510(k) · Cleared
ClearedLIAISON VZV IgG HT, LIAISON Control VZV IgG HT
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 Oct 27, 2023 as substantially equivalent to K150375 (DiaSorin, Inc., 2015) after a 182-day review. Its family tree reaches back 3 generations to 1998.
- Decided
- Oct 27, 2023
- Review
- 182 days
- Class
- Class II
- Product code
- LFY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K981867 (1998). No later device cites it as a predicate yet.
- Root · 3 generations backK981867 IS-Vzu Igg Test SystemDiamedix Corp. · 1998
- 2 generations backK061820 Diasorin Liaison VZV IggDiaSorin, Inc. · 2007
- 1 generation backK150375 LIAISON VZV IgG, LIAISON Control VZV IgGDiaSorin, Inc. · 2015
- This deviceK231214 LIAISON VZV IgG HT, LIAISON Control VZV IgG HTDiaSorin, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K981867 | IS-Vzu Igg Test System | Diamedix Corp. | 1998 | — |
| −2 | K061820 | Diasorin Liaison VZV Igg | DiaSorin, Inc. | 2007 | — |
| −1 | K150375 | LIAISON VZV IgG, LIAISON Control VZV IgG | DiaSorin, Inc. | 2015 | — |
| 0 (this device) | K231214 | LIAISON VZV IgG HT, LIAISON Control VZV IgG HT | DiaSorin, Inc. | 2023 | — |
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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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 |
|---|---|---|---|
| * | K150375 | LIAISON VZV IgG, LIAISON Control VZV IgGSummary page 4…LFY PREDICATE DEVICE: LIAISON® VZV IgG, LIAISON® Control VZV IgG (k150375) DEVICE DESCRIPTION: The LIAISON® VZV IgG HT is an indirect chemiluminescence immunoassay (CLIA) for qualitative detection of sp… | 2015 |
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 25 years and passes through 2 companies; a new generation was cleared every 8.4 years on median.
- None of the 3 ancestors has a recall.
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. 2023, 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 LIAISON VZV IgG HT assay uses chemiluminescent immunoassay (CLIA) technology for the in vitro qualitative detection of specific IgG antibodies to varicella-zoster virus (VZV) in human serum (with gel and without gel-SST), dipotassium EDTA (K2- EDTA), lithium heparin and sodium heparin plasma samples. This assay is intended as an aid in the determination of previous infection of varicella-zoster virus. The test must be performed on the LIAISON XL…
Read the full statement (104 words)
The LIAISON VZV IgG HT assay uses chemiluminescent immunoassay (CLIA) technology for the in vitro qualitative
detection of specific IgG antibodies to varicella-zoster virus (VZV) in human serum (with gel and without gel-SST),
dipotassium EDTA (K2- EDTA), lithium heparin and sodium heparin plasma samples. This assay is intended as an aid in
the determination of previous infection of varicella-zoster virus. The test must be performed on the LIAISON XL
Analyzer. 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231214 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231214: LIAISON VZV IgG HT, LIAISON Control VZV IgG HT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231214
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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