# K150375: LIAISON VZV IgG, LIAISON Control VZV IgG

- Pathway: 510(k) (Special)
- Applicant: DiaSorin, Inc.
- Decided: Mar 11, 2015 after 26 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: 2 generations back to K981867 (1998). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061820: Diasorin Liaison VZV Igg, DiaSorin, Inc. (2007) Summary page 4.

## Most influential descendants
- K231214: LIAISON VZV IgG HT, LIAISON Control VZV IgG HT (2023), 0 descendants of its own

## Indications for use
The DiaSorin LIAISON® VZV IgG uses chemiluminescence immunoassay (CLIA) technology on the LIAISON® Analyzer family for the qualitative detection of specific IgG antibodies to varicella-zoster virus (VZV) in human serum. This assay can be used as an aid in the determination of previous infection of varicella-zoster virus. 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. The DiaSorin LIAISON® Control VZV IgG (negative and positive) is intended for use as assayed quality control samples to monitor the performance of the DiaSorin LIAISON® VZV IgG assay on the LIAISON® Analyzer family. The performance characteristics of the LIAISON® Control VZV IgG have not been established for any other assays or instrument platforms different from LIAISON® and LIAISON® XL.

Source page: https://510kreport.com/device/K150375
Methodology: https://510kreport.com/methodology