# K981120: Zeus Scientific Inc., Anti-Ebv EA Igg Elisa

- Pathway: 510(k) (Traditional)
- Applicant: Zeus Scientific, Inc.
- Decided: Aug 21, 1998 after 147 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
Epstein-Barr Virus (EBV) causes infectious mononucleosis; a self-limiting lymphoproliferative disease. EBV is a ubiquitous human virus. By adulthood, virtually everyone has been infected and has developed immunity to the virus. [n underdeveloped countries, seroconversion to the virus takes place in early childhood and is usually asymptomatic. Following seroconversion, whether symptomatic or not, EBV establishes a chronic latent infection in B lymphocytes which lasts probably for life. Reactivation of the latent viral carrier state, as evidenced by increased rates of virus shedding, is enhanced by immunosuppression, pregnancy, malnutrition or disease. Antibody titers to specific EBV antigens correlate with different stages of infectious mononucleosis. Antibodies to EA may appear transiently for up to three months or longer during the acute phase of IM in 85% of patients. Antibodies to EA together with antibodies to EBNA and high titers of IgG to VCA may be associated with reactivation of the latent viral carrier state. This test system is designed to detect IgG antibodies to EBV EA in human serum specimens. This test system is intended to be used as an aid in the diagnosis of infectious mononucleosis. The performance characteristics have not been established to aid in the diagnosis of acute IM.

Source page: https://510kreport.com/device/K981120
Methodology: https://510kreport.com/methodology