Approval for the addition of the panther system to the aptima® hpv assay. 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 collected in thinprep pap test vials containing presesrvcyt 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; and 2) 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 physicians 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 | 2012-10-04 |
| Decision Date | 2013-07-15 |
| PMA | P100042 |
| Supplement | S001 |
| 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 |
|---|
| 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