Approval for the advia centaur hbc igm. Hbc igm ready pack reagents: this device is indicated for use for the advia centaur hbc igm assay and is an in vitro diagnostic test for the qualitative determination if igm response to hepatitis b virus core antigen in human serum and plasma (edta or lithium or sodium heparinized) using the advia centaur system. The assay uses recombinant hbc antigen. This assay may be used in combination with other hepatitis b virus (hbv) market assays to define the clinical status of known hbv infected patients or can be combined with other hbv, hav (hepatitis a virus), and hcv (hepatitis c virus) assays for the diagnosis of patients presenting symptoms of acute viral hepatitis. Assay performance characteristics have not been established for immunocompro-mised or immunosuppressed patients, cord blood, neonatal specimens, infants or children. Assay performance characteristics have not been established when the advia centaur hbc igm assay is used in conjunction with other manufacturers' assays for specific hbv serological markers. Hbc igm quality control materials: the controls are indicated for in vitro diagnostic use in monitoring the performance of the hbc igm assay on the adviua centaur systems. The performance of the hbc igm quality control material has not been established with any other anti-hbc igm assays.
| Device | ADVIA CENTAUR HBC IGM READYPACK REAGENTS, ADVIA CENTAUR HBC IGM 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 | 2003-09-11 |
| Decision Date | 2004-08-06 |
| Notice Date | 2005-05-02 |
| PMA | P030040 |
| Supplement | S |
| Product Code | LOM |
| Docket Number | 05M-0158 |
| 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 |
|---|
| P030040 | | 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 |
2018-08-15 |
Normal 180 Day Track No User Fee |
| S013 |
2018-07-19 |
Real-time Process |
| S012 |
2017-06-16 |
Normal 180 Day Track |
| S011 |
2016-07-05 |
Normal 180 Day Track |
| S010 |
2015-06-11 |
30-day Notice |
| S009 |
2015-05-14 |
Normal 180 Day Track |
| S008 |
2012-03-26 |
Normal 180 Day Track No User Fee |
| S007 |
2010-02-18 |
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 |
2008-08-11 |
Normal 180 Day Track |
| S001 | | |
NIH GUDID Devices