510(k) · Cleared
ClearedDiasorin Liaison CMV Igm/Igg
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diasorin S.P.A · LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
Cleared on Jun 1, 2005 as substantially equivalent to K955361 (Incstar Corp., 1996) and 1 other predicate after a 481-day review. Its family tree reaches back 2 generations to 1992. 3 later devices descend from it.
- Decided
- Jun 1, 2005
- Review
- 481 days
- Class
- Class II
- Product code
- LFZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K915892 (1992). 3 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK915892 CMV Igg Elisa TestGull Laboratories, Inc. · 1992
- 1 generation backK955361 Incstar Cytomegalovirus Igg Elisa AssayIncstar Corp. · 1996
- This deviceK040290 Diasorin Liaison CMV Igm/IggDiasorin S.P.A · 2005
- Descendant · cites it directly · 0 of its ownK162969 LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control SetDiaSorin, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK161526 LIAISON CMV IgM Serum Control SetDiaSorin, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK161522 LIAISON EBV IgM Serum Control SetDiaSorin, Inc. · 2016
Most influential descendants
Showing 3 of 3 · See all- K162969LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control SetDiaSorin, Inc. · 2017 · cites it directly0descendants
- K161526LIAISON CMV IgM Serum Control SetDiaSorin, Inc. · 2016 · 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 |
|---|---|---|---|---|---|
| −2 | K915892 | CMV Igg Elisa Test | Gull Laboratories, Inc. | 1992 | — |
| −1 | K955361 | Incstar Cytomegalovirus Igg Elisa Assay | Incstar Corp. | 1996 | — |
| 0 (this device) | K040290 | Diasorin Liaison CMV Igm/Igg | Diasorin S.P.A | 2005 | — |
| +1 | K162969 | LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control Set | DiaSorin, Inc. | 2017 | — |
| +1 | K161526 | LIAISON CMV IgM Serum Control Set | DiaSorin, Inc. | 2016 | — |
| +1 | K161522 | LIAISON EBV IgM Serum Control Set | DiaSorin, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 0 |
| 2017 | 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 LFZ? 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 LFZ device
- #1 K220911 Elecsys CMV IgGscore 4.8 · 3 generations · no Class I recall
- #2 Held for the reportin 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 |
|---|---|---|---|
| * | K955361 | Incstar Cytomegalovirus Igg Elisa AssaySummary page 1…CYTOM EGALO VIRUS Product Code: LFZ PREDICATE DEVICE: DiaSorin CMV IgG ELISA Kit (K955361) DEVICE DESCRIPTION: INTENDED USE: The LIAISON® CMV lgG assay uses chemiluminescent immunoassay (CLIA) technology on the LIAIS… | 1996 |
| * | K001767 | Diamedix IS-CMV Igm Capture Test SystemSummary page 5…CYTOMEGALOVIRUS Product Code: LFZ PREDICATE DEVICE: Diamedix Is-CMV IgM Capture ELISA Kit (K001767) DEVICE DESCRIPTION: INTENDED USE: The LIAISON® CMV IgM assay uses chemiluminescent immunoassay (CLIA) technology on the LIAIS… | 2000 |
What descends from it? (3)
3 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?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 8.9 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K162969 (DiaSorin, Inc., 2017) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LFZ devicesLFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LFZ
2in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · LFZ
Too few LFZ 510(k)s in any year since 2007 to give a median.
Recalls per year · LFZ
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LFZ
53in 2025
MAUDE reports naming product code LFZ, 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 | — | 1 | 7 |
| 2008 | 0 | — | 0 | 7 |
| 2009 | 0 | — | 1 | 14 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 7 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 2 | — | 0 | 3 |
| 2015 | 0 | — | 0 | 7 |
| 2016 | 0 | — | 0 | 14 |
| 2017 | 2 | — | 0 | 13 |
| 2018 | 1 | — | 0 | 9 |
| 2019 | 0 | — | 0 | 10 |
| 2020 | 0 | — | 0 | 7 |
| 2021 | 0 | — | 0 | 23 |
| 2022 | 2 | — | 1 | 11 |
| 2023 | 0 | — | 0 | 36 |
| 2024 | 0 | — | 0 | 34 |
| 2025 | 0 | — | 1 | 53 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The LIAISON® CMV IgM assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® Analyzer for the qualitative determination of IgM antibodies to human cytomegalovirus (hCMV) in human serum. It is intended to be used as an aid in the diagnosis of acute CMV infection.
The LIAISON® CMV IgG assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® Analyzer for the qualitative determination of IgG antibodies to human cytomegalovirus (hCMV) in human serum. It is intended to be used as an aid in the determination of serological status to CMV.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040290 · printed Nov 3, 2026
Cite this page
510(k) Report. “K040290: Diasorin Liaison CMV Igm/Igg.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040290
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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