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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 HBsAg II/Elecsys HBsAg Confirmatory Test/ PreciControl HBsAg II
Generic NameTest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantROCHE DIAGNOSTICS, INC.
9115 HAGUE ROAD
INDIANAPOLIS, IN 46038
PMA NumberP160019
Date Received07/01/2016
Decision Date12/23/2016
Product Code LOM 
Docket Number 16M-4530
Notice Date 01/18/2017
Advisory Committee Microbiology
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the Elecsys Hbsag II, Elecsys HBsAg Confirmatory Test, and PreciControl HBsAg II. This device is indicated for:Elecsys HBsAg II Immunoassay for the in vitro qualitative detection of hepatitis B surface antigen (HBsAg) in human adult and pediatric (2 to 21 years of age) serum and plasma (sodium heparin, lithium heparin, K2 EDTA, sodium citrate). Assay results, in conjunction with other serological and clinical information, may be used for the laboratory diagnosis of individuals at risk for infection with HBV or with signs and symptoms of hepatitis. In addition, this assay may be used to screen for hepatitis B infection in pregnant women to identify neonates at high risk of acquiring HBV during the perinatal period.The electrochemiluminescence immunoassay “ECLIA” is intended for use on the cobas e 601 immunoassay analyzer.Elecsys HBsAg Confirmatory TestFor Elecsys HBsAg Confirmatory Test used with Elecsys HBsAg immunoassay:Immunoassay for in vitro qualitative confirmation of the presence of hepatitis B surface antigen in human serum and plasma (sodium heparin, K3 EDTA, sodium citrate) samples repeatedly reactive when tested with the Elecsys HBsAg immunoassay. This assay is intended for use on the Elecsys and cobas e immunoassay analyzers.For Elecsys HBsAg Confirmatory Test used with Elecsys HBsAg II:Immunoassay for in vitro qualitative confirmation of the presence of hepatitis B surface antigen in human serum and plasma (sodium heparin, lithium heparin, K2 EDTA, sodium citrate) samples repeatedly reactive when tested with Elecsys HBsAg II. This assay is intended for use on the cobas e 601 immunoassay analyzer.PreciControl HBsAg IIPreciControl HBsAg II is used for quality control of the Elecsys HBsAg II immunoassay on the cobas e 601 immunoassay analyzer. The performance of PreciControl HBsAg II has not been established with any other HBsAg assay.
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 
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