Approval for name changes from autpap primary screening system and autopap system to focalpoint system. The device, as modified, will be marketed under the trade name focalpoint system. The focalpoint system (autopap primary screening system) is indicated for: the focalpoint system is an automated cervicel cytology screening device intended for use in initial screening of cervical cytology clides. The focalpoint system identifies up to 25% of successfully processed slides as requiring no further review. The focalpoint system also identifies at least 15% of all successfully processed slides for a second manual review. The device is intended to be used on both conventionally-prepared and prepstain system cervical cytology slides. For both preparation methods, the device is intended to detect slides with evidence of squamous carcinoma and adenocarconoma 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.
| Device | FOCALPOINT SYSTEMCREENING SYSTEM |
| Classification Name | Reader, Cervical Cytology Slide, Automated |
| Generic Name | Reader, Cervical Cytology Slide, Automated |
| Applicant | BD DIAGNOSTICS |
| Date Received | 2001-10-26 |
| Decision Date | 2001-11-02 |
| PMA | P950009 |
| Supplement | S005 |
| Product Code | MNM |
| Advisory Committee | Pathology |
| Supplement Type | Real-time Process |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BD DIAGNOSTICS 4025 Stirrup Creek Drive suite 400 durham, NC 27703 |
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