Approval forthe bd focalpoint gs imaging system. This device is indicated to assist in cervical cancerscreening of bd surepath pap test slides to detect evidence of squamous carcinoma,adenocarcinoma, and their usual precursor conditions. These slides will be ranked according tothe likelihood of abnormality, and provide relocation and visual review of up to 10 fields of view(fovs) most likely to contain abnormal cells. Additionally, the system identifies at least 15% ofall successfully processed slides with the bd focal point slide profiler* directed qctechnology for a directed qc re-screen. Intended users are trained cytology laboratorypersonnel operating under the direct supervision of a qualified cytology supervisor or laboratorymanager/director.
| Device | BD FOCALPOINT GS IMAGING SYSTEM |
| Classification Name | Reader, Cervical Cytology Slide, Automated |
| Generic Name | Reader, Cervical Cytology Slide, Automated |
| Applicant | BD DIAGNOSTICS |
| Date Received | 2007-10-02 |
| Decision Date | 2008-12-03 |
| Notice Date | 2009-01-27 |
| PMA | P950009 |
| Supplement | S008 |
| Product Code | MNM |
| Docket Number | 09M-0016 |
| Advisory Committee | Pathology |
| Supplement Type | Panel Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BD DIAGNOSTICS 4025 Stirrup Creek Drive suite 400 durham, NC 27703 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P950009 | | Original 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