510(k) · Cleared
ClearedLiaison Toxo Igm II, Liaison Control Toxo Igm II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DiaSorin, Inc. · LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
Cleared on Aug 9, 2013 as substantially equivalent to K001707 (Diamedix Corp., 2000) after an 81-day review. Its family tree reaches back 1 generation to 2000.
- Decided
- Aug 9, 2013
- Review
- 81 days
- Class
- Class II
- Product code
- LGD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K001707 (2000). No later device cites it as a predicate yet.
- Root · 1 generation backK001707 Diamedix IS-Toxoplasma Igm Capture Test SystemDiamedix Corp. · 2000
- This deviceK131441 Liaison Toxo Igm II, Liaison Control Toxo Igm IIDiaSorin, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K001707 | Diamedix IS-Toxoplasma Igm Capture Test System | Diamedix Corp. | 2000 | — |
| 0 (this device) | K131441 | Liaison Toxo Igm II, Liaison Control Toxo Igm II | DiaSorin, Inc. | 2013 | — |
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 LGD? 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 LGD device
- #1 K242022 Access Toxo IgGscore 9.7 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K001707 | Diamedix IS-Toxoplasma Igm Capture Test SystemSummary page 3…Characteristic DiaSorin LIAISON®Toxo IgM 11 Diamedix Is-Toxoplasma IgM Capture Test Kit (K001707) The LIAISON® Toxo IgM II assay The Diamedix Is-Toxoplasma IgM uses ch… | 2000 |
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.
How does its category compare?
All LGD devicesLGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · LGD
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LGD
Too few LGD 510(k)s in any year since 2007 to give a median.
Recalls per year · LGD
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LGD
89in 2025
MAUDE reports naming product code LGD, 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 | — | 2 | 4 |
| 2008 | 2 | — | 1 | 14 |
| 2009 | 1 | — | 0 | 91 |
| 2010 | 0 | — | 1 | 71 |
| 2011 | 2 | — | 0 | 115 |
| 2012 | 0 | — | 0 | 75 |
| 2013 | 2 | — | 0 | 35 |
| 2014 | 0 | — | 0 | 22 |
| 2015 | 1 | — | 0 | 121 |
| 2016 | 0 | — | 0 | 140 |
| 2017 | 1 | — | 0 | 173 |
| 2018 | 0 | — | 0 | 100 |
| 2019 | 0 | — | 0 | 59 |
| 2020 | 0 | — | 0 | 87 |
| 2021 | 0 | — | 1 | 38 |
| 2022 | 1 | — | 0 | 73 |
| 2023 | 0 | — | 0 | 118 |
| 2024 | 2 | — | 0 | 81 |
| 2025 | 1 | — | 0 | 89 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The DiaSorin LIAISON® Toxo IgM II assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON XL Analyzer for the qualitative determination of IgM antibodies to Toxoplasma gondii in human serum. The LIAISON Toxo IgM II is intended for use as an aid in the presumptive diagnosis of acute or recent Toxoplasma gondii infection, including pregnant women. It is recommended, that the LIAISON Toxo IgM II assay be performed in conjunction with a…
Read the full statement (122 words)
The DiaSorin LIAISON® Toxo IgM II assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON XL Analyzer for the qualitative determination of IgM antibodies to Toxoplasma gondii in human serum. The LIAISON Toxo IgM II is intended for use as an aid in the presumptive diagnosis of acute or recent Toxoplasma gondii infection, including pregnant women. It is recommended, that the LIAISON Toxo IgM II assay be performed in conjunction with a Toxoplasma gondii IgG assay. This assay has not been cleared/approved by the FDA for blood/plasma donor screening.
The DiaSorin LIAISON® Control Toxo IgM II is intended for use as assayed quality control samples to monitor the performance of the DiaSorin LIAISON® Toxo IgM II assay on the LIAISON® XL Analyzer.
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/K131441 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131441: Liaison Toxo Igm II, Liaison Control Toxo Igm II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131441
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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