510(k) · Cleared
ClearedDiasorin Liaison Toxo Igg and Liaison Toxo Igm Assays
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diasorin S.P.A · LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
Cleared on Feb 8, 2006 as substantially equivalent to K963289 (Incstar Corp., 1997) and 1 other predicate after a 148-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Feb 8, 2006
- Review
- 148 days
- Class
- Class II
- Product code
- LGD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K963289 (1997). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK963289 Incstar Toxoplasma Igm Capture Elisa AssayIncstar Corp. · 1997
- This deviceK052499 Diasorin Liaison Toxo Igg and Liaison Toxo Igm AssaysDiasorin S.P.A · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K963289 | Incstar Toxoplasma Igm Capture Elisa Assay | Incstar Corp. | 1997 | — |
| 0 (this device) | K052499 | Diasorin Liaison Toxo Igg and Liaison Toxo Igm Assays | Diasorin S.P.A | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 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 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? (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 |
|---|---|---|---|
| * | K963289 | Incstar Toxoplasma Igm Capture Elisa AssaySummary page 1…bent Assay, Toxoplasma Product Code: LGD PREDICATE DEVICES: DiaSorin Toxoplasma IgM ELISA Kit (K963289) DEVICE DESCRIPTION: INTENDED USE: The DiaSorin LIAISON® Toxo IgM assay uses chemiluminescent immunoassay (CLIA) technology on… | 1997 |
| * | K981498 | IS-Toxoplasma Igg Test SystemSummary page 5…t Assay, Toxoplasma Product Code: LGD PREDICATE DEVICES: Diamedix Is-Toxoplasma IgG ELISA Kit (K981498) DEVICE DESCRIPTION: INTENDED USE: The LIAISON® Toxo IgG assay uses chemiluminescent immunoassay (CLIA) technology on the LIAIS… | 1998 |
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?
- None of the 2 ancestors has a 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.
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 LIAISON® Toxo IgG assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® Analyzer for the the qualitative determination of specific IgG antibodies to Toxoplasma gondii in human serum. The results of this assay can be used as an aid in the assessment of the patient's serological status to infection with Toxoplasma gondii and in the determination of immune status of individuals including pregnant women. This assay has not been…
Read the full statement (160 words)
The LIAISON® Toxo IgG assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® Analyzer for the the qualitative determination of specific IgG antibodies to Toxoplasma gondii in human serum. The results of this assay can be used as an aid in the assessment of the patient's serological status to infection with Toxoplasma gondii and in the determination of immune status of individuals including pregnant women.
This assay has not been clearedlapproved by the F.D.A for blood/plasma donor screening.
The LIAISON® Toxo IgM assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® Analyzer for the presumptive qualitative determination of IgM antibodies to Toxoplasma gondii in human serum. The LIAISON® Toxo IgM can be used as an aid in the presumptive diagnosis of acute or recent t Toxoplasma gondii infection. It is recommended tha ;he LIAISON® Toxo IgM assay be performed in conjunction with a Toxoplasma gondii IgG assay.
This assay has not been cleared/approved by the F.D.A for blood/plasma donor screening.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052499 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052499: Diasorin Liaison Toxo Igg and Liaison Toxo Igm Assays.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052499
Report an extraction error
Are you the manufacturer?
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