Approval for the claim to test a pediatric population with the fda approved advia centaur hcv readypack reagents and advia centaur hcv quality control materials. The device, as modified, will be marketed under the trade name advia centaur hcv readypack reagents and advia centaur hcv quality control materials and is indicated for:advia centaur and advia centaur xp systems. The advia centaur hcv (ahcv) assay is an in vitro diagnostic immunoassay for the qualitative determination of immunoglobulin g (igg) antibodies to hepatitis c virus (hcv) in human pediatric (18 months ¿ 21 years) and adult serum and plasma (edta, lithium or sodium heparinized) 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 cp system: the advia centaur hcv (ahcv) assay is an in vitro diagnostic immunoassay for the qualitative determination of immunoglobulin g (igg) antibodies to hepatitis c virus (hcv) in human pediatric (18 months ¿ 21 years) and adult 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 the diagnosis of individuals with symptoms of hepatitis and in individuals at risk for hepatitis c infection.
| Device | ADVIA CENTAUR HCV READYPACKS |
| Classification Name | Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus |
| Generic Name | Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS |
| Date Received | 2014-09-15 |
| Decision Date | 2015-03-10 |
| PMA | P030056 |
| Supplement | S008 |
| Product Code | MZO |
| Advisory Committee | Microbiology |
| Supplement Type | Normal 180 Day Track |
| 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