This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the cobas hbv. This device is indicated for: cobas hbv is an in vitro nucleic acid amplification test for the quantitation of hepatitis b virus (hbv) dna in human edta plasma or serum of hbv-infected individuals. This test is intended for use as an aid in the management of patients with chronic hbv infection undergoing anti-viral therapy. The test can be used to measure hbv dna levels at baseline and during treatment to aid in assessing response to treatment. The results from cobas hbv must be interpreted within the context of all relevant clinical and laboratory findings. The cobas hbv is not intended for use as a screening test for the presence of hbv in blood or blood products or as a diagnostic test to confirm the presence of hbv infection.
| Device | COBAS HBV TEST |
| Classification Name | Hepatitis Viral B Dna Detection |
| Generic Name | Hepatitis Viral B Dna Detection |
| Applicant | Roche Molecular Systems, Inc. |
| Date Received | 2015-04-24 |
| Decision Date | 2015-10-14 |
| Notice Date | 2015-11-05 |
| PMA | P150014 |
| Supplement | S |
| Product Code | MKT |
| Docket Number | 15M-4069 |
| Advisory Committee | Microbiology |
| 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 |
|---|---|---|
| P150014 | Original Filing | |
| S042 | 2021-12-20 | 30-day Notice |
| S041 | 2021-05-18 | Special (immediate Track) |
| S040 | 2020-11-13 | 30-day Notice |
| S039 | 2020-09-17 | Special (immediate Track) |
| S038 | 2020-07-27 | 30-day Notice |
| S037 | ||
| S036 | 2020-04-17 | 30-day Notice |
| S035 | 2020-01-10 | 30-day Notice |
| S034 | 2019-11-29 | 30-day Notice |
| S033 | 2019-09-20 | 30-day Notice |
| S032 | 2019-08-30 | 30-day Notice |
| S031 | 2019-08-06 | 30-day Notice |
| S030 | ||
| S029 | 2019-05-09 | 30-day Notice |
| S028 | 2019-05-09 | 30-day Notice |
| S027 | 2019-04-24 | 30-day Notice |
| S026 | 2019-04-24 | 30-day Notice |
| S025 | 2019-04-10 | 30-day Notice |
| S024 | 2019-04-03 | 30-day Notice |
| S023 | 2018-12-14 | 30-day Notice |
| S022 | 2018-11-13 | 30-day Notice |
| S021 | 2018-11-09 | 30-day Notice |
| S020 | 2018-08-21 | 30-day Notice |
| S019 | 2018-07-27 | 30-day Notice |
| S018 | 2018-06-29 | 30-day Notice |
| S017 | 2018-06-08 | 30-day Notice |
| S016 | 2018-06-04 | 30-day Notice |
| S015 | 2018-04-16 | 30-day Notice |
| S014 | 2018-03-01 | 30-day Notice |
| S013 | 2018-01-23 | 30-day Notice |
| S012 | 2017-11-22 | 30-day Notice |
| S011 | 2017-10-30 | 30-day Notice |
| S010 | 2017-09-27 | 30-day Notice |
| S009 | 2017-09-26 | 30-day Notice |
| S008 | 2017-07-14 | 30-day Notice |
| S007 | 2017-05-09 | 30-day Notice |
| S006 | 2016-11-22 | Special (immediate Track) |
| S005 | 2016-08-08 | Normal 180 Day Track |
| S004 | 2016-08-08 | Real-time Process |
| S003 | 2016-07-08 | 30-day Notice |
| S002 | 2016-04-07 | 30-day Notice |
| S001 | 2016-02-26 | 30-day Notice |