# K981867: IS-Vzu Igg Test System

- Pathway: 510(k) (Traditional)
- Applicant: Diamedix Corp.
- Decided: Sep 28, 1998 after 123 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
No predicates in its family tree.
3 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)
- None. The FDA summary names its predicate without a number.
- (no number) Diamedix VZVMicroassay: named in the summary without a submission number

## Most influential descendants
- K061820: Diasorin Liaison VZV Igg (2007), 2 descendants of its own
- 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
For the qualitative and semi-quantitative detection of IgG antibodies to Varicella-Zoster Virus (VZV) in human serum by indirect immunoassay to determine a prior exposure to VZV and, when evaluating paired sera, to aid in the determination of acute or convalescent stage of VZV infection. These reagents can be used either manually or in conjunction with the MAGO® Plus Automated EIA Processor.

Source page: https://510kreport.com/device/K981867
Methodology: https://510kreport.com/methodology