# K233605: ADVIA Centaur EBV-EBNA IgG

- Pathway: 510(k) (Traditional)
- Applicant: Biokit, S.A.
- Decided: Aug 7, 2024 after 272 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
Longest line of descent: 2 generations back to K946159 (1995). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040120: Diasorin Liaison Ebna Igg, Liaison Vca Igg, Liaison Vca Igm Assays, DiaSorin, Inc. (2005) Summary page 4.

## Indications for use
The ADVIA Centaur EBV-EBNA IgG (EBVnaG) assay is for in vitro diagnostic use in the qualitative detection of IgG antibodies to Epstein-Barr virus (EBV) nuclear antigen (EBNA) in human pediatric (2-21 years old) and adult serum and plasma (EDTA and lithium heparin) using the ADVIA Centaur XP system. When used in conjunction with other EBV markers, this assay is intended for use as an aid in the diagnosis of Epstein-Barr virus infection, such as infectious mononucleosis.

Source page: https://510kreport.com/device/K233605
Methodology: https://510kreport.com/methodology