# K061820: Diasorin Liaison VZV Igg

- Pathway: 510(k) (Traditional)
- Applicant: DiaSorin, Inc.
- Decided: Feb 26, 2007 after 243 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: 1 generation back to K981867 (1998). 1 ancestor in all.
2 later devices descend 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)
- K981867: IS-Vzu Igg Test System, Diamedix Corp. (1998) Summary page 1.

## Most influential descendants
- K150375: LIAISON VZV IgG, LIAISON Control VZV IgG (2015), 1 descendant of its own
- K231214: LIAISON VZV IgG HT, LIAISON Control VZV IgG HT (2023), 0 descendants of its own

## Indications for use
The LIAISON® VZV IgG Assay uses chemiluminescence immunoassay (CLIA) technology on the LIAISON® Analyzer for the qualitative detection of specific IgG antibodies to varicella-zoster virus in human serum. This assay can be used as an aid in the determination of previous infection of varicella-zoster virus.

Source page: https://510kreport.com/device/K061820
Methodology: https://510kreport.com/methodology