# K070317: Zeus Scientific, Inc VZV Igm Elisa Test System

- Pathway: 510(k) (Traditional)
- Applicant: Zeus Scientific, Inc.
- Decided: Jul 5, 2007 after 153 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.
No later device cites it as a predicate yet.
0 of 1 device 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) Captia VZV IgM ELISA Test Kit: named in the summary without a submission number

## Indications for use
The Zeus Scientific Varicella Zoster Virus (VZV) IgM ELISA Test System is intended for the qualitative detection of IgM class antibodies to Varicella Zoster Virus in human serum as an aid in the diagnosis of primary infection or reactivation. 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 assay performance in detecting antibodies to VZV in cord blood and neonates has not been established.

Source page: https://510kreport.com/device/K070317
Methodology: https://510kreport.com/methodology