# K092355: Monolisa Anti-Hav Eia

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad Laboratories, Inc.
- Decided: Oct 29, 2009 after 86 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 P890019 (1990). 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)
- K063318: Monolisa Anti-Hav Eia, Bio-Rad Laboratories (2007) Summary page 1.

## Indications for use
The MONOLISATM Anti-HAV EIA is an in vitro enzyme immunoassay kit intended for use in the qualitative detection of total antibodies (IgG and IgM) to hepatitis A virus (anti-HAV) in human (adult and pediatric) serum or plasma (EDTA, Heparin, Citrate, ACD). This kit can be used as an aid in the diagnosis of acute or past hepatitis A virus (HAV) infection or as an aid in the identification of HAV-susceptible individuals for vaccination. However, any diagnosis should take into consideration the patient's clinical history and symptoms, as well as serological data. The MONOLISA TM Anti-HAV EIA is intended for manual use and with the EVOLIS TM Automated Microplate System in the detection of total antibodies to hepatitis A virus. Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients, and cord blood or neonatal specimens. Warning: This assay is not intended for screening blood or solid or soft tissue donors.

Source page: https://510kreport.com/device/K092355
Methodology: https://510kreport.com/methodology