Approval for adding quantitative determination of total antibodies to hepatitis bsurface antigen in human adult, adolescent, and pediatric serum or plasma to the intended use. The device, as modified, will be marketed under the trade name advia centaur® and adviacentaur® xp anti-hbs assay and is indicated for:the advia centaur anti-hbs assay is an in vitro diagnostic immunoassay for the qualitativeand quantitative determination of total antibodies to hepatitis b surface antigen in human adult, adolescent, and pediatric serum or plasma (edta or heparinized) using the advia centaurand advia centaur xp systems. The assay results may be used as an aid in the determinationof susceptibility to hepatitis b virus (hbv) infection in individuals prior to or following hbvvaccination or where vaccination status is unknown. Assay results may be used with other hbv serological markers for the laboratory diagnosis of hbv disease associated with i hbv infection. A reactive assay result will allow a differential diagnosis in individuals displayingsigns and symptoms of hepatitis in whom etiology is unknown.
| Device | ADVIA CENTAUR ANTI-HBS (AHBS) |
| 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 | 2008-09-18 |
| Decision Date | 2009-06-10 |
| PMA | P030029 |
| Supplement | S004 |
| 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 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P030029 | | Original Filing |
| S013 |
2012-03-26 |
Normal 180 Day Track No User Fee |
| S012 |
2011-02-16 |
30-day Notice |
| S011 |
2010-09-29 |
30-day Notice |
| S010 | | |
| S009 |
2009-09-28 |
Normal 180 Day Track |
| S008 |
2009-08-21 |
30-day Notice |
| S007 |
2009-05-18 |
Normal 180 Day Track |
| S006 |
2009-03-31 |
Normal 180 Day Track |
| S005 |
2009-03-03 |
Normal 180 Day Track No User Fee |
| S004 |
2008-09-18 |
Normal 180 Day Track |
| S003 |
2008-08-11 |
Normal 180 Day Track |
| S002 | | |
| S001 |
2007-03-14 |
135 Review Track For 30-day Notice |
NIH GUDID Devices