Approval for adding advia centaur xp instrument to the intended use of theapproved devices advia centaur hbsag and advia hbsag confirmatory assay. The devices, as modified, will be marketed under the trade name advia centaur hbsag readypackreagents. Advia centaur hbsag readypack confirmatory assay and advia centaur hbsagquality control material are indicated for:advia centaur hbsag readypack reagentsthe 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 heparin) using the advia centaur and advia centaur xp systems. The assay may be used in conjunction with other serological and clinical information to diagnose individuals with acute or chronic hepatitis b infection. This product is not for use for testing or screening pooled samples containing specimens from more than one individual, or otherwise in blood or plasma screening. Advia centaur hbsag readypack confirmatory assay:the advia centaur hbsag confirmatory assay is an in vitro diagnostic immunoassayfor the qualitative confirmation of the presence of hepatitis b surface antigen (hbsag) in human serum and plasma (potassium edta. Lithium or sodium heparin) using theadvia centaur and advia centaur xp systems. The assay is intended to be used to confirm the presence of hbsag in samples that are repeatedly reactive using the adviacentaur assay. Advia centaur hbsag quality control material:for monitoring the performance of the hbsag and hbsag confirmatory assays on the advia centaur systems when using serum.
| Device | ADVIA CENTAUR HBSAG READYPACK REAGENTS / CONFIRMATORY ASSAY/ 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 | 2009-03-09 |
| Decision Date | 2009-04-09 |
| PMA | P030049 |
| 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 |
|---|
| 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