# K980598: Ebna-1 Igm Elisa Test System

- Pathway: 510(k) (Traditional)
- Applicant: Clark Laboratories, Inc.
- Decided: May 1, 1998 after 73 days
- Product code: LLM (Test, Antigen, Nuclear, Epstein-Barr Virus)
- 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. The FDA summary names its predicate without a number.
- (no number) EBV serology: named in the summary without a submission number

## Indications for use
The Epstein Barr Nuclear Antigen 1 (EBNA-1) IgM kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative determination of IgM antibodies in human serum to EBNA-1 antigen. The Clark anti-EBNA-1 IgM assay may be used in conjunction with other Epstein-Barr serologies (VCA IgG, VCA IgM, EA-D IgG, EBNA-1 IgG and heterophile) as an aid in the diagnosis of infectious mononucleosis in adult populations.

Source page: https://510kreport.com/device/K980598
Methodology: https://510kreport.com/methodology