# K900688: Varicella Zoster Igg Clin-Elisa Test Kit

- Pathway: 510(k) (Traditional)
- Applicant: Clinical Sciences, Inc.
- Decided: May 15, 1990 after 91 days
- Product code: LFY (Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster)
- Device class: 2
- Regulation: 21 CFR 866.3900
- Recalls of this device: 1 (0 Class I)
- 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. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Sep 10, 2003 · Not classified · Z-0572-05: Varicella Zoster ELISA kit assay was producing invalid runs on the ETI-Max 3000 automated microtiter plate instrument and/or false negative results.

Source page: https://510kreport.com/device/K900688
Methodology: https://510kreport.com/methodology