Elecsys Anti-HBe, PreciControl Anti-HBe

FDA Premarket Approval P190005

Pre-market Approval Supplement Details

The elecsys anti-hbe 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.

DeviceElecsys Anti-HBe, PreciControl Anti-HBe
Generic NameTest, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
ApplicantRoche Diagnostics
Date Received2019-03-01
Decision Date2021-02-03
PMAP190005
SupplementS
Product CodeLOM 
Advisory CommitteeMicrobiology
Expedited ReviewNo
Combination Product No
Applicant Address Roche Diagnostics 9115 Hague Road indianapolis, IN 46250

Supplemental Filings

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Supplement NumberDateSupplement Type
P190005Original Filing

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