Approval for the migration of claims from the fda approved elecsys anti-hcv ii immunoassay and elecsys precicontrol anti-hcv on the cobas e 601 immunoassay analyzer to the cobas e 602 analyzer. The device, as modified, will be marketed under the trade name elecsys anti-hcv ii immunoassay and elecsys precicontrol anti-hcv and is indicated for: elecsys anti-hcv ii immunoassay: immunoassay for the in vitro qualitative detection of antibodies to hepatitis c virus (hcv) in human adult and pediatric (ages 18 months through 21 years) serum and plasma (potassium edta, lithium heparin, sodium heparin, and sodium citrate). 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. The test does not determine the state of infection or associated disease. The electrochemiluminescence immunoassay “eclia” is intended for use on the cobas e 601 and cobas e 602 immunoassay analyzers. Elecsys precicontrol anti-hcv: elecsys precicontrol anti-hcv is used for quality control of the elecsys anti-hcvimmunoassay on the cobas e 601 and cobas e 602 immunoassay analyzers and the elecsys anti-hcv ii immunoassay on the cobas e 601 and cobas e 602 immunoassay analyzers.
| Device | ELECSYS ANTI-HCV II IMMUNOASSAY |
| Classification Name | Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus |
| Generic Name | Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus |
| Applicant | ROCHE DIAGNOSTICS OPERATIONS INC |
| Date Received | 2015-12-17 |
| Decision Date | 2016-04-12 |
| PMA | P140021 |
| Supplement | S002 |
| 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 OPERATIONS INC 9115 Hague Road p.o. Box 50416 indianapolis, IN 46250-0416 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P140021 | | Original Filing |
| S016 |
2018-10-26 |
Normal 180 Day Track No User Fee |
| S015 |
2018-10-09 |
30-day Notice |
| S014 |
2018-04-17 |
Real-time Process |
| S013 |
2018-03-01 |
Real-time Process |
| S012 |
2017-10-11 |
Real-time Process |
| S011 |
2017-08-03 |
30-day Notice |
| S010 |
2017-07-03 |
Normal 180 Day Track |
| S009 |
2017-05-24 |
30-day Notice |
| S008 |
2017-03-21 |
Normal 180 Day Track |
| S007 |
2016-09-30 |
Real-time Process |
| S006 |
2016-02-16 |
30-day Notice |
| S005 |
2016-01-29 |
Normal 180 Day Track |
| S004 |
2016-01-27 |
30-day Notice |
| S003 |
2016-01-27 |
135 Review Track For 30-day Notice |
| S002 |
2015-12-17 |
Normal 180 Day Track |
| S001 |
2015-10-07 |
30-day Notice |
NIH GUDID Devices