# K982348: Ebna-1 Igm Elisa Test System

- Pathway: 510(k) (Traditional)
- Applicant: Columbia Bioscience, Inc.
- Decided: Nov 25, 1998 after 142 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. The FDA summary names its predicate without a number.
- (no number) EBV Serology: named in the summary without a submission number

## Indications for use
For the qualitative determination of IgM antibodies in human serum to Epstien Barr (recombinant) nuclear antigen (EBNA-1) antigen. The & EBNA-1 IgM assay should be used in conjunction with other Epstein-Barr serologies (VCA IgM, VCA IgG, EA-D IgG, EA-D M, EBNA-1 G and heterophile) as an aid in the diagnosis of infectious mononucleosis. The test can be performed either manually or in conjunction with the MAGO PLUS ™ Automated EIA Processor.

Source page: https://510kreport.com/device/K982348
Methodology: https://510kreport.com/methodology