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 device design modifications to reduce the sample input volume, improve genotype inclusivity, and improve assay sensitivity to 15 iu/ml. The device, as modified, will be marketed under the trade name cobas® ampliprep/cobas® taqman® hcv test, v2. 0 and is indicated for: the cobas® ampliprep/cobas® taqman® hcv test, v2. 0 is an in vitro nucleic acid amplification test for the quantitation of hepatitis c viral (hcv) rna genotypes 1 to 6 in human edta plasma or serum of hcv-infected individuals using the cobas® ampliprep instrument for automated specimen processing and the cobas® taqman® analyzer or the cobas® taqman® 48 analyzer for automated amplification and detection. The test is intended for use inthe management of patients with chronic hcv in conjunction with clinical and laboratory markers of infection. The test can be used to predict the probability of sustained virologic response (svr) early during a course of antiviral therapy, and to assess viral response to antiviral treatment (response guided therapy) as measured by changes of hcv rna levels in serum or edta plasma. 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 state of hcv infection has not been established. The cobas® ampliprep/ cobas® taqman® hcv test is not intended for use as a screening test for the presence of hcv in blood or blood products or as a diagnostic test to confirm the presence of hcv infection.
| Device | COBAS AMPLIPREP/COBAS TAQMAN HCV TEST, V2.0 |
| 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 | 2012-07-02 |
| Decision Date | 2013-02-14 |
| PMA | P060030 |
| Supplement | S027 |
| Product Code | MZP |
| Advisory Committee | Microbiology |
| Supplement Type | Normal 180 Day Track |
| 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 |
|---|---|---|
| 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 |