Approval for the use of the aptima hpv 16 18/45 genotype assay on panther systems equipped with a panther fusion module. The changes required for addition of the panther fusion module that are subject to this approval include reconfiguration of the panther system hardware, and updates to the panther system and aptima hpv 16 18/45 genotype assay software.
| Device | Aptima HPV 16 18/45 Genotype Assay |
| Classification Name | Kit, Rna Detection, Human Papillomavirus |
| Generic Name | Kit, Rna Detection, Human Papillomavirus |
| Applicant | GEN-PROBE INCORPORATED |
| Date Received | 2017-09-01 |
| Decision Date | 2018-02-23 |
| PMA | P120007 |
| Supplement | S011 |
| Product Code | OYB |
| Advisory Committee | Microbiology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | GEN-PROBE INCORPORATED 10210 Genetic Center Drive san Diego, CA 92121 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P120007 | | Original Filing |
| S029 |
2021-12-14 |
Real-time Process |
| S028 |
2020-07-09 |
30-day Notice |
| S027 |
2020-05-14 |
30-day Notice |
| S026 |
2019-12-23 |
Real-time Process |
| S025 | | |
| S024 |
2019-08-21 |
30-day Notice |
| S023 |
2019-08-02 |
30-day Notice |
| S022 | | |
| S021 |
2019-03-27 |
30-day Notice |
| S020 |
2019-03-18 |
Real-time Process |
| S019 |
2019-03-01 |
Real-time Process |
| S018 |
2018-12-31 |
Real-time Process |
| S017 |
2018-08-31 |
30-day Notice |
| S016 |
2018-08-16 |
30-day Notice |
| S015 |
2018-03-15 |
30-day Notice |
| S014 |
2018-02-08 |
30-day Notice |
| S013 |
2017-12-20 |
30-day Notice |
| S012 |
2017-10-10 |
30-day Notice |
| S011 |
2017-09-01 |
Normal 180 Day Track |
| S010 |
2017-03-17 |
Real-time Process |
| S009 |
2016-08-15 |
30-day Notice |
| S008 |
2016-03-01 |
30-day Notice |
| S007 |
2015-10-16 |
30-day Notice |
| S006 |
2015-08-28 |
135 Review Track For 30-day Notice |
| S005 | | |
| S004 |
2015-03-04 |
30-day Notice |
| S003 |
2014-12-24 |
Normal 180 Day Track No User Fee |
| S002 |
2014-04-17 |
Real-time Process |
| S001 |
2013-05-15 |
Normal 180 Day Track |
NIH GUDID Devices