# K983804: The Aptus (Automated) Application of the Ebv-EA Igg Elisa Test System. an Enzyme Linked Immunosorbent Assay (Elisa) for

- Pathway: 510(k) (Traditional)
- Applicant: Zeus Scientific, Inc.
- Decided: Dec 8, 1998 after 41 days
- Product code: LSE (Epstein-Barr Virus, Other)
- Device class: 1
- Regulation: 21 CFR 866.3235
- 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
This lust system is an anzyme linked immunosarbent assay which provided a means for the manual or automatod (Aplue), qualitatve detaction ot IgG anfibodies to EBV-EA in human sorum.. This teat system i infendad to be tisad as an ad in the diagnosis of infectious moenonuoloosie when ue ad with other EBV sarolagles. The performaiice characteristics have not been established to aid in the diagnasis ot acuta IM.

Source page: https://510kreport.com/device/K983804
Methodology: https://510kreport.com/methodology