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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 Anti-HBs II, PreciControl Anti-HBs, Anti-HBs CalCheck
Generic Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantRoche Diagnostics
9115 hague road
po box 50416
indianapolis, IN 46250
PMA NumberP190034
Date Received12/30/2019
Decision Date02/23/2021
Product Code LOM 
Docket Number 21M-0228
Notice Date 02/25/2021
Advisory Committee Microbiology
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the Elecsys Anti-HBs II, PreciControl Anti-HBs, Anti-HBs CalCheck.Elecsys Anti-HBs II Immunoassay for the in vitro quantitative determination of total antibodies to the hepatitis B surface antigen (HBsAg) in human adult, pregnant women, and pediatric (ages 2 to 21 years) serum and plasma (K2-EDTA and K3-EDTA). Assay results may be used as an aid in the determination of susceptibilty to hepatitis B virus (HBV) infection for individuals prior to or following HBV vaccination; or where vaccination status is unknown.Assay results may be used with other HBV serological markers for the laboratory diagnosis of HBV disease associated with HBV infection. A reactive assay result will allow a differential diagnosis in individuals displaying signs and symptons of hepatitis in whom etiology is unknown. The detection of anti-HBs is indicative of laboratory diagnosis of seroconversion from hepatitis B virus (HBV) infection or from vaccination.The electrochemiluminescence immunoassay ECLIA is intended for use on the cobas e 601 immunoassay analyzer.PreciControl Anti-HBsPreciControl Anti-HBs is used for quality control of the Elecsys Anti-HBs immunoassay on the Elecsys and cobas e immunoassay analyzers and of the Elecsys Anti-HBs II immunoassay on the cobas e 601 immunoassay analyzer. The performance of PreciControl Anti-HBs has not been established with any other anti-HBs assay.Anti-HBs CalCheckAnti-HBs CalCheck is an assayed control material for use in the verification of the calibration established by the Elecsys Anti-HBs immunoassay on the cobas e immunoassay analyzers and by the Elecsys Anti-HBs II immunoassay on the cobas e 601 immunoassay analyzer.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 
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