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 a change to the test definition file (tdf). The device, as modified, will be marketed under the trade name cobas ampliprep/cobas taqman cmv test and is indicated for: cobas ampliprep/cobas taqman cmv test the cobas ampliprep/ cobas taqman cmv test is an in vitro nucleic acid amplification test for the quantitative measurement of cytomegalovirus (cmv) dna inhuman edta plasma using the cobas ampliprcp instrument for automated specimen processing and the cobas taqman analyzer or the cobas taqman 48 analyzer for automated amplification and detection. The cobas ampliprcp/ cobas taqman cmv test is intended for usc as an aid in the management ofsolid-organ transplant patients who arc undergoing anti-cmv therapy. In this population serial dna measurements can be used to assess virological response to antiviral treatment. The results from the cobas ampliprep/cobas taqman cmv test must be interpreted within the context of all relevant clinical and laboratory findings. The cobas ampliprep/ cobas taqman cmv test is not intended for use as a screening test for the presence of cmv dna in blood or blood products.
| Device | COBAS AMPLIPREP/COBAS TAQMAN CMV TEST |
| Classification Name | Cytomegalovirus (cmv) Dna Quantitative Assay |
| Generic Name | Cytomegalovirus (cmv) Dna Quantitative Assay |
| Applicant | Roche Molecular Systems, Inc. |
| Date Received | 2012-08-07 |
| Decision Date | 2012-09-05 |
| PMA | P110037 |
| Supplement | S001 |
| Product Code | PAB |
| Advisory Committee | Microbiology |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Roche Molecular Systems, Inc. 4300 Hacienda Drive pleasanton, CA 94588-2722 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P110037 | Original Filing | |
| S057 | 2022-10-21 | 30-day Notice |
| S056 | 2021-06-14 | 30-day Notice |
| S055 | 2021-02-23 | 30-day Notice |
| S054 | 2020-07-27 | 30-day Notice |
| S053 | 2020-04-17 | 30-day Notice |
| S052 | 2020-01-23 | 30-day Notice |
| S051 | 2019-10-08 | 30-day Notice |
| S050 | 2019-09-20 | 30-day Notice |
| S049 | 2019-08-16 | 30-day Notice |
| S048 | 2019-07-15 | Special (immediate Track) |
| S047 | 2019-04-24 | 30-day Notice |
| S046 | 2019-04-10 | 30-day Notice |
| S045 | 2019-03-20 | 30-day Notice |
| S044 | 2018-12-14 | 30-day Notice |
| S043 | 2018-11-13 | 30-day Notice |
| S042 | 2018-11-09 | 30-day Notice |
| S041 | 2018-08-21 | 30-day Notice |
| S040 | 2018-07-27 | 30-day Notice |
| S039 | 2018-06-29 | 30-day Notice |
| S038 | 2018-06-08 | 30-day Notice |
| S037 | 2018-06-04 | 30-day Notice |
| S036 | 2018-04-16 | 30-day Notice |
| S035 | 2018-04-16 | 30-day Notice |
| S034 | 2018-03-01 | 30-day Notice |
| S033 | 2017-11-14 | 30-day Notice |
| S032 | 2017-09-26 | 30-day Notice |
| S031 | 2017-07-14 | 30-day Notice |
| S030 | 2017-07-14 | 30-day Notice |
| S029 | 2016-09-22 | 30-day Notice |
| S028 | 2016-07-19 | 30-day Notice |
| S027 | 2016-07-08 | 30-day Notice |
| S026 | 2016-04-18 | 30-day Notice |
| S025 | 2016-04-07 | 30-day Notice |
| S024 | 2015-11-17 | Real-time Process |
| S023 | 2015-10-22 | Normal 180 Day Track |
| S022 | 2015-06-24 | 30-day Notice |
| S021 | 2015-04-09 | 30-day Notice |
| S020 | 2015-03-13 | 30-day Notice |
| S019 | 2015-02-25 | Real-time Process |
| S018 | 2014-12-19 | 30-day Notice |
| S017 | 2014-12-19 | 30-day Notice |
| S016 | 2014-12-16 | Real-time Process |
| S015 | 2014-03-31 | 30-day Notice |
| S014 | 2014-03-18 | 30-day Notice |
| S013 | 2014-02-18 | 30-day Notice |
| S012 | 2013-10-30 | 30-day Notice |
| S011 | 2013-09-09 | 30-day Notice |
| S010 | 2013-09-09 | 30-day Notice |
| S009 | 2013-08-14 | 30-day Notice |
| S008 | 2013-08-09 | 30-day Notice |
| S007 | 2013-07-26 | 30-day Notice |
| S006 | 2013-05-09 | 30-day Notice |
| S005 | 2013-02-19 | Special (immediate Track) |
| S004 | 2012-11-16 | Real-time Process |
| S003 | 2012-11-02 | Real-time Process |
| S002 | 2012-08-15 | 30-day Notice |
| S001 | 2012-08-07 | Real-time Process |