510(k) · Cleared
ClearedLIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DiaSorin, Inc. · QFO Zika Virus Serological Reagents
Cleared on Oct 28, 2019 as substantially equivalent to DEN180069 (InBios International, Inc., 2019) after an 89-day review. Its family tree reaches back 1 generation to 2019.
- Decided
- Oct 28, 2019
- Review
- 89 days
- Class
- Class II
- Product code
- QFO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN180069 (2019). No later device cites it as a predicate yet.
- Root · 1 generation backDEN180069 ZIKV Detect 2.0 IgM Capture ELISAInBios International, Inc. · 2019
- This deviceK192046 LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II…DiaSorin, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN180069 | ZIKV Detect 2.0 IgM Capture ELISA | InBios International, Inc. | 2019 | — |
| 0 (this device) | K192046 | LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set | DiaSorin, Inc. | 2019 | — |
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 QFO? 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 QFO device
- #1 K200506 DPP Zika IgM System, DPP Zika IgM System…score -0.5 · 1 generation · 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 |
|---|---|---|---|
| * | DEN180069 | ZIKV Detect 2.0 IgM Capture ELISASummary page 3…l microbiology assays 4. PREDICATE DEVICE: InBios ZIKV DetectTM 2.0 IgM Capture ELISA (DEN180069) 5. INTENDED USE / INDICATIONS FOR USE LIAISON® XL Zika Capture IgM II The DiaSorin LIAISON® XL Zika Capture IgM II as… | 2019 |
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?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate DEN180069.
How does its category compare?
All QFO devicesQFO Zika Virus Serological Reagents: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · QFO
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · QFO
Too few QFO 510(k)s in any year since 2007 to give a median.
Recalls per year · QFO
No recall names QFO since 2007.
Adverse event reports per year · QFO
No MAUDE report names QFO since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 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 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 3 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The DiaSorin LIAISON® XL Zika Capture IgM II assay is intended for the presumptive qualitative detection of Zika virus IgM antibodies in human sera collected from individuals meeting CDC Zika virus clinical criteria (e.g., a history of clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of…
Read the full statement (313 words)
The DiaSorin LIAISON® XL Zika Capture IgM II assay is intended for the presumptive qualitative detection of Zika virus IgM antibodies in human sera collected from individuals meeting CDC Zika virus clinical criteria (e.g., a history of clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiological criteria for which Zika virus testing may be indicated). Specimens from symptomatic patients or returning travelers from endemic areas must be collected not earlier than day 8 after the onset of symptoms or risk of exposure, respectively. Positive results must be confirmed by following the latest CDC guidelines for the diagnosis of Zika virus infection.
Results of this test are intended to be used in combination with clinical observations, patient history, epidemiological information, and other laboratory evidences. Zika IgM levels over the course of illness are not well characterized. IgM levels are variable, may be detectable near day 4 post onset of symptoms and persist up to approximately 12 weeks following initial infection.
Negative results may be seen in specimens collected before day four post onset of symptoms or after the window of detectable IgM closes, and therefore do not preclude the possibility of Zika virus infection, past or present.
This LIAISON® XL Zika Capture IgM II assay is not indicated for testing blood or plasma donors.
The test has to be performed on the LIAISON® XL Analyzer.
The DiaSorin LIAISON® XL Zika Capture IgM II Control Set is intended for use as assayed quality control samples to monitor the performance of the LIAISON® XL Zika Capture IgM II assay. The performance characteristics of the LIAISON® XL Zika Capture IgM II controls have not been established for any other assay or instrument platforms different from the LIAISON® XL.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192046 · printed Nov 3, 2026
Cite this page
510(k) Report. “K192046: LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K192046
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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