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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.
 
DeviceELECSYS ANTI-HBC IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HBC FOR USE ON THE ELECSYS 2010 IMMUNOASSAY ANALYZER
Generic NameTest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantROCHE DIAGNOSTICS CORP.
9115 HAGUE RD.
INDIANAPOLIS, IN 46250
PMA NumberP100032
Date Received07/30/2010
Decision Date06/27/2011
Product Code LOM 
Docket Number 11M-0503
Notice Date 07/01/2011
Advisory Committee Microbiology
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ELECSYS ANTI-HBC IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HBC FOR USE ON THE ELECSYS 2010 IMMUNOASSAY ANALYZER. THIS DEVICE IS INDICATED FOR THE IN VITRO QUALITATIVE DETERMINATION OF TOTAL ANTIBODIES TO HEPATITIS B CORE ANTIGEN (ANTI-HBC) IN HUMAN SERUM AND PLASMA (LITHIUM-HEPARIN, SODIUM-CITRATE, K2-EDTA) IN ADULT PATIENTS WITH THE SYMPTOMS OF HEPATITIS OR WHO MAY BE AT RISK FOR HEPATITIS B (HBV) INFECTION. THE DETECTION OF TOTAL ANTI-HBC IS INDICATIVE OF A LABORATORY DIAGNOSIS FOR HBV INFECTION. FURTHER HBV SEROLOGICAL MARKER TESTING IS REQUIRED TO DEFINE THE SPECIFIC DISEASE STATE. THE ELECSYS ANTI-HBC IMMUNOASSAY'S PERFORMANCE HAS NOT BEEN ESTABLISHED FOR THE MONITORING OF HBV DISEASE OR THERAPY. THE ELECTROCHEMILUMI-NESCENCE IMMUNOASSAY ECLIA IS INTENDED FOR USE ON THE ELECSYS 2010 IMMUNOASSAY ANALYZER. THE ELECSYS PRECICONTROL ANTI-HBC IS USED FOR QUALITY CONTROL OF THE ELECSYS ANTI-HBC IMMUNOASSAY ON THE ELECSYS 2010 IMMUNOASSAY ANALYZER.
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 
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