Approval for the aptima hpv assay. Aptima hpv assay indications for use:the aptima hpv assay is an in vitro nucleic acid amplification test for the qualitative detectionofe6/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 the14 high-risk types. Cervical specimens in thinprep pap test vials containing preservcyt solutionand collected with broom-type or cytobrush/ spatula collection devices* may be tested with theaptima hpv assay. The assay is used with the tigris dts system. The use of the test is indicated:i. To screen patients 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 tocolposcopy. 2. In women 30 years and older, the aptima hpv assay can be used with cervical cytologyto 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.
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