cervical cytology screening device intended for use in initial screening of cervical cytology slides. The autopap primary screening system identifies up to 25% of successfully processed slides as requiring no further review. The autopap primary screening system also identifies at lease 15% of all successfully processed slides for a second manual review. The device is intended to be used on both conventionally-prepared and autocyte prep cervical cytology slides. For both preparation methods, the device is intended to detect slides with evidence of squamous carcinoma and adenocarcinoma and their usual precursor conditions; it is not intended to be used on slides designated by the laboratory as high risk. Intended users are trained cytology laboratory personnel operating under the direct supervision of a qualified cytology supervisor or laboratory manager/director.

DeviceAUTOPAP PRIMARY SCREENING SYSTEM
Classification NameReader, Cervical Cytology Slide, Automated
Generic NameReader, Cervical Cytology Slide, Automated
ApplicantBD DIAGNOSTICS
Date Received1999-10-01
Decision Date2001-10-05
PMAP950009
SupplementS004
Product CodeMNM
Advisory CommitteePathology
Supplement TypeNormal 180 Day Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address BD DIAGNOSTICS 4025 Stirrup Creek Drive suite 400 durham, NC 27703

Supplemental Filings

Supplement NumberDateSupplement Type
P950009Original Filing
S026 2022-06-15 30-day Notice
S025 2021-09-02 Real-time Process
S024 2021-03-04 30-day Notice
S023 2019-11-19 30-day Notice
S022 2019-06-05 Normal 180 Day Track
S021 2016-05-19 30-day Notice
S020 2016-03-07 Normal 180 Day Track No User Fee
S019 2015-04-24 Real-time Process
S018 2014-11-12 Normal 180 Day Track
S017 2013-12-02 Real-time Process
S016 2012-07-05 Real-time Process
S015 2012-03-28 Normal 180 Day Track
S014 2012-01-17 Real-time Process
S013 2011-09-15 Real-time Process
S012 2010-08-17 Special (immediate Track)
S011 2009-12-10 30-day Notice
S010 2009-06-25 Normal 180 Day Track No User Fee
S009 2009-03-26 Real-time Process
S008 2007-10-02 Panel Track
S007
S006
S005 2001-10-26 Real-time Process
S004 1999-10-01 Normal 180 Day Track
S003 1998-10-13 Normal 180 Day Track
S002 1996-06-06 Panel Track
S001 1995-11-06 Special (immediate Track)

NIH GUDID Devices

Device IDPMASupp
00382904901899 P950009 008
00382904910877 P950009 015
00382904910860 P950009 015
00382904910853 P950009 015
00382904910907 P950009 015
00382904914646 P950009 022

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.