# K193532: LIAISON Anti-HAV Assay

- Pathway: 510(k) (Traditional)
- Applicant: DiaSorin, Inc.
- Decided: Mar 2, 2020 after 73 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
No predicates in its family tree.
2 later devices descend 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)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K210272: LIAISON Anti-HAV (2021), 1 descendant of its own
- 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. The assay is not intended for screening blood or solid or soft tissue donors.

Source page: https://510kreport.com/device/K193532
Methodology: https://510kreport.com/methodology