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 cobas taqman hbv test for use with the high pure system. This device is indicated for: the cobas taqman hbv test for use with the high pure system is an in vitro nucleic acid amplification test for the quantitation of hepatitis b virus (hbv) dna in human serum or plasma (edta), using the high pure viral nucleic acid kit for manual specimen preparation and the cobas taqman 48 analyzer for automated amplification and detection. The test is intended for use as an aid in the management of patients with chronic hbv infection undergoing anti-viral therapy. The assay can be used to measure hbv dna levels at baseline and during treatment to aid in assessing response to treatment. The results from the cobas taqman hbv test must be interpreted within the context of all relevant clinical and laboratory findings. Assay performance characteristics have been established for individuals treated with adefovir dipivoxil. Assay performance for determining the state of hbv infection has not been established. The cobas taqman hbv test is not intended for use as a screening test for blood or blood products for the presence of hbv or as a diagnostic test to confirm the presence of hbv infection.
| Device | COBAS TAQMAN HBV TEST |
| Classification Name | Hepatitis Viral B Dna Detection |
| Generic Name | Hepatitis Viral B Dna Detection |
| Applicant | Roche Molecular Systems, Inc. |
| Date Received | 2005-08-02 |
| Decision Date | 2008-09-04 |
| Notice Date | 2008-09-11 |
| PMA | P050028 |
| Supplement | S |
| Product Code | MKT |
| Docket Number | 08M-0501 |
| 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 |
|---|---|---|
| P050028 | Original Filing | |
| S086 | 2022-10-21 | 30-day Notice |
| S085 | 2021-06-14 | 30-day Notice |
| S084 | 2021-02-23 | 30-day Notice |
| S083 | 2020-07-27 | 30-day Notice |
| S082 | 2020-04-17 | 30-day Notice |
| S081 | 2020-01-23 | 30-day Notice |
| S080 | 2019-10-08 | 30-day Notice |
| S079 | 2019-09-20 | 30-day Notice |
| S078 | 2019-08-16 | 30-day Notice |
| S077 | 2019-07-15 | Special (immediate Track) |
| S076 | 2019-04-24 | 30-day Notice |
| S075 | 2019-04-08 | 30-day Notice |
| S074 | 2019-03-20 | 30-day Notice |
| S073 | 2018-12-14 | 30-day Notice |
| S072 | 2018-11-13 | 30-day Notice |
| S071 | 2018-11-09 | 30-day Notice |
| S070 | 2018-08-21 | 30-day Notice |
| S069 | 2018-07-27 | 30-day Notice |
| S068 | 2018-06-29 | 30-day Notice |
| S067 | 2018-06-08 | 30-day Notice |
| S066 | 2018-06-04 | 30-day Notice |
| S065 | 2018-05-21 | 30-day Notice |
| S064 | 2018-04-16 | 30-day Notice |
| S063 | 2018-04-16 | 30-day Notice |
| S062 | 2018-04-16 | 30-day Notice |
| S061 | 2018-03-01 | 30-day Notice |
| S060 | 2017-11-14 | 30-day Notice |
| S059 | 2017-10-30 | 30-day Notice |
| S058 | 2017-09-26 | 30-day Notice |
| S057 | 2017-07-14 | 30-day Notice |
| S056 | 2017-07-14 | 30-day Notice |
| S055 | 2017-04-21 | Special (immediate Track) |
| S054 | 2016-09-22 | 30-day Notice |
| S053 | 2016-07-19 | 30-day Notice |
| S052 | 2016-07-08 | 30-day Notice |
| S051 | 2016-04-18 | 30-day Notice |
| S050 | 2016-04-07 | 30-day Notice |
| S049 | ||
| S048 | 2015-11-17 | Real-time Process |
| S047 | 2015-06-24 | 30-day Notice |
| S046 | 2015-04-09 | 30-day Notice |
| S045 | 2015-03-13 | 30-day Notice |
| S044 | 2015-02-25 | Real-time Process |
| S043 | 2014-12-19 | 30-day Notice |
| S042 | 2014-03-31 | 30-day Notice |
| S041 | 2014-03-18 | 30-day Notice |
| S040 | 2014-02-18 | 30-day Notice |
| S039 | 2013-12-26 | 30-day Notice |
| S038 | 2013-12-13 | 30-day Notice |
| S037 | 2013-09-09 | 30-day Notice |
| S036 | 2013-09-09 | 30-day Notice |
| S035 | 2013-08-14 | 30-day Notice |
| S034 | 2013-08-09 | 30-day Notice |
| S033 | 2013-05-28 | 30-day Notice |
| S032 | 2013-05-09 | 30-day Notice |
| S031 | 2013-04-08 | 30-day Notice |
| S030 | 2013-02-19 | Real-time Process |
| S029 | 2012-11-16 | Real-time Process |
| S028 | 2012-11-06 | Real-time Process |
| S027 | 2012-09-13 | 30-day Notice |
| S026 | 2012-08-15 | 30-day Notice |
| S025 | 2012-05-30 | Real-time Process |
| S024 | 2012-03-29 | Normal 180 Day Track No User Fee |
| S023 | 2011-12-12 | 135 Review Track For 30-day Notice |
| S022 | 2011-09-12 | 30-day Notice |
| S021 | 2011-09-01 | Special (immediate Track) |
| S020 | 2011-07-01 | Normal 180 Day Track |
| S019 | 2011-05-31 | Normal 180 Day Track No User Fee |
| S018 | ||
| S017 | 2011-03-08 | 135 Review Track For 30-day Notice |
| S016 | 2011-03-01 | 30-day Notice |
| S015 | 2011-03-01 | 135 Review Track For 30-day Notice |
| S014 | ||
| S013 | 2011-02-08 | 30-day Notice |
| S012 | 2010-11-08 | 30-day Notice |
| S011 | 2010-09-22 | 135 Review Track For 30-day Notice |
| S010 | ||
| S009 | ||
| S008 | 2010-08-05 | 30-day Notice |
| S007 | 2010-01-08 | 30-day Notice |
| S006 | 2009-12-24 | 30-day Notice |
| S005 | 2009-07-02 | 30-day Notice |
| S004 | 2009-07-01 | Normal 180 Day Track |
| S003 | 2008-12-05 | 30-day Notice |
| S002 | 2008-10-31 | 30-day Notice |
| S001 | 2008-10-06 | Real-time Process |