This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
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 |
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 |