Approval for the transition of the advia centaur hbsag assay and the adviacentaur hbsag confirmatory assay to a new platform in the centaur family of instruments, thecentaur cp. Advia centaur hbsag readypack reagents on the centaur cp analyzer:the advia centaur hbsag assay is an in vitro diagnostic 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 cp system. The assay may be used in conjunction with other serological and clinical information to diagnose individuals with acute or chronic hepatitis b infection. 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. The advia centaur hbsag confirmatory assay readypack on the centaur cp analyzer: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 and plasma (potassium edta, lithium or sodium heparin) using the advia centaur cp system. The assay is intended to be used to confirm the presence ofhbsag in samples that are repeatedly reactive using the advia centaur hbsag assay. Advia centaur hbsag quality controls on the centaur cp analyzer:for monitoring the performance of the hbsag and hbsag confirmatory assays on the advia centaur systems. The performance of the hbsag quality control material hasnot been established with any other hbsag or hbsag confirmatory assays.
| Device | ADVIA CENTAUR HBSAG & CONFIRMATORY ASSAYS |
| 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 | 2008-07-30 |
| Decision Date | 2009-09-25 |
| PMA | P030049 |
| Supplement | S002 |
| 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 02032-1516 |
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