# K063319: Monolisa Anti-Hav Igm 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 P890014 (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)
- P890014: HA-Igmk and Eti-HA-Igmk, DiaSorin, Inc. (1990) Summary page 2.

## Most influential descendants
- K092353: Monolisa Anti-Hav Igm Eia (2009), 0 descendants of its own

## Indications for use
The MONOLISA Anti-HAV IgM EIA is an in vitro enzyme immunoassay kit intended for use in the qualitative detection of IgM antibodies to Hepatitis A virus (anti-HAV IgM) in human (adult and pediatric) serum or plasma (EDTA, Heparin, Citrate, ACD). This assay is indicated for testing specimens from individuals who have signs and symptoms consistent with acute Hepatitis. Assay results, in conjunction with other serological or clinical information, may be used for the laboratory diagnosis of individuals with acute or recent Hepatitis A. 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/K063319
Methodology: https://510kreport.com/methodology