# K984126: The Aptus (Automated) Application of the Ebv-Vca Igg Elisa Test System. an Enzyme Linked Immunosorbent Assay (Elisa) for

- Pathway: 510(k) (Traditional)
- Applicant: Zeus Scientific, Inc.
- Decided: Jan 11, 1999 after 54 days
- Product code: MCD (Antigen, Ebv, Capsid)
- 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 test system is designed for the manual or automated, qualitative detection of IgG antibodies to EBV-VCA in human serum specimens. When used with other EBV serologies such as Heterophile, EBNA IgG an VCA IgM, this test system may aid in the diagnosis and provide information on infectious mononucleosis that may be of vaiue in patient management and treatment. The test is for in vitro diagnostic use.

Source page: https://510kreport.com/device/K984126
Methodology: https://510kreport.com/methodology