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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
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 NumberP110031
Date Received07/29/2011
Decision Date01/03/2012
Product Code
LOM[ Registered Establishments with LOM ]
Docket Number 12M-0024
Notice Date 01/10/2012
Advisory Committee Microbiology
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 411 IMMUNOASSAY ANALYZER. THE DEVICE IS INDICATED FOR: ELECSYS ANTI-HBC IGM IMMUNOASSAY, 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 (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 IMMUNOASSAYS PERFORMANCE HAS NOT BEEN ESTABLISHED FOR THE MONITORING OF HBV DISEASE OR THERAPY.THE ELECTROCHEMILUMINESCENCE IMMUNOASSAY ECLIA IS INTENDED FOR USE ON THE COBAS E 411 IMMUOASSAY ANALYZER.ELECSYS PRECICONTROL ANTI-HBC IGM - THE ELECSYS PRECICONTROL ANTI-HBC IGM IS USED FOR THE QUALITY CONTROL OF THE ELECSYS ANTI-HBC IGM IMMUNOASSAY ON THE COBAS E 411 IMMUNOASSAY ANALYZER.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 S003 S004 S005 S006 S008 S010 S011 
S012 S013 S014 S015 S016 S017 
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