Approval for adding advia centaur xp instrument to the intended use of theapproved device advia centaur hbc total assay. The device, as modified, will be marketed under the trade name advia centaur hbc total assay and is indicated for: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 and advia centaur xp systems. This assay can be used as an aid in the diagnosis of individuals with acute or chronic hepatitis b virus (hbv) infectionand in the determination of the clinical status of hbv infected individuals in conjunctionwith 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 differentialdiagnosis in individuals displaying signs and symptoms of hepatitis in whom etiology isunknown.
| Device | ADVIA CENTAUR HBC TOTAL READYPACK REAGENTS/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 | 2009-03-09 |
| Decision Date | 2009-04-09 |
| PMA | P040004 |
| 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 |
|---|
| 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