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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 HBSAGII
Generic NameTest, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Regulation Number866.3172
ApplicantSiemens Corp.
511 Benedict Ave.
New York, NY 10591
PMA NumberP110041
Date Received12/19/2011
Decision Date05/16/2014
Reclassified Date10/20/2025
Product Code LOM 
Docket Number 14M-0692
Notice Date 06/10/2014
Advisory Committee Microbiology
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE ADVIA CENTAUR HBSAGII, ADVIA CENTAUR HBSAG CONFIRMATORY, AND ADVIA CENTAUR HBSAG QUALITYCONTROL MATERIAL. THIS DEVICE IS INDICATED FOR:ADVIA CENTAUR HBSAGII (HBSII) -THE ADVIA CENTAUR HBSAGII (HBSII) ASSAY IS AN IN VITRO IMMUNOASSAY FOR THE QUALITATIVEDETECTION OF HEPATITIS B SURFACE ANTIGEN (HBSAG) IN HUMAN ADULT, ADOLESCENT, AND PEDIATRIC SERUM AND PLASMA (EDT A, LITHIUM-HEPARIN, OR SODIUM-HEPARIN), AND NEONATAL SAMPLES USINGTHE ADVIA CENTAUR AND ADVIA CENTAUR XP SYSTEMS. THE ASSAY MAY BE USED IN CONJUNCTIONWITH OTHER SEROLOGICAL AND CLINICAL INFORMATION TO DIAGNOSE INDIVIDUALS WITH ACUTE OR CHRONICHEPATITIS B INFECTION. THE ASSAY MAY ALSO BE USED TO SCREEN FOR HEPATITIS B INFECTION IN PREGNANT WOMEN TO IDENTIFY NEONATES WHO ARE AT RISK OF ACQUIRING HEPATITIS B DURING THE PERINATAL PERIOD.ADVIA CENTAUR HBSAG CONFIRMATORYTHE ADVIA CENTAUR HBSAG CONFIRMATORY ASSAY IS AN IN VITRO IMMUNOASSAY FOR THE CONFIRMATION OF HEPATITIS B SURFACE ANTIGEN (HBSAG) IN HUMAN SERUM AND PLASMA (POTASSIUMEDTA, LITHIUM-HEPARIN, OR SODIUM-HEPARIN), AND NEONATAL SAMPLES USING THE ADVIA CENTAUR AND ADVIA CENTAUR XP SYSTEMS. THE ASSAY IS INTENDED TO BE USED TO CONFIRM THE PRESENCE OFHBSAG IN SAMPLES THAT ARE REPEATEDLY REACTIVE USING THE ADVIA CENTAUR HBSAGII ASSAY.ADVIA CENTAUR HBSAG QUALITY CONTROL MATERIALFOR MONITORING THE PERFORMANCE OF THE HBSAG, HBSAGII AND HBSAG CONFIRMATORY ASSAYS ON THE ADVIA CENTAUR SYSTEMS. THE PERFORMANCE OF THE HBSAG QUALITY CONTROL MATERIAL HAS NOT BEEN ESTABLISHED WITH ANY OTHER HBSAG OR HBSAG CONFIRMATORY ASSAYS.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S003 S005 S012 S015 S016 S006 S004 S009 S007 
S010 S008 S013 S011 S017 S014 
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