# K082050: Liaison Hav Igm Assay, Liaison Control Hav Igm

- Pathway: 510(k) (Traditional)
- Applicant: DiaSorin, Inc.
- Decided: Nov 3, 2008 after 108 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.
3 later devices descend from it; 1 cites 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)
- P890014: HA-Igmk and Eti-HA-Igmk, DiaSorin, Inc. (1990) Summary page 1.

## Most influential descendants
- K103529: Liaison XL Analyzer Model 10050 (2011), 2 descendants of its own
- K141116: Liaison XL Analyzer (2014), 1 descendant of its own
- K260770: LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX (2026), 0 descendants of its own

## Indications for use
The LIAISON® HAV IgM assay is an in vitro chemiluminescent immunoassay intended for the qualitative detection of IgM antibodies to hepatitis A virus (IgM anti-HAV) in human serum and sodium heparin plasma using the LIAISON® Analyzer. Assay results, in conjunction with other serological and clinical information, may be used for testing specimens from individuals who have signs and symptoms consistent with acute hepatitis as an aid in the laboratory diagnosis of acute or recent HAV infection. This assay is not intended for screening blood or solid or soft tissue donors. Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients. The user is responsible for establishing their own assay performance characteristics in these populations. The LIAISON® Control HAV IgM (negative and reactive) is intended for use as assayed quality control samples to monitor the performance of the LIAISON® HAV IgM assay.

Source page: https://510kreport.com/device/K082050
Methodology: https://510kreport.com/methodology