# K972295: Seraquest VZV Igg

- Pathway: 510(k) (Traditional)
- Applicant: Quest Intl., Inc.
- Decided: Nov 5, 1997 after 139 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
1. For in vitro diagnostic use only. 2. FFor the qualitative and semi-quantitative detection of IgG antibodies to varicella zoster virus (VZV) in human serum by enzyme immunoassay. 3. Individual specimens may be used for the determination of immune status. 4. Paired (acute / convalescent) sera, may be used to demonstrate seroconversion or significant rises in antibody level, as an aid in the diagnosis of primary infection, or reactivation of VZV. 5. For manual use, or for use with the HyPrep System Plus semi-automated fluid handler.

Source page: https://510kreport.com/device/K972295
Methodology: https://510kreport.com/methodology