510(k) · Cleared
Recalled · Class II · 2025Platelia Toxo Igm Kit Model 26211
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad Laboratories · LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
Cleared on Jul 1, 2009 after a 93-day review. FDA’s file for it is a 510(k) statement, which names no predicate. It has been recalled once.
- Decided
- Jul 1, 2009
- Review
- 93 days
- Class
- Class II
- Product code
- LGD
- Recalls
- 1
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 30, 2025 | Class II | Z-2515-2025 | Process control | Due to a risk of false positive results that could lead to unnecessary medical treatment. |
No ancestor or descendant has a Class I 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. 2009, 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 PlateliaTM Toxo IgM kit is an in-vitro diagnostic test kit allowing the qualitative detection of anti-Toxoplasmagondii in human serum or plasma (EDTA, Heparin, Citrate) Note: * Patient testing with the PlateliaTM Toxo IgM assay must be performed in conjunction with an anti-Toxoplasma gondii IgG antibody assay. The PlateliaTM Toxo IgM assay is presumptive for the detection of anti-Toxoplasma gondii IgM antibodies and presumptive for the diagnosis of…
Read the full statement (106 words)
The PlateliaTM Toxo IgM kit is an in-vitro diagnostic test kit allowing the qualitative detection of anti-Toxoplasmagondii in human serum or plasma (EDTA, Heparin, Citrate)
Note:
* Patient testing with the PlateliaTM Toxo IgM assay must be performed in conjunction with an anti-Toxoplasma gondii IgG antibody assay.
The PlateliaTM Toxo IgM assay is presumptive for the detection of anti-Toxoplasma gondii IgM antibodies and presumptive for the diagnosis of acute, recent or reactivated Toxoplasma gondii infection.
The performance of the PlateliaTM Toxo IgM assay has not been established for neonate testing.
The PlateliaTm Toxo igM assay has not been cleared/approved by the FDA for blood/plasma donor screening.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K090847 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090847: Platelia Toxo Igm Kit Model 26211.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090847
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026