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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameARCHITECT HBSAG REAGENT KIT, CALIBRATORS, CONTROLS, CONFIRMATORY REAGENT KIT, CONFIRMATORY MANUAL DILUENT
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantABBOT LABORATORIES
PMA NumberP060007
Date Received02/24/2006
Decision Date09/07/2006
Product Code
LOM[ Registered Establishments with LOM ]
Docket Number 07M-0152
Notice Date 04/29/2007
Advisory Committee Microbiology
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the architect hbsag reagents, architect hbsag calibrators, architect hbsag controls, architect hbsag confirmatory reagents, and architect hbsag confirmatory manual diluent. The architect hbsag assay is a chemiluminescent microparticle immunoassay (cmia) for the qualitative detection of hepatitis b surface antigen (hbsag) in human adult and pediatric serum and plasma (dipotassium edta). The assay may also be used to screen for hbv infection in pregnant females to identify neonates who are at risk of acquiring hepatitis b during the perinatal period. Assay results, in conjunction with other laboratory results and clinical information, may be used to provide presumptive evidence of infection with the hepatitis b virus (hbv) (state of infection or associated disease not determined) in persons with signs and symptoms of hepatitis and in persons at risk for hepatitis b infection. The architect hbsag calibrators are used for calibration of the architect i system when the system is used for the qualitative detection of hepatitis b surface antigen (hbsag) using the architect hbsag and hbsag confirmatory reagent kits. The performance of the architect hbsag calibrators has not been established with any other hbsag assays. (continued. ).
Approval Order Approval Order
Supplements: S001 S002 S003 S004 S005 S006 
S007 S008 S009 S010 S011 S012 
S013 S014 S015 S016 S017 S018 
S019 S020 S021 S022 S023 S024 
S025 S026 
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