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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 ANTI-HBS2 (AHBS2) ASSAY AND QAULITY CONTROL MATERIAL
Generic NameTest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantSIEMENS HEALTHCARE DIAGNOSTICS INC.
511 BENEDICT AVE.
TARRYTOWN, NY 10591
PMA NumberP100039
Date Received08/17/2010
Decision Date01/20/2012
Product Code LOM 
Docket Number 12M-0075
Notice Date 01/24/2012
Advisory Committee Microbiology
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR ADVIA CENTAUR ANTI-HBS2 (AHBS2) ASSAY AND ADVIA CENTAUR ANTI-HBS2 (AHBS2) QUALITY CONTROL MATERIAL FOR USE ON THE ADVIA CENTAUR AND ADVIA CENTAUR XP SYSTEMS. THIS DEVICE IS INDICATED FOR: ADVIA CENTAUR ANTI-HBS2 (AHBS2) ASSAY, THE ADVIA CENTAUR ANTI-HB2 ASSAY IS AN IN VITRO DIAGNOSTIC IMMUNOASSAY FOR THE QUALITATIVE AND QUANTITATIVE DETERMINATION OF TOTAL ANTIBODIES TO HEPATITIS B SURFACE ANTIGEN IN HUMAN ADULT, ADOLESCENT, AND PEDIATRIC SERUM OF PLASMA (EDTA, LITHIUM-HEPARINIZED, OR SODIUM-HEPARINIZED) AND NEONATAL SAMPLES USING THE ADVIA CENTAUR AND ADVIA CENTAUR XP SYSTEMS. THE ASSAY RESULTS MAY BE USED AS AN AID IN THE DETERMINATION OF SUSCEPTIBILITY TO HEPATITIS B VIRUS (HBV) INFECTION IN INDIVIDUALS PRIOR TO OR FOLLOWING HBV VACCINATION OR WHERE VACCINATION STATUS IS UNKNOWN. ASSAY RESULTS MAY BE USED WITH OTHER HBV SEROLOGICAL MARKERS FOR THE LABORATORY DIAGNOSIS OF HBV DISEASE ASSOCIATED WITH HBV INFECTION. A REACTIVE ASSAY RESULT WILL ALLOW A DIFFERENTIAL DIAGNOSIS IN INDIVIDUALS DISPLAYING SIGNS AND SYMPTOMS OF HEPATITIS IN WHOM ETIOLOGY IS UNKNOWN.THIS ASSAY HAS NOT BEEN FDA-CLEARED OR APPROVED FOR THE SCREENING OF BLOOD OR PLASMA DONORS. ADVIA CENTAUR ANTI-HBS2 (AHBS2) QUALITY CONTROL MATERIAL, FOR IN VITRO DIAGNOSTIC USE IN MONITORING THE PERFORMANCE OF THE ANTI-HBS2 ASSAY ON THE ADVIA CENTAUR SYSTEMS. THE PERFORMANCE OF THE ANTI-HBS2 QUALITY CONTROL MATERIAL 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 
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