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 ampliprep/cobas taqman cmv test. This device is indicated for: the cobas ampliprep/cobas taqman cmv test is an in vitro nucleic acid amplification test for the quantitative measurement of cytomegalovirus (cmv) dna in human edta plasma using the cobas ampliprep instrument for automated specimenprocessing and the cobas taqman analyzer or the cobas taqman 48 analyzer for automated amplification and detection. The cobas ampliprep/ cobas taqman cmv test is intended for use as an aid in the management of solid-organ transplant patients who are 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 cmvtest 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 (CAP/CTM CMV TEST) |
| Classification Name | Cytomegalovirus (cmv) Dna Quantitative Assay |
| Generic Name | Cytomegalovirus (cmv) Dna Quantitative Assay |
| Applicant | Roche Molecular Systems, Inc. |
| Date Received | 2011-10-24 |
| Decision Date | 2012-07-05 |
| Notice Date | 2012-07-11 |
| PMA | P110037 |
| Supplement | S |
| Product Code | PAB |
| Docket Number | 12M-0713 |
| 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 |
|---|---|---|
| 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 |