# K060204: Liaison EA Igg

- Pathway: 510(k) (Traditional)
- Applicant: DiaSorin, Inc.
- Decided: Oct 18, 2006 after 265 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
Longest line of descent: 1 generation back to K992191 (1999). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992191: Eti-EA-G Assay, DiaSorin, Inc. (1999) Summary page 1.

## Most influential descendants
- K162959: LIAISON® EA IgG and LIAISON® EA IgG Serum Control Set (2017), 0 descendants of its own

## Indications for use
The LIAISON® EA IgG assay and LIAISON® EA IgG Controls use chemiluniescent immunoassay (CLIA) technology on the LIAISON Analyzer for the qualitative determination of IgG antibodies to Epstein-Barr virus early antigen-diffuse [EA(D)] in human serum. This assay can be used as an aid in the clinical laboratory diagnosis of Epstein-Barr viral Syndrome in patients with signs and symptoms of EBV infection such as infectious mononucleosis (IM).

Source page: https://510kreport.com/device/K060204
Methodology: https://510kreport.com/methodology