Approval for the transition of the advia centaur hbc total assay to a new platform in the centaur family of instruments, the centaur cp. The device, as modified, will be marketed under the trade name advia centaur hbc total assay and is indicated for:advia centaur hbc total readypack reagents on the centaur cp analyzer:the advia centaur hbc total assay is an in vitro diagnostic test for the qualitativedetermination of total antibodies to the core antigen of the hepatitis b virus (hbc total)in human serum or plasma (potassium edta, or lithium or sodium heparinized) using the advia centaur cp system. This assay can be used as an aid in the diagnosis ofindividuals with acute or chronic hepatitis b virus (hbv) infection and in the determination of the clinical status of hbv infected individuals in conjunction with other hbv serological markers for the laboratory diagnosis of hbv disease associated with hbv infection. This assay can also be used as an aid in the differential diagnosis inindividuals displaying signs and symptoms of hepatitis in whom etiology is unknown. Advia centaur hbc total quality control materials on the centaur cp analyzer:for monitoring the performance of the hbc total assay on the advia centaur systems. The performance of the hbc total quality control material has not beenestablished with any other anti-hbc total assays.
| Device | ADVIA CENTAUR HBC TOTAL READYPACK REAGENTS AND ADVIA CENTAUR HBC TOTAL QUALITY CONTROL MATERIALS |
| Classification Name | Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm) |
| Generic Name | Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm) |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS |
| Date Received | 2008-08-26 |
| Decision Date | 2009-10-20 |
| PMA | P040004 |
| Supplement | S002 |
| Product Code | LOM |
| 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 |
|---|
| P040004 | | Original Filing |
| S021 |
2022-03-22 |
30-day Notice |
| S020 |
2021-04-01 |
30-day Notice |
| S019 |
2020-12-22 |
Real-time Process |
| S018 |
2020-07-31 |
30-day Notice |
| S017 |
2020-03-09 |
30-day Notice |
| S016 |
2020-02-21 |
30-day Notice |
| S015 |
2019-02-01 |
30-day Notice |
| S014 |
2018-07-19 |
Real-time Process |
| S013 |
2017-07-17 |
Normal 180 Day Track |
| S012 |
2015-07-13 |
Normal 180 Day Track |
| S011 |
2015-06-11 |
30-day Notice |
| S010 |
2014-09-09 |
Normal 180 Day Track |
| S009 |
2012-03-26 |
Normal 180 Day Track No User Fee |
| S008 |
2012-01-09 |
30-day Notice |
| S007 |
2010-01-08 |
30-day Notice |
| 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 |
2008-08-26 |
Normal 180 Day Track |
| S001 | | |
NIH GUDID Devices