# K260049: Elecsys Anti-HBc IgM

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Apr 7, 2026 after 90 days
- Product code: SEI (Qualitative And Quantitative Hepatitis B Virus Antibody Assays)
- Device class: 2
- Regulation: 21 CFR 866.3173
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to P060035 (2007). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P060035: Architect Core-M Reagent Kit/Calibrators/Controls, Abbott Laboratories (2007) Summary page 5.

## Indications for use
Immunoassay for the in vitro qualitative determination of IgM antibodies to hepatitis B core antigen (anti-HBc IgM) in human serum and plasma (potassium EDTA, lithium heparin, sodium heparin, sodium citrate) from adult and pediatric (2 through 21 years of age) patients with symptoms of hepatitis or who may be at risk for hepatitis B (HBV) infection. The presence of anti-HBc IgM, in conjunction with other laboratory results and clinical information, is indicative of acute or recent hepatitis B virus (HBV) infection. The immunoassay’s performance has not been established for the monitoring of HBV disease or therapy. The electrochemiluminescence immunoassay “ECLIA” is intended for use on the cobas e immunoassay analyzers.

Source page: https://510kreport.com/device/K260049
Methodology: https://510kreport.com/methodology