# K063318: Monolisa Anti-Hav Eia

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad Laboratories
- Decided: May 3, 2007 after 182 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: 1 generation back to P890019 (1990). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P890019: AB -Havk, Diasorin (1990) Summary page 2.

## Most influential descendants
- K092355: Monolisa Anti-Hav Eia (2009), 0 descendants of its own

## Indications for use
The MONOLISA TM 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. 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/K063318
Methodology: https://510kreport.com/methodology