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 of the cobas cmv test - this device is indicated for:cobas® cmv is an in vitro nucleic acid amplification test for the quantitation of cytomegalovirus (cmv) dna in human edta plasma. Cobas® cmv is intended for use as an aid in the management of cmv in solid organ transplant patients and in hematopoietic stem cell transplant patients. In patients receiving anti-cmv therapy, serial dna measurements can be used to assess viral response to treatment. The results from cobas® cmv must be interpreted within the context of all relevant clinical and laboratory findings. Cobas® cmv is not intended for use as a screening test for blood or blood products.
| Device | COBAS CMV |
| Classification Name | Cytomegalovirus (cmv) Dna Quantitative Assay |
| Generic Name | Cytomegalovirus (cmv) Dna Quantitative Assay |
| Applicant | ROCHE MOLECULAR SYSTEMS, INC. |
| Date Received | 2016-09-21 |
| Decision Date | 2017-06-01 |
| Notice Date | 2017-06-07 |
| PMA | P160041 |
| Supplement | S |
| Product Code | PAB |
| Docket Number | 17M-3430 |
| 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 |
|---|---|---|
| P160041 | Original Filing | |
| S035 | 2022-05-31 | Normal 180 Day Track |
| S034 | 2021-12-20 | 30-day Notice |
| S033 | 2021-05-18 | Special (immediate Track) |
| S032 | 2020-11-13 | 30-day Notice |
| S031 | 2020-09-17 | Special (immediate Track) |
| S030 | 2020-07-27 | 30-day Notice |
| S029 | 2020-04-17 | 30-day Notice |
| S028 | 2020-01-10 | 30-day Notice |
| S027 | 2019-11-29 | 30-day Notice |
| S026 | 2019-09-20 | 30-day Notice |
| S025 | 2019-08-30 | 30-day Notice |
| S024 | 2019-08-06 | 30-day Notice |
| S023 | ||
| S022 | 2019-05-09 | 30-day Notice |
| S021 | 2019-05-09 | 30-day Notice |
| S020 | 2019-04-24 | 30-day Notice |
| S019 | 2019-04-24 | 30-day Notice |
| S018 | 2019-04-10 | 30-day Notice |
| S017 | 2019-04-03 | 30-day Notice |
| S016 | 2018-12-14 | 30-day Notice |
| S015 | 2018-11-13 | 30-day Notice |
| S014 | 2018-11-09 | 30-day Notice |
| S013 | 2018-08-21 | 30-day Notice |
| S012 | 2018-07-27 | 30-day Notice |
| S011 | 2018-06-29 | 30-day Notice |
| S010 | 2018-06-08 | 30-day Notice |
| S009 | 2018-06-04 | 30-day Notice |
| S008 | 2018-04-16 | 30-day Notice |
| S007 | 2018-03-01 | 30-day Notice |
| S006 | 2018-02-22 | 30-day Notice |
| S005 | 2018-01-23 | 30-day Notice |
| S004 | 2017-11-22 | 30-day Notice |
| S003 | 2017-10-30 | 30-day Notice |
| S002 | 2017-09-26 | 30-day Notice |
| S001 | 2017-07-14 | 30-day Notice |