The autopap(r) primary screening system is an automated cervical cytology screening device intended for use in initial screening of papanicolaou (pap) smear slides. The autopap(r) primary screening system identifies up to 25% of successfully processed slides as requiring no further review. The autopap(r) primary screening system also identifies as least 15% of all successfully processed slides for a second manual review. The device is to be used only on conventionally prepared pap smear slides and 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.
| Device | AUTOPAP(R) 300 QC AUTOMATIC PAP SCREENER/QC SYSTEM |
| Classification Name | Reader, Cervical Cytology Slide, Automated |
| Generic Name | Reader, Cervical Cytology Slide, Automated |
| Applicant | BD DIAGNOSTICS |
| Date Received | 1996-06-06 |
| Decision Date | 1998-05-05 |
| Notice Date | 1998-08-12 |
| PMA | P950009 |
| Supplement | S002 |
| Product Code | MNM |
| Docket Number | 98M-0521 |
| Advisory Committee | Pathology |
| Supplement Type | Panel Track |
| 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