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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® HBEAG IMMUNOASSAY AND ELECSYS® PRECICONTROL HBEAG
Generic NameTest, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Regulation Number866.3172
ApplicantRoche Diagnostics Operations, Inc.
9115 Hague Rd.
Indianapolis, IN 46250
PMA NumberP130015
Date Received05/30/2013
Decision Date03/14/2014
Reclassified Date10/20/2025
Product Code LOM 
Docket Number 14M-0326
Notice Date 03/31/2014
Advisory Committee Microbiology
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE ELECSYS HBEAG IMMUNOASSAY AND ELECSYS PRECICONTROL HBEAG. THIS DEVICE IS INDICATED FOR:ELECSYS HBEAG IMMUNOASSAYTHE 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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
S012 S013 S014 S015 S016 S017 S018 S019 S020 S021 S022 
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