# K092353: Monolisa Anti-Hav Igm 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to P890014 (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)
- K063319: Monolisa Anti-Hav Igm Eia, Bio-Rad Laboratories (2007) Summary page 1.

## Recalls of this device
- Jul 19, 2010 · Not classified · Z-2201-2011: The EVOLIS Assay Protocol Files Software is configured in such a way that may result in a miscalculation of quantitative test results and/or an error in reporting positive/negative sample values.

## Indications for use
The MONOLISA TM 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. The MONOLISA TM Anti-HAV IgM EIA is intended for manual use and with the Evolis TM Automated Microplate System in the detection of IgM 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/K092353
Methodology: https://510kreport.com/methodology