Approval for a post approval study labeling update. The device, as modified, will be marketed under the trade name aptima hpv 16 18/45 genotype assay. The aptima hpv 16 18/45 genotype assay is an in vitro nucleic acid amplification test for the qualitative detection of e6/e7 viral messenger rna (mrna) of human papillomavirus (hpv) types 16, 18, and 45 in cervical specimens from women with aptima hpv assay positive results. The aptima hpv 16 18/45 genotype assay can differentiate hpv 16 from hpv 18 and/or hpv 45, but does not differentiate between hpv 18 and hpv 45. Cervical specimens in thinprep pap test vials containing preservcyt solution and collected with broom-type or cytobrush/spatula collection devices* may be tested with the aptima hpv 16 18/45 genotype assay. The assay is used with the tigris dts system or the panther system. For further information please refer to the approval order.
| 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 | 2014-12-24 |
| Decision Date | 2015-06-05 |
| PMA | P120007 |
| Supplement | S003 |
| Product Code | OYB |
| Advisory Committee | Microbiology |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Labeling Change - Pas |
| 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