| K-number | K260049 |
| Device name | Elecsys Anti-HBc IgM |
| Applicant | Roche Diagnostics |
| Product code | SEI |
| Device class | Class II |
| Decision date | Apr 7, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 866.3173 |
Elecsys Anti-HBc IgM is an electrochemiluminescence immunoassay that qualitatively detects IgM antibodies to hepatitis B core antigen in human serum and plasma. It is used to aid in the diagnosis of acute or recent hepatitis B virus infection in adult and pediatric patients (ages 2-21 years) with symptoms or risk factors for HBV, and is intended for use on cobas e immunoassay analyzers.
The Elecsys Anti-HBc IgM uses a μ-capture test principle with electrochemiluminescence detection on the cobas e platform, compared to the Abbott ARCHITECT CORE-M predicate which uses a two-step chemiluminescent microparticle immunoassay on the ARCHITECT i System. Both measure the same analyte (anti-HBc IgM) and accept similar sample types, though Elecsys accepts an additional sample matrix (sodium citrate) and uses different calibrators and controls.
Not stated in this summary.
The Elecsys Anti-HBc IgM is substantially equivalent because it measures the same analyte with the same intended use as the predicate device for acute or recent HBV infection diagnosis in adult and pediatric populations. Performance data from 119 pediatric serum samples showed 100% negative percent agreement (95% CI: 96.9-100%), and a spiking study demonstrated equivalent assay performance between pediatric and adult samples with ±12% percent difference.
View the full FDA submission: accessdata.fda.gov