Approval for the advia centaur hbc total. Hbc total readypack reagents: the advia centaur hbc total assay is an in vitro diagnostic test for the qualitative determination 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 system. This assay can be used as an aid in the diagnosis of individuals 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 in individuals displaying signs and symptoms of hepatitis in whom etiology is unknown. Hbc total quality control materials: the controls are indicated for in vitro diagnostic use in monitoring the performance of the hbc total assay on the advia centaur systems. The performance of the hbc total quality control material has not been established with any other anti-hbc total assays.
| Device | ADVIA CENTAUR HBC TOTAL READYPACK REAGENTS/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 | 2004-01-30 |
| Decision Date | 2004-12-22 |
| Notice Date | 2005-03-21 |
| PMA | P040004 |
| Supplement | S |
| Product Code | LOM |
| Docket Number | 05M-0109 |
| Advisory Committee | Microbiology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | SIEMENS HEALTHCARE DIAGNOSTICS 333 Coney Street walpole, MA 02032-1516 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
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