Approval for the aptima hpv 16 18/45 genotype assay. Aptima hpv 16 18/45 genotype assay indications for use: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 positiveresults. 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 orcytobrush/spatula collection devices* may be tested with the aptima hpv 16 18/45 genotype assay. The assay is used with the tigris dts system. The use of the test is indicated: 1) in patients 21 years and older with atypical squamous cells of undetermined significance(asc-us) cervical cytology results, the aptima hpv 16 18/45 genotype assay can be used to test samples from women with aptima hpv assay positive results to assess the presence or absence of high-risk hpv genotypes 16, 18, and/or 45. This information, together with the physician's assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. 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 16 18/45 genotype assay can be used to test samples from women with aptima hpv assay positive results. The assay results wi11 be used in combination with cervical cytology to assess the presence or absence of high-risk hpv genotypes 16, 18, and/or 45. 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 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 | 2012-04-19 |
| Decision Date | 2012-10-12 |
| Notice Date | 2012-11-01 |
| PMA | P120007 |
| Supplement | S |
| Product Code | OYB |
| Docket Number | 12M-1066 |
| Advisory Committee | Microbiology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | GEN-PROBE INCORPORATED 10210 Genetic Center Drive san Diego, CA 92121 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
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