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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.
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)
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