# K260048: Elecsys Anti-HAV IgM

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Apr 7, 2026 after 90 days
- Product code: LOL (Hepatitis A Test (Antibody And Igm Antibody))
- Device class: 2
- Regulation: 21 CFR 866.3310
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K063329 (2007). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K251995: Access anti-HAV IgM, Beckman Coulter, Inc. (2026). Cleared while this submission was under review Summary page 7.

## Indications for use
Immunoassay for the in vitro qualitative detection of IgM antibodies to hepatitis A virus (anti-HAV 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 signs and symptoms of hepatitis or persons who may be at risk for hepatitis A infection. The assay is intended for use as an aid in the laboratory diagnosis of an acute or recently acquired hepatitis A virus (HAV) infection. Assay results, in conjunction with other laboratory results and clinical information, may be used to provide presumptive evidence of infection with HAV. The electrochemiluminescence immunoassay “ECLIA” is intended for use on cobas e immunoassay analyzers.

Source page: https://510kreport.com/device/K260048
Methodology: https://510kreport.com/methodology