Approval for the advia centaur hbsagii, advia centaur hbsag confirmatory, and advia centaur hbsag qualitycontrol material. This device is indicated for:advia centaur hbsagii (hbsii) -the advia centaur hbsagii (hbsii) assay is an in vitro immunoassay for the qualitativedetection of hepatitis b surface antigen (hbsag) in human adult, adolescent, and pediatric serum and plasma (edt a, lithium-heparin, or sodium-heparin), and neonatal samples usingthe advia centaur and advia centaur xp systems. The assay may be used in conjunctionwith other serological and clinical information to diagnose individuals with acute or chronichepatitis 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. Advia centaur hbsag confirmatorythe advia centaur hbsag confirmatory assay is an in vitro immunoassay for the confirmation of hepatitis b surface antigen (hbsag) in human serum and plasma (potassiumedta, lithium-heparin, or sodium-heparin), and neonatal samples using the advia centaur and advia centaur xp systems. The assay is intended to be used to confirm the presence ofhbsag in samples that are repeatedly reactive using the advia centaur hbsagii assay. Advia centaur hbsag quality control materialfor monitoring the performance of the hbsag, hbsagii and hbsag confirmatory assays on the advia centaur systems. The performance of the hbsag quality control material has not been established with any other hbsag or hbsag confirmatory assays.
| Device | ADVIA CENTAUR HBSAGII |
| 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 CORP. |
| Date Received | 2011-12-19 |
| Decision Date | 2014-05-16 |
| Notice Date | 2014-06-10 |
| PMA | P110041 |
| Supplement | S |
| Product Code | LOM |
| Docket Number | 14M-0692 |
| Advisory Committee | Microbiology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | SIEMENS CORP. 511 Benedict Avenue tarrytown, NY 10591 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P110041 | | Original Filing |
| S013 |
2022-03-22 |
30-day Notice |
| S012 |
2021-04-01 |
30-day Notice |
| S011 |
2020-12-22 |
Real-time Process |
| S010 |
2020-07-31 |
30-day Notice |
| S009 |
2020-03-09 |
30-day Notice |
| S008 |
2020-02-21 |
30-day Notice |
| S007 |
2019-02-01 |
30-day Notice |
| S006 |
2018-07-19 |
Real-time Process |
| S005 |
2018-04-24 |
30-day Notice |
| S004 |
2017-07-24 |
Normal 180 Day Track |
| S003 |
2015-07-13 |
Normal 180 Day Track |
| S002 |
2015-06-11 |
30-day Notice |
| S001 |
2014-10-02 |
Real-time Process |
NIH GUDID Devices