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 the extension of the elecsys anti-hcv immunoassay andprecicontrol anti-hcv immunoassay onto the cobas e 602 immunoassay analyzer. The device, as modified, will be marketed under the trade name elecsys anti-hcv immunoassay and is indicated for: elecsys anti-hcv immunoassay - the elecsys anti-hcv immunoassay is an in vitro diagnostic test for the qualitativedetection of total antibodies to hepatitis c virus (anti-hcv) in human serum or plasma (potassium edta, lithium heparin and sodium heparin). Assay results, in conjunction with other laboratory results and clinical information, may be used to aid in the presumptive diagnosis of hcv infection in persons with signs and symptoms of hepatitis and in persons at risk for hepatitis c infection. This test does not determine the state of infection or associated disease. The electrochemiluminescence immunoassay "eclia" is intended for use on cobas e 601 and cobas e 602 immunoassay analyzers.
| Device | ELECSYS ANTI-HCV IMMUNOASSAY |
| Classification Name | Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus |
| Generic Name | Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus |
| Applicant | ROCHE DIAGNOSTICS CORP. |
| Date Received | 2011-11-01 |
| Decision Date | 2012-04-25 |
| PMA | P090008 |
| Supplement | S006 |
| Product Code | MZO |
| 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 DIAGNOSTICS CORP. 9115 Hague Rd. indianapolis, IN 46250 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P090008 | Original Filing | |
| S023 | 2022-09-30 | Real-time Process |
| S022 | ||
| S021 | 2018-10-26 | Normal 180 Day Track No User Fee |
| S020 | 2018-04-17 | Real-time Process |
| S019 | 2017-10-11 | Real-time Process |
| S018 | 2017-08-03 | 30-day Notice |
| S017 | 2016-02-16 | 30-day Notice |
| S016 | 2016-01-27 | 30-day Notice |
| S015 | 2015-10-07 | 30-day Notice |
| S014 | 2014-08-22 | 30-day Notice |
| S013 | 2014-04-04 | Real-time Process |
| S012 | 2012-11-30 | 30-day Notice |
| S011 | 2012-09-05 | 30-day Notice |
| S010 | ||
| S009 | 2012-02-29 | 30-day Notice |
| S008 | 2012-01-31 | 135 Review Track For 30-day Notice |
| S007 | 2011-11-21 | 30-day Notice |
| S006 | 2011-11-01 | Normal 180 Day Track |
| S005 | 2011-08-29 | 135 Review Track For 30-day Notice |
| S004 | 2011-08-17 | 135 Review Track For 30-day Notice |
| S003 | 2011-05-17 | Normal 180 Day Track No User Fee |
| S002 | 2011-04-11 | 30-day Notice |
| S001 | 2010-07-28 | Normal 180 Day Track |