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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.
 
DeviceARCHITECT CORE REAGENT KIT, ARCHITECT CORE CALIBRATOR AND ARCHITECT CORE CONTROLS
Generic NameTest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantAbbott Laboratories
100 ABBOTT PARK RD.
AP5N-2, DEPT. 09VB
ABBOTT PARK, IL 60064
PMA NumberP080023
Date Received08/28/2008
Decision Date04/10/2009
Product Code LOM 
Docket Number 09M-0244
Notice Date 05/27/2009
Advisory Committee Microbiology
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ARCHITECT CORE REAGENT KIT, ARCHITECT CORE CALIBRATOR AND ARCHITECT CORE CONTROLS. THESE DEVICES ARE INDICATED FOR:ARCHITECT CORE REAGENT KIT:THE ARCHITECT CORE ASSAY IS A CHEMILUMINESCENT MICROPARTICLE IMMUNOASSAY(CMIA) FOR THE QUALITATIVE DETECTION OF IGG AND IGM ANTIBODIES TO HEPATITIS B COREANTIGEN (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.ARCHITECT CORE CALIBRATOR:THE ARCHITECT CORE CALIBRATOR IS USED FOR THE CALIBRATION OF THE ARCHITECT ISYSTEM WHEN THE SYSTEM IS USED FOR THE QUALITATIVE DETECTION OF IGG AND IGM ANTIBODIES TOHEPATITIS B CORE ANTIGEN (ANTI-HBC) WITH THE ARCHITECT CORE REAGENT KIT. THE PERFORMANCE OF THE ARCHITECT CORE CALIBRATOR HAS NOT BEEN ESTABLISHED WITH ANY OTHER ANTI-HBC ASSAYS.ARCHITECT CORE CONTROLS:THE ARCHITECT CORE CONTROLS ARC USED FOR MONITORING THE PERFORMANCE OF THE ARCHITECT I SYSTEM WHEN USED FOR THE QUALITATIVE DETECTION OF IGG AND IGM ANTIBODIES TO HEPATITIS B CORE ANTIGEN (ANTI-HBC) WITH THE ARCHITECT CORE REAGENT KIT. THEPERFORMANCE OF THE ARCHITECT CORE CONTROLS HAS NOT BEEN ESTABLISHED WITH ANY OTHERANTI-HBC 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 
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