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.
| Device | Elecsys Anti-HBe, PreciControl Anti-HBe |
| Generic Name | Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm) |
| Applicant | Roche Diagnostics |
| Date Received | 2019-03-01 |
| Decision Date | 2021-02-03 |
| PMA | P190005 |
| Supplement | S |
| Product Code | LOM |
| Advisory Committee | Microbiology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Roche Diagnostics 9115 Hague Road indianapolis, IN 46250 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P190005 | | Original Filing |
| S001 |
2021-04-02 |
Normal 180 Day Track |
NIH GUDID Devices