510(k) · Cleared
ClearedLIAISON EBV IgM Serum Control Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DiaSorin, Inc. · JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Cleared on Jun 30, 2016 as substantially equivalent to K040120 (DiaSorin, Inc., 2005) and 1 other predicate after a 28-day review. Its family tree reaches back 3 generations to 1992.
- Decided
- Jun 30, 2016
- Review
- 28 days
- Class
- Class I
- Product code
- JJX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K915892 (1992). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK915892 CMV Igg Elisa TestGull Laboratories, Inc. · 1992
- 2 generations backK955361 Incstar Cytomegalovirus Igg Elisa AssayIncstar Corp. · 1996
- 1 generation backK040290 Diasorin Liaison CMV Igm/IggDiasorin S.P.A · 2005
- This deviceK161522 LIAISON EBV IgM Serum Control SetDiaSorin, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K915892 | CMV Igg Elisa Test | Gull Laboratories, Inc. | 1992 | — |
| −2 | K955361 | Incstar Cytomegalovirus Igg Elisa Assay | Incstar Corp. | 1996 | — |
| −1 | K040290 | Diasorin Liaison CMV Igm/Igg | Diasorin S.P.A | 2005 | — |
| 0 (this device) | K161522 | LIAISON EBV IgM Serum Control Set | DiaSorin, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 3 | 0 |
| 2000 | 1 | 0 |
| 2005 | 1 | 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 JJX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K040120 | Diasorin Liaison Ebna Igg, Liaison Vca Igg, Liaison Vca Igm AssaysSummary page 4…Class I, reserved; Microbiology (83) Product Code: JJX PREDICATE DEVICE: LIAISON® Control EBV IgM (K040120) DEVICE DESCRIPTION: The LIAISON® EBV IgM Serum Control Set (negative and positive) consists of liquid ready-to-use controls in… | 2005 |
| * | K040290 | Diasorin Liaison CMV Igm/IggSummary page 5…® ® Characteristic LIAISON Control EBV IgM LIAISON EBV IgM Serum Control K040290, cleared 06/01/2005 Set ® The LIAIS… | 2005 |
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 24 years and passes through 4 companies; a new generation was cleared every 8.9 years on median.
- 1 of the 8 ancestors has a recall of any class.
- 3 other devices also cite its predicate K040120.
How does its category compare?
All JJX devicesJJX Single (Specified) Analyte Controls (Assayed And Unassayed): FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · JJX
2in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JJX
31in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JJX
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJX
22in 2025
MAUDE reports naming product code JJX, 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 | 6 | 53 | 3 | 2 |
| 2008 | 8 | 52 | 3 | 0 |
| 2009 | 17 | 80 | 0 | 1 |
| 2010 | 24 | 80 | 3 | 6 |
| 2011 | 19 | 62 | 2 | 62 |
| 2012 | 15 | 40 | 0 | 32 |
| 2013 | 19 | 37 | 0 | 51 |
| 2014 | 22 | 30 | 1 | 48 |
| 2015 | 11 | 65 | 1 | 67 |
| 2016 | 6 | 31 | 2 | 37 |
| 2017 | 2 | — | 0 | 19 |
| 2018 | 0 | — | 2 | 35 |
| 2019 | 0 | — | 0 | 82 |
| 2020 | 0 | — | 0 | 77 |
| 2021 | 0 | — | 1 | 43 |
| 2022 | 0 | — | 0 | 24 |
| 2023 | 0 | — | 0 | 22 |
| 2024 | 0 | — | 0 | 30 |
| 2025 | 0 | — | 0 | 22 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The LIAISON® EBV IgM Serum Control Set (negative and positive) is intended for use as assayed quality control samples to monitor the performance of the LIAISON® EBV IgM assay on the LIAISON® Analyzer family.
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/K161522 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161522: LIAISON EBV IgM 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/K161522
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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