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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-HBe, PreciControl Anti-HBe
Generic Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantRoche Diagnostics
9115 hague road
indianapolis, IN 46250
PMA NumberP190005
Date Received03/01/2019
Decision Date02/03/2021
Product Code LOM 
Docket Number 21M-0178
Notice Date 02/09/2021
Advisory Committee Microbiology
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the Elecsys Anti-HBe The device is an immunoassay for the in vitro qualitative detection of total antibodies to hepatitis B e antigen (anti-HBe) in human adult serum or plasma (potassium EDTA, lithium heparin, sodium citrate, sodium heparin) from individuals with symptoms of hepatitis or at risk for hepatitis B virus (HBV) infection. Assay results, in conjunction with other laboratory results and clinical information may be used as an aid in the diagnosis of hepatitis B virus (HBV) infection in patients with symptoms of hepatitis or who may be at risk for HBV infection. A reactive test is presumptive laboratory evidence of HBV seroconversion. Further HBV serological marker testing is required to define the specific disease state. The PreciControl Anti-HBe is used for quality control of the Elecsys Anti-HBe immunoassay on the cobas e 602 immunoassay analyzer. The performance of PreciControl Anti-HBe has not been established with any other anti-HBe assay.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 
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