510(k) · Cleared
ClearedLiaison (R) Toxo Igg II, Liaison (R) Control Toxo Igg 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 28, 2013 as substantially equivalent to K981498 (Diamedix Corp., 1998) and 1 other predicate after a 41-day review. Its family tree reaches back 2 generations to 2001. 2 later devices descend from it.
- Decided
- Aug 28, 2013
- Review
- 41 days
- Class
- Class II
- Product code
- LGD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K010668 (2001). 3 ancestors in all, the oldest K981498 (1998). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK010668 Bayer Diagnostics Advia Centaur Rubella Igm AssayBayer Corp. · 2001
- 1 generation backK122397 Liaison Rubella Igm, Liaison Control Rubella IgmDiaSorin, Inc. · 2012
- This deviceK132234 Liaison (R) Toxo Igg II, Liaison (R) Control Toxo Igg IIDiaSorin, Inc. · 2013
- Descendant · cites it directly · 1 of its ownK161139 LIAISON H. pylori IgG, LIAISON H. pylori IgG Control SetDiaSorin, Inc. · 2016
- Descendant · 2 generations on · 0 of its ownK181464 LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control SetDiaSorin, Inc. · 2018
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K010668 | Bayer Diagnostics Advia Centaur Rubella Igm Assay | Bayer Corp. | 2001 | — |
| −1 | K122397 | Liaison Rubella Igm, Liaison Control Rubella Igm | DiaSorin, Inc. | 2012 | — |
| 0 (this device) | K132234 | Liaison (R) Toxo Igg II, Liaison (R) Control Toxo Igg II | DiaSorin, Inc. | 2013 | — |
| +1 | K161139 | LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set | DiaSorin, Inc. | 2016 | — |
| +2 | K181464 | LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set | DiaSorin, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 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 |
|---|---|---|---|
| * | K981498 | IS-Toxoplasma Igg Test SystemSummary page 1…LGD ,Jix PREDICATE DEVICES: Diamedix Is-Toxoplasma iga ELISA Reference K981498 (assay) DiaSorin LIAISON® Control Rubella IgM (K1 2… | 1998 |
| * | K122397 | Liaison Rubella Igm, Liaison Control Rubella IgmSummary page 1…Reference K981498 (assay) DiaSorin LIAISON® Control Rubella IgM (K1 22397) DEVICE DESCRIPTION: INTENDED USE: The LIAISON® Toxo IgS 11assay uses chemiluminescent immunoassay (CLIA) technology on the LIA… | 2012 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K161139 | LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set | 2016 | 1 |
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 12 years and passes through 2 companies; a new generation was cleared every 11.2 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K161139 (DiaSorin, Inc., 2016) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K981498.
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 LIAISON® Toxo IgG 11assay uses chemi luminescent immunoassay (CLIA) technology on the LIAISON® XL Analyzer for the qualitative determination of specific lgG antibodies to Toxoplasma gondli 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 gondil and in the determination of immune status of individuals including pregnant women. This assay has not been…
Read the full statement (145 words)
The LIAISON® Toxo IgG 11assay uses chemi luminescent immunoassay (CLIA) technology on the LIAISON® XL Analyzer for the qualitative determination of specific lgG antibodies to Toxoplasma gondli 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 gondil and in the determination of immune status of individuals including pregnant women. This assay has not been cleared/approved by the FDA for blood/plasma donor screening. U.S. Federal Law restricts this device to sale by or on the order of a physician.
Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients, cord blood, neonatal specimens, or infants.
The LIAISON® Control Toxo IgG 11(negative and positive) is intended for use as assayed quality control samples to monitor the performance of the LIAISON® Toxo IgG 11assay 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/K132234 · printed Nov 5, 2026
Cite this page
510(k) Report. “K132234: Liaison (R) Toxo Igg II, Liaison (R) Control Toxo Igg II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K132234
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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