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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-HBS
Generic NameTest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantROCHE DIAGNOSTICS CORP.
9115 HAGUE RD.
INDIANAPOLIS, IN 46250
PMA NumberP010054
Date Received09/10/2001
Decision Date02/28/2002
Product Code LOM 
Docket Number 02M-0179
Notice Date 04/25/2002
Advisory Committee Microbiology
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ELECSYS ANTI-HBS IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBS. THE ELECSYS ANTI-HBS IMMUNOASSAY IS INDICATED FOR: THE QUALITATIVE DETERMINATION OF TOTAL ANTIBODIES TO THE HEPATITIS B SURFACE ANTIGEN (HBSAG) IN HUMAN SERUM AND PLASMA (EDTA). THE ELECTROCHEMILUMIN-ESCENCE IMMUNOASSAY "ECLIA" IS INTENDED FOR USE ON THE ROCHE ELECSYS 2010 IMMUNOASSAY ANALYZER. ASSAY RESULTS MAY BE USED AS AN AID IN THE DETERMINATION OF SUSCEPTIBILITY TO HEPATITIS B VIRUS (HBV) INFECTION FOR 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. THE DETECTION OF ANTI-HBS IS INDICATIVE OF LABORATORY DIAGNOSIS OF SEROCONVERSION FROM HEPATITIS B VIRUS (HBV) INFECTION. THE ELECSYS PRECICONTROL ANTI-HBS IS INDICATED FOR: THE PRECICONTROL ANTI-HBS IS USED FOR QUALITY CONTROL OF THE ELECSYS ANTI-HBS IMMUNOASSAY ON THE ELECSYS 2010 IMMUNOASSAY ANALYZER. THE PERFORMANCE OF THE PRECICONTROL ANTI-HBS HAS NOT BEEN ESTABLISHED WITH ANY OTHER ANTI-HBS ASSAY.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S003 S004 S005 S007 S008 S009 S010 S011 S012 
S013 S014 S015 S016 S017 S018 S019 S021 S022 S023 S024 S025 
S026 S027 S028 S029 S030 S031 S032 S034 S035 S036 S037 S038 
S039 S040 S041 S042 S043 S044 S045 
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