510(k) · Cleared
ClearedDiasorin Liaison Ebna Igg, Liaison Vca Igg, Liaison Vca Igm Assays
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DiaSorin, Inc. · LLM Test, Antigen, Nuclear, Epstein-Barr Virus
Cleared on Apr 29, 2005 as substantially equivalent to K946159 (Incstar Corp., 1995) and 2 other predicates after a 465-day review. Its family tree reaches back 1 generation to 1995. 4 later devices descend from it.
- Decided
- Apr 29, 2005
- Review
- 465 days
- Class
- Class I
- Product code
- LLM
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K946159 (1995). 3 ancestors in all. 4 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK946159 Incstar Epstein-Barr Viral Capsid Antigen (Vca) Igg Elisa KitIncstar Corp. · 1995
- This deviceK040120 Diasorin Liaison Ebna Igg, Liaison Vca Igg, Liaison Vca Igm AssaysDiaSorin, Inc. · 2005
- Descendant · cites it directly · 0 of its ownK233606 ADVIA Centaur EBV-VCA IgMBiokit, S.A. · 2024
- Descendant · cites it directly · 0 of its ownK233605 ADVIA Centaur EBV-EBNA IgGBiokit, S.A. · 2024
- Descendant · cites it directly · 0 of its ownK162961 LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON®…DiaSorin, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK161522 LIAISON EBV IgM Serum Control SetDiaSorin, Inc. · 2016
Most influential descendants
Showing 4 of 4 · See all- K233606ADVIA Centaur EBV-VCA IgMBiokit, S.A. · 2024 · cites it directly0descendants
- K233605ADVIA Centaur EBV-EBNA IgGBiokit, S.A. · 2024 · cites it directly0descendants
- K162961LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and LIAISON®…DiaSorin, Inc. · 2017 · cites it directly0descendants
- K161522LIAISON EBV IgM Serum Control SetDiaSorin, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K946159 | Incstar Epstein-Barr Viral Capsid Antigen (Vca) Igg Elisa Kit | Incstar Corp. | 1995 | — |
| 0 (this device) | K040120 | Diasorin Liaison Ebna Igg, Liaison Vca Igg, Liaison Vca Igm Assays | DiaSorin, Inc. | 2005 | — |
| +1 | K233606 | ADVIA Centaur EBV-VCA IgM | Biokit, S.A. | 2024 | — |
| +1 | K233605 | ADVIA Centaur EBV-EBNA IgG | Biokit, S.A. | 2024 | — |
| +1 | K162961 | LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and… | DiaSorin, Inc. | 2017 | — |
| +1 | K161522 | LIAISON EBV IgM Serum Control Set | DiaSorin, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2024 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LLM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LLM device
- #1 K233605 ADVIA Centaur EBV-EBNA IgGscore 8.1 · 2 generations · no Class I recall
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K946159 | Incstar Epstein-Barr Viral Capsid Antigen (Vca) Igg Elisa KitSummary page 13…EPSTEIN-BARR VIRUS, OTHER Product Code: LSE PREDICATE DEVICE: DiaSorin ETI-VCA-G Kit (K946159) DEVICE DESCRIPTION: INTENDED USE: The DiaSorin LIAISON® VCA IgG kit uses chemiluminescence immunoassay (CLIA) technology on th… | 1995 |
| * | K946157 | Incstar Epstein-Barr Viral Capsid Antigen (Vca) LGM Elisa KitSummary page 7…EPSTEIN-BARR VIRUS, OTHER Product Code: LSE PREDICATE DEVICES: DiaSorin ETI-EBV-M reverse Kit (K946157) DEVICE DESCRIPTION: INTENDED USE: The LIAISON® EBV IgM assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISO… | 1995 |
| * | K946158 | Incstar Epstein-Barr Nuclear Antigen (Ebna_ Igg Elisa KitSummary page 1…NTIGEN, NUCLEAR, EPSTEIN-BARR VIRUS Product Code: LLM PREDICATE DEVICE: DiaSorin ETI-EBNA-G Kit (K946158) DEVICE DESCRIPTION: INTENDED USE: The DiaSorin LIAISON® EBNA IgG kit uses chemiluminescence immunoassay (CLIA) technology on… | 1995 |
What descends from it? (4)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K233606 (Biokit, S.A., 2024) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LLM devicesLLM Test, Antigen, Nuclear, Epstein-Barr Virus: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LLM
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · LLM
Too few LLM 510(k)s in any year since 2007 to give a median.
Recalls per year · LLM
1in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLM
No MAUDE report names LLM since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 1 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (220 words)
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).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040120 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040120: Diasorin Liaison Ebna Igg, Liaison Vca Igg, Liaison Vca Igm Assays.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040120
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026