510(k) · Cleared
ClearedLIAISON® EA IgG and LIAISON® EA IgG Serum Control Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DiaSorin, Inc. · LSE Epstein-Barr Virus, Other
Cleared on Jan 4, 2017 as substantially equivalent to K060204 (DiaSorin, Inc., 2006) after a 72-day review. Its family tree reaches back 2 generations to 1999.
- Decided
- Jan 4, 2017
- Review
- 72 days
- Class
- Class I
- Product code
- LSE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K992191 (1999). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 LSE? 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 LSE device
- #1 K233606 ADVIA Centaur EBV-VCA IgMscore 8.1 · 2 generations · no Class I recall
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K060204 | Liaison EA IggSummary page 4…3235; Class I, Microbiology (83) Product Code: LSE, JJX PREDICATE DEVICE: DiaSorin LIAISON® EA IgG (K060204) DEVICE DESCRIPTION: The LIAISON® EA IgG is an indirect chemiluminescence immunassay (CLIA) technology on the LIAISON Analyzer f… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 18 years and passes through 1 company; a new generation was cleared every 10.2 years on median.
- 1 of the 2 ancestors has a recall of any class.
How does its category compare?
All LSE devicesLSE Epstein-Barr Virus, Other: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · LSE
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · LSE
Too few LSE 510(k)s in any year since 2007 to give a median.
Recalls per year · LSE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LSE
1in 2014
MAUDE reports naming product code LSE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 2 | 0 |
| 2008 | 1 | — | 1 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 1 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 2 | — | 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 | — | 1 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The LIAISON® EA IgG assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® Analyzer family* for the qualitative determination of specific IgG antibodies to Epstein-Barr virus (EBV) early antigen-diffuse [EA(D)] in human serum. This assay uses a 47-kDa recombinant antigen expressed in E. coli DH-1 cells. When performed in conjunction with other EBV markers, this assay can be used as an aid in the clinical laboratory diagnosis of…
Read the full statement (147 words)
The LIAISON® EA IgG assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® Analyzer family* for the qualitative determination of specific IgG antibodies to Epstein-Barr virus (EBV) early antigen-diffuse [EA(D)] in human serum. This assay uses a 47-kDa recombinant antigen expressed in E. coli DH-1 cells. 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.
The DiaSorin LIAISON® EA IgG Serum Control Set is intended for use as assayed quality control samples to monitor the performance of the LIAISON® EA IgG assay on the LIAISON® Analyzer family*. The performance characteristics of the LIAISON® EA IgG controls have not been established for any other assay or instrument platforms different from the LIAISON® and LIAISON® XL.
*(LIAISON® and LIAISON® XL)
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K162959 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162959: LIAISON® EA IgG and LIAISON® EA IgG Serum Control Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162959
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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