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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 NumberP130015
Date Received06/03/2013
Decision Date03/14/2014
Product Code
LOM[ Registered Establishments with LOM ]
Docket Number 14M-0326
Notice Date 03/31/2014
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 hbeag immunoassay and elecsys precicontrol hbeag. This device is indicated for: elecsys hbeag immunoassay the elecsys hbeag immunoassay is intended for the in vitro qualitative determination of hepatitis b e antigen (hbeag) in human serum or plasma (k2-edta, lithium or sodium heparin, and sodium citrate) in adult patients with symptoms of hepatitis or at risk for hepatitis b virus (hbv) infection. The assay results, in conjunction with other serological and clinical information, may be used for the laboratory diagnosis of individuals with acute or chronic hepatitis b or recovery from hepatitis b infection. The electrochemilumin-escence immunoassay eclia is intended for use on the modular analytics e170 analyzer. Elecsys precicontrol hbeag elecsys precicontrol hbeag is used for quality control of the elecsys hbeag immunoassay on the modular analytics e170 analyzer.
Approval Order Approval Order
Supplements: S001 S002 S003