Approval for the advia centaur hbsag readypack reagents, advia centaur hbsag confirmatory readypack reagents, and advia centaur hbsag quality control material: advia centaur hbsag ready pack indications for use: the advia centaur hbsag assay is an in vitro immunoassay for the qualitative detection of hepatitis b surface antigen (hbsag) in human serum and plasma (potassium edta, lithium or sodium heparinized) using the advia centaur system. The assay may be used in conjunction with other serological and clinical information to diagnose individuals with acute or chronic hepatitis b infections. The assay may also be used to screen for hepatitis b infection in pregnant women to identify neonates who are at risk of acquiring hepatitis b during the perinatal period. Advia centaur hbsag confirmatory ready pack indication for use: the advia centaur hbsag confirmatory assay is an in vitro diagnostic immunoassay for the qualitative confirmation of the presence of hepatitis b surface antigen (hbsag) in human serum or plasma (edta, lithium or sodium heparin) using the advia centaur system. The assay is intended to be used to confirm the presence of hbsag in samples that are repeatedly reactive using the advia centaur hbsag assay. Advia centaur hbsag quality control material indications for use: for monitoring the performance of the hbsag and hbsag confirmatory assays on the advia centaur systems.
| Device | ADVIA CENTAUR HBSAG READY PACK REAGENTS/CONFIRMATORY READY PACK REAGENTS/QUALITY CONTROL MATERIAL |
| 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 | 2003-11-28 |
| Decision Date | 2005-05-26 |
| Notice Date | 2005-07-01 |
| PMA | P030049 |
| Supplement | S |
| Product Code | LOM |
| Docket Number | 05M-0270 |
| 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 |
|---|
| P030049 | | Original Filing |
| S016 |
2020-12-22 |
Real-time Process |
| S015 |
2020-07-31 |
30-day Notice |
| S014 |
2020-02-21 |
30-day Notice |
| S013 |
2019-09-27 |
30-day Notice |
| S012 |
2015-06-11 |
30-day Notice |
| S011 |
2014-07-10 |
Real-time Process |
| S010 |
2012-03-26 |
Normal 180 Day Track No User Fee |
| S009 | | |
| S008 |
2010-04-06 |
30-day Notice |
| S007 |
2009-05-18 |
Normal 180 Day Track |
| S006 |
2009-05-12 |
30-day Notice |
| 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 |
2008-07-30 |
Normal 180 Day Track |
| S001 | | |
NIH GUDID Devices