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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)
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 Microbiology
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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
Supplements: S001 S002 S003 S004 S005 S006 S008 S009 S011 
S012 S013