510(k) · Cleared
ClearedLIAISON VZV IgG, LIAISON Control VZV IgG
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DiaSorin, Inc. · LFY Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster
Cleared on Mar 11, 2015 as substantially equivalent to K061820 (DiaSorin, Inc., 2007) after a 26-day review. Its family tree reaches back 2 generations to 1998. 1 later device descends from it.
- Decided
- Mar 11, 2015
- Review
- 26 days
- Class
- Class II
- Product code
- LFY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K981867 (1998). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK981867 IS-Vzu Igg Test SystemDiamedix Corp. · 1998
- 1 generation backK061820 Diasorin Liaison VZV IggDiaSorin, Inc. · 2007
- This deviceK150375 LIAISON VZV IgG, LIAISON Control VZV IgGDiaSorin, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK231214 LIAISON VZV IgG HT, LIAISON Control VZV IgG HTDiaSorin, Inc. · 2023
Most influential descendants
Showing 1 of 1 · See all- K231214LIAISON VZV IgG HT, LIAISON Control VZV IgG HTDiaSorin, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K981867 | IS-Vzu Igg Test System | Diamedix Corp. | 1998 | — |
| −1 | K061820 | Diasorin Liaison VZV Igg | DiaSorin, Inc. | 2007 | — |
| 0 (this device) | K150375 | LIAISON VZV IgG, LIAISON Control VZV IgG | DiaSorin, Inc. | 2015 | — |
| +1 | K231214 | LIAISON VZV IgG HT, LIAISON Control VZV IgG HT | DiaSorin, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 LFY? 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 LFY device
- #1 K231214 LIAISON VZV IgG HT, LIAISON Control VZV IgG HTscore 6.8 · 3 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 |
|---|---|---|---|
| * | K061820 | Diasorin Liaison VZV IggSummary page 4…standards); Microbiology (83) Product Code: LFY, JJX PREDICATE DEVICE: LIAISON® VZV IgG (k061820) DEVICE DESCRIPTION: The LIAISON® VZV IgG is an indirect chemiluminescence immunoassay (CLIA) for qualitative determination of s… | 2007 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K231214 | LIAISON VZV IgG HT, LIAISON Control VZV IgG HT | 2023 | 0 |
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 17 years and passes through 2 companies; a new generation was cleared every 8.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K231214 (DiaSorin, Inc., 2023) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LFY devicesLFY Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · LFY
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · LFY
Too few LFY 510(k)s in any year since 2007 to give a median.
Recalls per year · LFY
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LFY
2in 2024
MAUDE reports naming product code LFY, 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 | 2 | — | 0 | 0 |
| 2008 | 0 | — | 1 | 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 | 1 | — | 0 | 20 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 1 | 2 |
| 2023 | 1 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The DiaSorin LIAISON® VZV IgG uses chemiluminescence immunoassay (CLIA) technology on the LIAISON® Analyzer family for the qualitative detection of specific IgG antibodies to varicella-zoster virus (VZV) in human serum. This assay can be used as an aid in the determination of previous infection of varicella-zoster virus. The assay performance in detecting antibodies to VZV in individuals vaccinated with the FDA-licensed VZV vaccine is unknown. The user…
Read the full statement (141 words)
The DiaSorin LIAISON® VZV IgG uses chemiluminescence immunoassay (CLIA) technology on the LIAISON® Analyzer family for the qualitative detection of specific IgG antibodies to varicella-zoster virus (VZV) in human serum. This assay can be used as an aid in the determination of previous infection of varicella-zoster virus.
The assay performance in detecting antibodies to VZV in individuals vaccinated with the FDA-licensed VZV vaccine is unknown. The user of this assay is responsible for establishing the performance characteristics with VZV vaccinated individuals.
The DiaSorin LIAISON® Control VZV IgG (negative and positive) is intended for use as assayed quality control samples to monitor the performance of the DiaSorin LIAISON® VZV IgG assay on the LIAISON® Analyzer family. The performance characteristics of the LIAISON® Control VZV IgG have not been established for any other assays or instrument platforms different from LIAISON® and LIAISON® XL.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150375 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150375: LIAISON VZV IgG, LIAISON Control VZV IgG.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150375
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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