Approval for a post approval study labeling update. The device, as modified, will be marketed under the trade name aptima hpv assay. The aptima hpv assay is an in vitro nucleic acid amplification test for the qualitative detection of e6/e7 viral messenger rna (mrna) from 14 high-risk types of human papillomavirus (hpv) in cervical specimens. The high-risk hpv types detected by the assay include: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68. The aptima hpv assay does not discriminate between the 14 high-risk types. 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 assay. The assay is used with the tigris dts system or the panther system. The use of the test is indicated:1) to screen women 21 years and older with atypical squamous cells of undetermined significance (asc-us) cervical cytology results to determine the need for referral to colposcopy. The results of this test are not intended to prevent women from proceeding to colposcopy; and2) in women 30 years and older, the aptima hpv assay can be used with cervical cytology to adjunctively screen to assess the presence or absence of high-risk hpv types. This information, together with the physician¿s assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. * broom-type device (e. G. , wallach pipette) or endocervical brush/spatula.
| Device | APTIMA HPV 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 | P100042 |
| Supplement | S004 |
| 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 |
|---|
| P100042 | | Original Filing |
| S033 |
2022-01-19 |
30-day Notice |
| S032 | | |
| S031 |
2020-07-09 |
30-day Notice |
| S030 |
2020-05-14 |
30-day Notice |
| S029 |
2020-02-03 |
30-day Notice |
| S028 |
2019-12-23 |
Real-time Process |
| S027 | | |
| S026 |
2019-08-21 |
30-day Notice |
| S025 |
2019-08-02 |
30-day Notice |
| S024 | | |
| S023 |
2019-03-27 |
30-day Notice |
| S022 |
2019-03-18 |
Real-time Process |
| S021 |
2019-02-21 |
30-day Notice |
| S020 |
2018-12-31 |
Real-time Process |
| S019 |
2018-08-31 |
30-day Notice |
| S018 |
2018-08-16 |
30-day Notice |
| S017 |
2018-03-15 |
30-day Notice |
| S016 |
2018-02-08 |
30-day Notice |
| S015 |
2017-12-20 |
30-day Notice |
| S014 |
2017-10-10 |
30-day Notice |
| S013 |
2017-09-01 |
Normal 180 Day Track |
| S012 |
2017-03-17 |
Real-time Process |
| S011 |
2016-08-15 |
30-day Notice |
| S010 |
2016-04-25 |
30-day Notice |
| S009 |
2015-10-16 |
30-day Notice |
| S008 |
2015-08-28 |
135 Review Track For 30-day Notice |
| S007 |
2015-08-12 |
Normal 180 Day Track |
| S006 | | |
| S005 |
2015-03-04 |
30-day Notice |
| S004 |
2014-12-24 |
Normal 180 Day Track No User Fee |
| S003 |
2014-06-09 |
30-day Notice |
| S002 |
2014-04-17 |
Real-time Process |
| S001 |
2012-10-04 |
Normal 180 Day Track |
NIH GUDID Devices