# K190428: Elecsys Anti-HAV II

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Aug 13, 2019 after 172 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 P780012 (1979). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100903: Anti-Hav, Roche Professional Diagnostics (2010) Summary page 5.

## Most influential descendants
- K242492: Multichem ID-G (09339892190); Multichem ID-G (SR102G); Multichem ID-G (SR102MG); Multichem ID-GNeg (09339906190); Multichem ID-GNeg (SR102N); Multichem ID-GNeg (SR102MN) (2025), 0 descendants of its own
- K243846: Access anti-HAV (2025), 0 descendants of its own

## Indications for use
Immunoassay for the in vitro qualitative detection of total antibodies (IgG and IgM) to hepatitis A virus (HAV) in human pediatric (ages 2 through 21 years) and adult serum and plasma (Li-heparin, potassium EDTA, Na-citrate, Na-heparin). The assay, in conjunction with other serological and clinical information, is indicated as an aid in the clinical laboratory diagnosis of acute or past hepatitis A virus infection in persons with signs or symptoms of hepatitis and in persons at increased risk for hepatitis A infection, or as an aid to identify HAV susceptible individuals and to determine the presence of an antibody response to HAV in vaccine recipients. The electrochemiluminescence immunoassay “ECLIA” is intended for use on the cobas e immunoassay analyzers. Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients. This assay has not been FDA cleared or approved for the screening of blood or plasma donors.

Source page: https://510kreport.com/device/K190428
Methodology: https://510kreport.com/methodology