Approval for adding advia centaur xp instrument to the intended use of theapproved device advia centaur hcv assay. The device, as modified, will be marketed under the trade name advia centaur hcv assay and is indicated for:advia centaur hcv assay:the 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 heparin) using the advia centaur and advia centaur xp systems. The assay may be used in conjunction with other serological and clinical information to aid in the diagnosis of individuals with symptoms of hepatitis and in individuals at risk for hepatitis c infection. Advia centaur hcv quality controls:for in vitro diagnostic use in monitoring the performance of the hcv assay on theadvia centaur systems. The performance of the hcv quality control material has notbeen established with any other anti-hcv assays.
| Device | ADVIA CENTAUR HCV READYPACK REAGENNTS/QUALITY CONTROL MATERIALS |
| Classification Name | Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus |
| Generic Name | Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS |
| Date Received | 2009-03-09 |
| Decision Date | 2009-04-09 |
| PMA | P030056 |
| Supplement | S004 |
| Product Code | MZO |
| Advisory Committee | Microbiology |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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