# K082049: Liaison Anti-Hav Assay, Liaison Control Anti-Hav

- Pathway: 510(k) (Traditional)
- Applicant: DiaSorin, Inc.
- Decided: Dec 5, 2008 after 140 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.
No later device cites it as a predicate yet.
0 of 2 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 1.

## Indications for use
The LIAISON® Anti-HAV assay is an in vitro chemiluminescent immunoassay intended for the qualitative detection of total antibodies to hepatitis A (anti-HAV) in human serum and sodium heparinized plasma samples using the automated LIAISON® Analyzer. The assay is indicated as an aid in the laboratory diagnosis of current or previous HAV infections in conjunction with other serological and clinical information and to determine the presence of an antibody response to HAV in vaccine recipients. 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 Anti-HAV (negative and positive) is intended for use as assayed quality control samples to monitor the performance of the LIAISON® Anti-HAV assay.

Source page: https://510kreport.com/device/K082049
Methodology: https://510kreport.com/methodology