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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 HBSAG IMMUNOASSAY, ELECSYS HBSAG CONFIRMATORY, AND PRECICONTROL HBSAG
Generic NameTest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantROCHE DIAGNOSTICS CORP.
9115 HAGUE ROAD
P.O. BOX 50416
INDIANAPOLIS, IN 46250-0457
PMA NumberP990012
Date Received03/04/1999
Decision Date06/01/2001
Withdrawal Date 05/05/2021
Product Code LOM 
Docket Number 01M-0507
Notice Date 11/14/2001
Advisory Committee Microbiology
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ELECSYS. HBSAG IMMUNOASSAY, ELECSYS HBSAG CONFIRMATORY, AND PRECICONTROL HBSAG. THE DEVICES ARE INDICATED FOR: ELECSYS HBSAG IMMUNOASSAY IS AN IMMUNOASSAY FOR THE IN VITRO QUALITATIVE DETECTION OF HEPATITIS B SURFACE ANTIGEN (HBSAG) IN HUMAN SERUM AND PLASMA (HEPARIN, EDTA-K3, SODIUM CITRATE). ASSAY RESULTS IN CONJUNCTION WITH OTHER SEROLOGICAL AND CLINICAL INFORMATION, MAY BE USED FOR THE LABORATORY DIAGNOSIS OF INDIVIDUALS WITH ACUTE OR CHRONIC HEPATITIS B. IN ADDITION, THIS ASSAY MAY BE USED TO SCREEN FOR HEPATITIS B INFECTION IN PREGNANT WOMEN TO IDENTIFY NEONATES WHO ARE AT HIGH RISK OF ACQUIRING HBV DURING THE PERINATAL PERIOD. THE ELECTROCHEMILUMINESCENCE IMMUNOASSAY "ECLIA" IS INTENDED FOR USE ON THE ROCHE ELECSYS 2010 IMMUNOASSAY SYSTEM. ELECSYS HBSAG CONFIRMATORY IS AN IMMUNOASSAY FOR THE IN VITRO QUALITATIVE CONFIRMATION OF THE PRESENCE OF HEPATITIS B SURFACE ANTIGEN IN HUMAN SERUM AND PLASMA (HEPARIN, EDTA-K3, SODIUM CITRATE) SAMPLES REPEATEDLY REACTIVE WHEN TESTED WITH ELECSYS 2010 HBSAG IMMUNOASSAY. PRECICONTROL HBSAG IS USED FOR QUALITY CONTROL OF THE ELECSYS HBSAG IMMUNOASSAY ON THE ELECSYS 2010 IMMUNOASSAY SYSTEM WHEN TESTING HUMAN SERUM. THE PERFORMANCE OF THE PRECICONTROL HBSAG HAS NOT BEEN ESTABLISHED WITH ANY OTHER HBSAG ASSAY.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements: S009 S010 S011 S012  S001 S023 S019 S006 S005 S003 S002 
S024 S025 S008 S014 S020 S016 S017 S018 S022 S013 S021 S007 
S026 S027 S031 S032 S028 S029 S033 
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