Approval for adding advia centaur xp instrument to the intended use of the approved device advia centaur hbc igm assay. The device, as modified, will be marketedunder the trade name advia centaur hbc igm assay and is indicated for:the advia centaur hbc igm assay is an in vitro diagnostic test for the qualitativedetermination of igm response to hepatitis b virus core antigen in human serum andplasma (edta or lithium or sodium heparinized) using the advia centaur and adviacentaur xp systems. The assay uses recombinant hbc antigen. This assay may be used in combination with other hepatitis b virus (hbv) marker assays to define the clinical status of known hbv infected patients or can be combined with other hbv. Hav (hepatitis avirus), 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 orimmunosuppressed 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.
| Device | ADVIA CENTAUR HBC IGM READYPACK REAGENTS/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 | 2009-03-09 |
| Decision Date | 2009-04-09 |
| PMA | P030040 |
| Supplement | S004 |
| Product Code | LOM |
| 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 |
|---|
| 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