# K040120: Diasorin Liaison Ebna Igg, Liaison Vca Igg, Liaison Vca Igm Assays

- Pathway: 510(k) (Traditional)
- Applicant: DiaSorin, Inc.
- Decided: Apr 29, 2005 after 465 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: 1 generation back to K946159 (1995). 3 ancestors in all.
4 later devices descend from it; 4 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K946159: Incstar Epstein-Barr Viral Capsid Antigen (Vca) Igg Elisa Kit, Incstar Corp. (1995) Summary page 13.
- K946157: Incstar Epstein-Barr Viral Capsid Antigen (Vca) LGM Elisa Kit, Incstar Corp. (1995) Summary page 7.
- K946158: Incstar Epstein-Barr Nuclear Antigen (Ebna_ Igg Elisa Kit, Incstar Corp. (1995) Summary page 1.

## Most influential descendants
- K233606: ADVIA Centaur EBV-VCA IgM (2024), 0 descendants of its own
- K233605: ADVIA Centaur EBV-EBNA IgG (2024), 0 descendants of its own
- K162961: LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and LIAISON® EBNA IgG Serum Control Set (2017), 0 descendants of its own
- K161522: LIAISON EBV IgM Serum Control Set (2016), 0 descendants of its own

## Indications for use
The LIAISON® VCA IgG assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® Analyzer for the qualitative determination of IgG antibodies to Epstein-Barr virus (EBV) viral capsid antigen (VCA) p-18 synthetic peptide in human serum. When performed in conjunction with other EBV markers, 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). The LIAISON® EBV IgM assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® Analyzer for the qualitative determination of IgM antibodies to Epstein-Barr virus (EBV) viral capsid antigen (VCA) p-18 synthetic peptide in human serum. When performed in conjunction with other EBV markers, 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). The LIAISON® EBNA IgG assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® Analyzer for the qualitative determination of IgG antibodies to Epstein-Barr virus (EBV) nuclear antigen synthetic peptide (EBNA-1) in human serum. When performed in conjunction with other EBV markers, 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/K040120
Methodology: https://510kreport.com/methodology