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 cobas® hpv test. The cobas® hpv test indications for use: the cobas® hpv test is a qualitative in vitro test for the detection of human papillomavirus in cervical specimens collected by a clinician using an endocervical brush/spatula and placed in the thinprep® pap testtm preservcyt® solution. The test utilizes amplification of target dna by the polymerase chain reaction (pcr) and nucleic acid hybridization for the detection of 14 high-risk (hr) hpv types in a single analysis. The test specifically identifies types hpv16 and hpv18 while concurrently detecting the rest of the high risk types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68). The cobas® hhpv test is indicated:1) to screen patients 21 years and older with asc-us (atypical squamous cells of undetermined significance) cervical cytology test results to determine the need for referral to colposcopy; 2) to be used in patients please see approval order for further information.
| Device | COBAS HPV TEST |
| Classification Name | Kit, Dna Detection, Human Papillomavirus |
| Generic Name | Kit, Dna Detection, Human Papillomavirus |
| Applicant | Roche Molecular Systems, Inc. |
| Date Received | 2013-07-01 |
| Decision Date | 2014-04-24 |
| Notice Date | 2014-04-24 |
| PMA | P100020 |
| Supplement | S008 |
| Product Code | MAQ |
| Docket Number | 14M-0552 |
| Advisory Committee | Microbiology |
| Supplement Type | Panel Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Roche Molecular Systems, Inc. 4300 Hacienda Drive pleasanton, CA 94588-2722 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P100020 | Original Filing | |
| S054 | 2022-10-21 | 30-day Notice |
| S053 | 2020-07-27 | 30-day Notice |
| S052 | 2020-06-01 | 30-day Notice |
| S051 | 2020-04-17 | 30-day Notice |
| S050 | 2019-09-20 | 30-day Notice |
| S049 | ||
| S048 | 2019-08-08 | 30-day Notice |
| S047 | 2019-04-24 | 30-day Notice |
| S046 | 2019-04-10 | 30-day Notice |
| S045 | 2019-04-08 | 30-day Notice |
| S044 | 2019-04-03 | 30-day Notice |
| S043 | 2019-02-04 | 30-day Notice |
| S042 | 2018-12-14 | 30-day Notice |
| S041 | 2018-11-13 | 30-day Notice |
| S040 | 2018-11-09 | 30-day Notice |
| S039 | 2018-10-25 | 30-day Notice |
| S038 | 2018-08-21 | 30-day Notice |
| S037 | 2018-07-27 | 30-day Notice |
| S036 | 2018-06-29 | 30-day Notice |
| S035 | 2018-06-08 | 30-day Notice |
| S034 | 2018-06-04 | 30-day Notice |
| S033 | 2018-05-23 | 30-day Notice |
| S032 | 2018-05-09 | Real-time Process |
| S031 | 2018-05-04 | 30-day Notice |
| S030 | 2018-04-16 | 30-day Notice |
| S029 | 2018-03-01 | 30-day Notice |
| S028 | 2017-12-07 | 30-day Notice |
| S027 | 2017-10-30 | 30-day Notice |
| S026 | 2017-09-26 | 30-day Notice |
| S025 | 2017-07-28 | Normal 180 Day Track |
| S024 | 2017-07-17 | 30-day Notice |
| S023 | 2017-07-14 | 30-day Notice |
| S022 | 2017-07-14 | 30-day Notice |
| S021 | 2016-09-22 | 30-day Notice |
| S020 | 2016-07-08 | 30-day Notice |
| S019 | 2016-04-18 | 30-day Notice |
| S018 | 2016-04-07 | 30-day Notice |
| S017 | 2015-12-23 | Panel Track |
| S016 | ||
| S015 | 2015-06-24 | 30-day Notice |
| S014 | 2015-03-13 | 30-day Notice |
| S013 | 2015-02-25 | Real-time Process |
| S012 | 2013-11-05 | Real-time Process |
| S011 | 2013-08-14 | 30-day Notice |
| S010 | 2013-08-09 | 30-day Notice |
| S009 | 2013-07-26 | 30-day Notice |
| S008 | 2013-07-01 | Panel Track |
| S007 | 2012-10-09 | 30-day Notice |
| S006 | 2012-08-15 | 30-day Notice |
| S005 | 2012-07-02 | Real-time Process |
| S004 | 2012-04-02 | Normal 180 Day Track |
| S003 | 2012-03-29 | Normal 180 Day Track No User Fee |
| S002 | 2011-12-12 | 135 Review Track For 30-day Notice |
| S001 | 2011-05-31 | Normal 180 Day Track No User Fee |