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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceABBOTT ARCHITECT AUSAB
Generic NameTest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantABBOTT LABORATORIES INC
100 ABBOTT PARK ROAD
DEPT 9VA- AP8-1
ABBOTT PARK, IL 60064
PMA NumberP050051
Date Received12/09/2005
Decision Date06/01/2006
Product Code LOM 
Docket Number 06M-0321
Notice Date 08/17/2006
Advisory Committee Microbiology
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE ARCHITECT AUSAB REAGENT KIT, WHICH IS INDICATED FOR: ARCHITECT AUSAB REAGENT KIT: THE ARCHITECT AUSAB ASSAY IS A CHEMILUMINESCENT MICROPARTICLE IMMUNOASSAY (CMIA) FOR THE QUANTITATIVE DETERMINATION OF ANTIBODY TO HEPATITIS B SURFACE ANTIGEN (ANTI-HBS) IN HUMAN ADULT AND PEDIATRIC SERUM AND PLASMA (DIPOTASSIUM EDTA, LITHIUM HEPARIN, AND SODIUM HEPARIN) AND NEONATAL SERUM. IT IS INTENDED FOR QUANTITATIVE MEASUREMENT OF ANTIBODY RESPONSE FOLLOWING HEPATITIS B VIRUS (HBV) VACCINATION, DETERMINATION OF HBV IMMUNE STATUS, AND FOR THE LABORATORY DIAGNOSIS OF HBV DISEASE ASSOCIATED WITH HBV INFECTION WHEN USED IN CONJUNCTION WITH OTHER LABORATORY RESULTS AND CLINICAL INFORMATION. ARCHITECT AUSAB CALIBRATORS: THE ARCHITECT AUSAB CALIBRATORS ARE USED TO CALIBRATE THE ARCHITECT I SYSTEM WHEN THE SYSTEM IS USED FOR THE QUANTITATIVE DETERMINATION OF ANTIBODY TO HEPATITIS B SURFACE ANTIGEN (ANTI-HBS) USING THE ARCHITECT AUSAB REAGENT KIT. THE PERFORMANCE OF THE ARCHITECT AUSAB CALIBRATORS HAS NOT BEEN ESTABLISHED WITH ANY OTHER ANTI-HBS ASSAYS. ARCHITECT AUSAB CONTROLS: THE ARCHITECT AUSAB CONTROLS ARE USED FOR MONITORING THE PERFORMANCE OF THE ARCHITECT I SYSTEM WHEN USED FOR THE QUANTITATIVE DETERMINATION OF ANTIBODY TO HEPATITIS B SURFACE ANTIGEN (ANTI-HBS) USING THE ARCHITECT AUSAB REAGENT KIT. THE PERFORMANCE OF THE ARCHITECT AUSAB CONTROLS HAS NOT BEEN ESTABLISHED WITH ANY OTHER ANTI-HBS ASSAYS.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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 S027 S028 S029 S030 S031 S032 S033 S034 S035 
S036 S037 S038 S039 S040 S041 S042 S043 S044 S045 S046 S047 
S048 S049 S050 S051 S052 S054 S055 S056 S057 S058 S059 S060 
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