# K983801: The Aptus (Automated) Application of the Ebv-Vca Igm Elisa Test System.  an Enzyme Linked Immunosorbent Assay (Elisa) FO

- Pathway: 510(k) (Traditional)
- Applicant: Zeus Scientific, Inc.
- Decided: Dec 10, 1998 after 43 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
The test system is an enzyme-linked immunosorbent assay designed for the manual or automated (Aptus) qualitative detection of IgM class antibodies to EBV-VCA in human serum. The test system is intended to be used for the diagnosis of EBV-associated infectious mononucleosis (IM) when used in conjunction with other EBV serologies.

Source page: https://510kreport.com/device/K983801
Methodology: https://510kreport.com/methodology