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 the addition of the panther system to the aptima® hpv 16 18/45 genotype assay. 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 | 2013-05-15 |
Decision Date | 2013-11-06 |
PMA | P120007 |
Supplement | S001 |
Product Code | OYB |
Advisory Committee | Microbiology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
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 |