# K210272: LIAISON Anti-HAV

- Pathway: 510(k) (Special)
- Applicant: DiaSorin, Inc.
- Decided: Feb 9, 2021 after 8 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 K193532 (2020). 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)
- K193532: LIAISON Anti-HAV Assay, DiaSorin, Inc. (2020) Summary page 4.

## Most influential descendants
- K223403: LIAISON Anti-HAV; LIAISON XS (2022), 0 descendants of its own

## 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 heparin plasma samples using the LIAISON® Analyzer family. 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.

Source page: https://510kreport.com/device/K210272
Methodology: https://510kreport.com/methodology