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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 AND ELECSYS PRECICONTROL ANTI-HBC IGM
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
Generic Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
Applicant
ROCHE DIAGNOSTICS CORP.
9115 hague road
p.o. box 50416
indianapolis, IN 46250-0457
PMA NumberP110022
Date Received05/09/2011
Decision Date10/26/2011
Product Code
LOM[ Registered Establishments with LOM ]
Docket Number 11M-0786
Notice Date 11/04/2011
Advisory Committee Immunology
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR THE ELECSYS ANTI-HBC IGM IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBC IGM FOR USE ON THE COBAS E 601 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 HUMAN SERUM 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 (1IBV) INJECTION. 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 ELECTROCHEMILU-MINESCENCE IMMUNOASSAY "ECLIA" IS INTENDED FOR USE ON THE COBAS E 601 IMMUNOASSAY ANALYZER. PRECICONTROI ANTI-HBC IGM ELECSYS PRECICONTROL ANTI-HBC IGM IS USED FOR QUALITY CONTROL OF THE ELECSYS ANTI-HBC IGM IMMUNOASSAY ON THE COBAS E 601 IMMUNOASSAY ANALYZER.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 S003 S004 S005 S006 S008 S009 S011 
S012 S013 S014 S015 S016 S017 S018 S019 S020 
S021 
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