# K231214: LIAISON VZV IgG HT, LIAISON Control VZV IgG HT

- Pathway: 510(k) (Traditional)
- Applicant: DiaSorin, Inc.
- Decided: Oct 27, 2023 after 182 days
- Product code: LFY (Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster)
- Device class: 2
- Regulation: 21 CFR 866.3900
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K981867 (1998). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150375: LIAISON VZV IgG, LIAISON Control VZV IgG, DiaSorin, Inc. (2015) Summary page 4.

## Indications for use
The LIAISON VZV IgG HT assay uses chemiluminescent immunoassay (CLIA) technology for the in vitro qualitative detection of specific IgG antibodies to varicella-zoster virus (VZV) in human serum (with gel and without gel-SST), dipotassium EDTA (K2- EDTA), lithium heparin and sodium heparin plasma samples. This assay is intended as an aid in the determination of previous infection of varicella-zoster virus. The test must be performed on the LIAISON XL Analyzer. The assay performance in detecting antibodies to VZV in individuals vaccinated with the FDA-licensed VZV vaccine is unknown. The user of this assay is responsible for establishing the performance characteristics with VZV vaccinated individuals.

Source page: https://510kreport.com/device/K231214
Methodology: https://510kreport.com/methodology