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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 IGM IMMUNOASSAY & ELECSYS PREICONTROL ANTI-HBC IGM FOR USE ON THE MODULAR ANAYTICS E170 IMMUNOASSAY ANA
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 NumberP110025
Date Received06/23/2011
Decision Date12/14/2011
Product Code LOM 
Docket Number 11M-0917
Notice Date 12/21/2011
Advisory Committee Microbiology
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ELECSYS ANTI-HBC IGM IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBC IGM FOR USE ON THE MODULAR ANAL YTICS E170 IMMUNOASSAY ANALYZER. THIS DEVICE IS INDICATED FOR:THE ELECSYS ANTI-HBC IGM IMMUNOASSAY IS INTENDED FOR THE IN VITRO QUALITATIVE DETERMINATION OF IGM ANTIBODIES TO HEPATITIS B CORE ANTIGEN (ANTI-HBC IGM) IN HUMANSERUM OR PLASMA (POTASSIUM EDTA, LITHIUM HEPARIN, SODIUM HEPARIN, SODIUM CITRATE) IN ADULT PATIENTS WITH SYMPTOMS OF HEPATITIS OR WHO MAY BE AT RISK FOR HEPATITIS B (HBV)INFECTION. THE PRESENCE OF ANTI-HBC IGM, IN CONJUNCTION WITH OTHER LABORATORY RESULTS AND CLINICAL INFORMATION, IS INDICATIVE OF ACUTE OR RECENT HEPATITIS B VIRUS (HBV) INFECTION. THE ELECSYS ANTI-HBC IGM IMMUNOASSAY'S PERFORMANCE HAS NOT BEEN ESTABLISHED FOR THE MONITORING OF HBV DISEASE OR THERAPY. THE ECTROCHEMILUMINESCENCE IMMUNOASSAY "ECLIA" IS INTENDED FOR USE ON THE MODULAR ANAL YTICS E170 IMMUNOASSAY ANALYZER. ELECSYS PRECICONTROL ANTI-HBC IGM IS USED FOR QUALITY CONTROL OF THE ELECSYS ANTI-HBCIGM IMMUNOASSAY ON THE MODULAR ANAL YTICS E170 IMMUNOASSAY ANALYZER.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S003 S004 S005 S006 S008 S010 S011 S012 S013 
S014 S015 S016 S017 S018 S019 S020 S021 S022 S023 
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