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 elecsysanti-hcv immunoassay & elecsys precicontrol anti-hcv assay for use on cobas e 411immunoassay analyzer. This device is indicated for:elecsys anti-hcv immunoassaythe roche elecsys anti-hcv assay 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 withother laboratory results and clinical information, may be used to aid in the presumptivediagnosis of hcv infection in persons with signs and symptoms of hepatitis and in persons at risk for hepatitis c infection. The test does not determine the state of infection or associated disease. The electrochemilumi-nescence immunoassay "eclia" is intended for use on the cobas e411 immunoassay analyzer. Elecsys precicontrol anti-hcvelecsys precicontrol anti-hcv is used for quality control of the elecsys anti-hcv immunoassay on the cobas e 411 immunoassay analyzer.
| Device | ELECSYS ANTI-HCV IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E411 IMMUNOSSAY ANALYZER |
| Classification Name | Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus |
| Generic Name | Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus |
| Applicant | ROCHE DIAGNOSTICS CORP. |
| Date Received | 2009-05-15 |
| Decision Date | 2010-04-29 |
| Notice Date | 2010-06-14 |
| PMA | P090007 |
| Supplement | S |
| Product Code | MZO |
| Docket Number | 10M-0261 |
| Advisory Committee | Microbiology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ROCHE DIAGNOSTICS CORP. 9115 Hague Rd. indianapolis, IN 46250 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P090007 | Original Filing | |
| S020 | 2018-10-26 | Normal 180 Day Track No User Fee |
| S019 | 2018-03-01 | Real-time Process |
| S018 | ||
| S017 | 2017-10-11 | Real-time Process |
| S016 | 2017-08-03 | 30-day Notice |
| S015 | 2016-02-16 | 30-day Notice |
| S014 | 2016-01-27 | 30-day Notice |
| S013 | 2015-10-07 | 30-day Notice |
| S012 | 2014-08-22 | 30-day Notice |
| S011 | 2012-11-30 | 30-day Notice |
| S010 | 2012-09-05 | 30-day Notice |
| S009 | ||
| S008 | 2012-02-29 | 30-day Notice |
| S007 | 2012-01-31 | 135 Review Track For 30-day Notice |
| S006 | 2011-11-21 | 30-day Notice |
| 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 |