# K260046: Elecsys Anti-HBc II

- 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 P080023 (2009). 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)
- P080023: Architect Core Reagent Kit, Architect Core Calibrator and Architect Core Controls, Abbott Laboratories (2009) Summary page 5.

## Indications for use
Immunoassay for the in vitro qualitative determination of total antibodies to hepatitis B core antigen (anti-HBc) in human serum and plasma (lithium heparin, sodium citrate, potassium EDTA) from adult and pediatric (2 through 21 years of age) patients with the symptoms of hepatitis or who may be at risk for hepatitis B virus (HBV) infection. The detection of total anti-HBc is indicative of a laboratory diagnosis for HBV infection. Further HBV serological marker testing is required to define the specific disease state. 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 cobas e immunoassay analyzers.

Source page: https://510kreport.com/device/K260046
Methodology: https://510kreport.com/methodology