|Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.|
|Trade Name||ABBOTT ARCHITECT CORE ASSAY|
|Classification Name||test, hepatitis b (b core, be antigen, be antibody, b core igm)|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - software|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for migration of the architect® core¿ assay to a new architect® i system family member, the architect® i 1000sr. The architect core reagent kit device is indicated for: the architect core assay is a chemiluminescent microparticle immunoassay (cmia) for the qualitative detection of igg and igm antibodies to hepatitis b core antigen (anti-hbc) in human adult and pediatric serum and plasma (dipotassium edta, lithium heparin, sodium heparin) and neonatal serum. It is intended as an aid in the diagnosis of acute, chronic, or resolved hepatitis b virus (hbv) infection in conjunction with other laboratory results and clinical information.