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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.
 
DeviceADVIA CENTAUR HBEAG ASSAY AND QUALITY CONTROL MATERIAL
Generic NameTest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantSIEMENS HEALTHCARE DIAGNOSTICS
511 Benedict Avenue
Tarrytown, NY 10591
PMA NumberP090024
Date Received10/22/2009
Decision Date10/11/2011
Product Code LOM 
Docket Number 11M-0737
Notice Date 10/20/2011
Advisory Committee Microbiology
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR ADVIA CENTAUR HBEAG ASSAY & ADVIA CENTAUR HBEAG QUALITY CONTROL MATERIAL. THIS DEVICE IS INDICATED FOR:ADVIA CENTAUR HBEAG ASSAY:THE ADVIA CENTAUR HBEAG ASSAY IS AN IN-VITRO DIAGNOSTIC IMMUNOASSAY FOR THE QUALITATIVE DETERMINATION OF THE HEPATITIS B E ANTIGEN (HBEAG) IN HUMAN SERUM AND PLASMA (POTASSIUM EDTA, LITHIUM OR SODIUM HEPARIN) FROM INDIVIDUALS WHO HAVE SIGNS ANDSYMPTOMS OF HEPATITIS OR WHO MAY BE AT RISK FOR HEPATITIS B VIRUS (HBV) INFECTION USING THE ADVIA CENTAUR AND ADVIA CENTAUR XP SYSTEMS. THIS ASSAY, IN CONJUNCTION WITH OTHER SEROLOGICAL AND CLINICAL INFORMATION, IS INTENDED ONLY FOR THE DETERMINATION OF CHRONIC INFECTION WITH HEPATITIS B VIRUS.ADVIA CENTAUR HBEAG QUALITY CONTROL MATERIAL:THE CONTROLS ARE USED FOR MONITORING THE PERFORMANCE OF THE HBEAG ASSAY ON THE ADVIA CENTAUR SYSTEMS. THE PERFORMANCE OF THE HBEAG QUALITY CONTROL MATERIAL HAS NOT BEEN ESTABLISHED WITH ANY OTHER HBEAG ASSAY.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
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