|Trade Name||ADVIA CENTAUR HBSAGII|
|Classification Name||test, hepatitis b (b core, be antigen, be antibody, b core igm)|
|Docket Number|| 14M-0692|
|Notice Date|| 06/10/2014|
|Expedited Review Granted?|| No|
||Labeling, Approval Order, Summary of Safety and Effectiveness|
|Approval Order Statement |
Approval for the advia centaur hbsagii, advia centaur hbsag confirmatory, and advia centaur hbsag quality control material. This device is indicated for: advia centaur hbsagii (hbsii) - the advia centaur hbsagii (hbsii) assay is an in vitro immunoassay for the qualitative detection 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 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. 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 the advia centaur hbsag confirmatory assay is an in vitro immunoassay for the confirmation of hepatitis b surface antigen (hbsag) in human serum and plasma (potassium edta, 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 of hbsag in samples that are repeatedly reactive using the advia centaur hbsagii assay. Advia centaur hbsag quality control material for 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.