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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.
 
DeviceAXSYM, AUSAB
Generic NameTest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantABBOTT LABORATORIES INC
100 ABBOTT PARK ROAD
DEPT 9VA- AP5-2
ABBOTT PARK, IL 60064
PMA NumberP060003
Date Received02/10/2006
Decision Date08/07/2006
Withdrawal Date 11/15/2013
Product Code LOM 
Docket Number 07M-0161
Notice Date 04/30/2007
Advisory Committee Microbiology
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE AXSYM AUSAB ASSAY. THE DEVICE IS INDICATED FOR: AXSYM AUSAB REAGENT PACK IS A MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) INTENDED FOR THE QUANTITATIVE DETERMINATION OF ANTIBODY TO HEPATITIS B SURFACE ANTIGEN (ANTI-HBS) IN ADULT AND PEDIATRIC SERUM (INCLUDING SERUM COLLECTED IN SERUM SEPARATOR TUBES) OR PLASMA (COLLECTED IN SODIUM HEPARIN). THE ASSAY IS USED FOR THE QUANTITATIVE MEASUREMENT OF ANTIBODY RESPONSE TO HEPATITIS B VIRUS (HBV) VACCINATION FOR THE DETERMINATION OF HBV IMMUNE STATUS, AND FOR THE DIAGNOSIS OF HBV DISEASE ASSOCIATED WITH HBV INFECTION WHEN USED IN CONJUNCTION WITH OTHER LABORATORY RESULTS AND CLINICAL INFORMATION. THE AXSYM AUSAB STANDARD CALIBRATORS ARE USED FOR THE CALIBRATION OF THE AXSYM SYSTEM WHEN THE SYSTEM IS USED FOR THE QUANTITATIVE DETERMINATION OF ANTIBODY TO HEPATITIS B SURFACE ANTIGEN (ANTI-HBS) USING THE AXSYM AUSAB REAGENT PACK. THE PERFORMANCE OF THE AXSYM AUSAB STANDARD CALIBRATORS HAS NOT BEEN ESTABLISHED WITH ANY OTHER ANTI-HBS ASSAYS. THE AXSYM AUSAB CONTROLS ARE USED FOR MONITORING THE PERFORMANCE OF THE AXSYM SYSTEM (REAGENT, CALIBRATORS, AND INSTRUMENT) WHEN USED FOR THE QUANTITATIVE DETERMINATION OF ANTIBODY TO HEPATITIS B SURFACE ANTIGEN (ANTI-HBS) WHEN USING THE AXSYM AUSAB REAGENT PACK. THE PERFORMANCE OF THE AXSYM 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 
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