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.
Implementation of aql sampling in place of online 100% visual inspection for vials filled on 3 high-speed filling lines.
| Device | COBAS TaqMan HBV Test, High Pure System Viral Nucleic Acid Kit |
| Classification Name | Hepatitis Viral B Dna Detection |
| Generic Name | Hepatitis Viral B Dna Detection |
| Applicant | Roche Molecular Systems, Inc. |
| Date Received | 2016-09-22 |
| Decision Date | 2016-10-18 |
| PMA | P050028 |
| Supplement | S054 |
| Product Code | MKT |
| Docket Number | Premarket Approval (PMA) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radia |
| Advisory Committee | Microbiology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Roche Molecular Systems, Inc. 4300 Hacienda Drive pleasanton, CA 94588-2722 |
| 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 |