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 cobasampliprep/cobas taqman hcv test. This device is an in vitro nucleic acid amplification lestfor the quantitation of hepatitis c viral (hcv) rna in human plasma or serum of hcv-infectedindividuals using the cobas ampliprep instrument for automated specimen processing and thecobas taqman analyzer or the cobas taqman 48 analyzer for automated amplification anddetection. Specimens containing hcv genotypes 1 - 6 have been validated for quantitation inthe assay. The cobas ampliprep/cobas taqman hcv test is intended for use as an aid in themanagement of hcv-infected individuals undergoing anti-viral therapy. The assay measureshcv rna levels at baseline and during treatment and can be utilized to predict sustained andnon-sustained virological response to hcv therapy. The results from the cobasampiprep/cobas taqman hcv test must be interpreted within the context of all relevant clinical and laboratory findings. Assay performance characteristics have been established for individuals treated with peginterferon alfa-2a plus ribavirin. No information is available on the assay's predictive value when other therapies are used. Assay performance for determining the slate of hcv infection has not been established. "
| Device | COBAS AMPLIPREP/COBAS TAQMAN HCV TEST |
| Classification Name | Assay, Hybridization And/or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,hepatitis C Virus |
| Generic Name | Assay, Hybridization And/or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,hepatitis C Virus |
| Applicant | Roche Molecular Systems, Inc. |
| Date Received | 2006-10-27 |
| Decision Date | 2008-10-30 |
| Notice Date | 2009-01-27 |
| PMA | P060030 |
| Supplement | S |
| Product Code | MZP |
| Docket Number | 09M-0033 |
| 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 |
|---|---|---|
| P060030 | Original Filing | |
| S086 | 2021-06-14 | 30-day Notice |
| S085 | 2021-02-23 | 30-day Notice |
| S084 | 2020-07-27 | 30-day Notice |
| S083 | 2020-04-17 | 30-day Notice |
| S082 | 2020-01-23 | 30-day Notice |
| S081 | 2019-10-08 | 30-day Notice |
| S080 | 2019-09-20 | 30-day Notice |
| S079 | 2019-08-16 | 30-day Notice |
| S078 | 2019-07-15 | Special (immediate Track) |
| S077 | 2019-05-23 | Real-time Process |
| S076 | 2019-04-24 | 30-day Notice |
| S075 | 2019-04-10 | 30-day Notice |
| S074 | 2019-04-08 | 30-day Notice |
| S073 | 2019-03-20 | 30-day Notice |
| S072 | 2018-12-14 | 30-day Notice |
| S071 | 2018-11-13 | 30-day Notice |
| S070 | 2018-11-09 | 30-day Notice |
| S069 | 2018-08-21 | 30-day Notice |
| S068 | 2018-07-27 | 30-day Notice |
| S067 | 2018-06-29 | 30-day Notice |
| S066 | 2018-06-08 | 30-day Notice |
| S065 | 2018-06-04 | 30-day Notice |
| S064 | 2018-04-16 | 30-day Notice |
| S063 | 2018-04-16 | 30-day Notice |
| S062 | 2018-03-01 | 30-day Notice |
| S061 | 2017-11-14 | 30-day Notice |
| S060 | 2017-09-26 | 30-day Notice |
| S059 | 2017-08-07 | 30-day Notice |
| S058 | 2017-07-14 | 30-day Notice |
| S057 | 2017-07-14 | 30-day Notice |
| S056 | 2017-04-21 | Special (immediate Track) |
| S055 | 2016-09-22 | 30-day Notice |
| S054 | 2016-08-16 | 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 | 2015-11-17 | Real-time Process |
| S048 | 2015-08-31 | Normal 180 Day Track |
| S047 | 2015-04-09 | 30-day Notice |
| S046 | 2015-03-13 | 30-day Notice |
| S045 | 2015-02-25 | Real-time Process |
| S044 | 2014-12-19 | 30-day Notice |
| S043 | 2014-07-28 | 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 | 2014-02-03 | 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 | 2013-07-26 | 30-day Notice |
| S032 | 2013-05-09 | 30-day Notice |
| S031 | 2012-11-16 | Real-time Process |
| S030 | 2012-11-06 | Real-time Process |
| S029 | 2012-09-13 | 30-day Notice |
| S028 | 2012-08-15 | 30-day Notice |
| S027 | 2012-07-02 | Normal 180 Day Track |
| S026 | 2012-05-30 | Real-time Process |
| S025 | 2012-03-29 | Normal 180 Day Track No User Fee |
| S024 | 2011-12-12 | 135 Review Track For 30-day Notice |
| S023 | 2011-09-12 | 30-day Notice |
| S022 | 2011-08-24 | 30-day Notice |
| S021 | 2011-07-01 | Normal 180 Day Track |
| S020 | 2011-05-31 | Normal 180 Day Track No User Fee |
| S019 | ||
| S018 | 2011-04-07 | Special (immediate Track) |
| S017 | 2011-03-01 | 30-day Notice |
| S016 | 2011-03-01 | 135 Review Track For 30-day Notice |
| S015 | 2011-02-08 | 30-day Notice |
| S014 | 2010-08-25 | 30-day Notice |
| S013 | ||
| S012 | 2010-08-05 | 30-day Notice |
| S011 | ||
| S010 | 2010-05-03 | 30-day Notice |
| S009 | 2010-03-01 | 30-day Notice |
| S008 | 2010-01-08 | 30-day Notice |
| S007 | 2009-12-24 | 30-day Notice |
| S006 | 2009-12-22 | Normal 180 Day Track |
| S005 | 2009-09-15 | 30-day Notice |
| S004 | 2009-07-02 | 30-day Notice |
| S003 | 2009-04-28 | 30-day Notice |
| S002 | 2008-12-05 | 30-day Notice |
| S001 | 2008-11-14 | 30-day Notice |