Approval for the transition of the advia centaur hcv assay to a new platform in the centaur family of instruments, the centaur cp. Advia centaur hcv readypack reagents on the centaur cp analyzerthe advia centaur hcv assay is an in vitro diagnostic immunoassay for the qualitativedetermination of immunoglobulin g (igg) antibodies to hepatitis c virus (hcv) in human serum and plasma (edta, lithium or sodium heparinized) using the advia centaur cp system. The assay may be used in conjunction with other serological and clinical information to aid in thediagnosis of individuals with symptoms of hepatitis and in individuals at risk for hepatitis cinfection. Advia centaur hcv quality controls on the centaur cp analyzerthe advia centaur hcv quality controls are intended for in vitro diagnostic use inmonitoring the performance of the hcv assay on the advia centaur systems. The performance of the hcv quality controls has not been established with any other anti-hcv assay.
| Device | ADVIA CENTAUR HCV ON CENTAUR CP |
| Classification Name | Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus |
| Generic Name | Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS |
| Date Received | 2008-08-25 |
| Decision Date | 2009-08-13 |
| PMA | P030056 |
| 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 | SIEMENS HEALTHCARE DIAGNOSTICS 333 Coney Street walpole, MA 02032-1516 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P030056 | | Original Filing |
| S020 |
2021-04-01 |
30-day Notice |
| S019 |
2020-12-22 |
Real-time Process |
| S018 |
2020-07-31 |
30-day Notice |
| S017 |
2020-05-22 |
30-day Notice |
| S016 |
2020-03-09 |
30-day Notice |
| S015 |
2020-02-21 |
30-day Notice |
| S014 |
2019-02-01 |
30-day Notice |
| S013 |
2018-07-19 |
Real-time Process |
| S012 | | |
| S011 |
2017-09-29 |
Normal 180 Day Track |
| S010 |
2015-06-11 |
30-day Notice |
| S009 |
2015-05-01 |
Normal 180 Day Track |
| S008 |
2014-09-15 |
Normal 180 Day Track |
| S007 |
2012-03-26 |
Normal 180 Day Track No User Fee |
| S006 |
2009-05-18 |
Normal 180 Day Track |
| S005 |
2009-03-31 |
Normal 180 Day Track |
| S004 |
2009-03-09 |
Normal 180 Day Track No User Fee |
| S003 |
2009-02-04 |
30-day Notice |
| S002 |
2008-08-25 |
Normal 180 Day Track |
| S001 | | |
NIH GUDID Devices