510(k) · Cleared
ClearedBio-Rad Platelia Toxo Igm TMB
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad · LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
Cleared on Sep 30, 2002 after a 315-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below).
- Decided
- Sep 30, 2002
- Review
- 315 days
- Class
- Class II
- Product code
- LGD
- Recalls
- None
- Predicates
- 1
The summary cites one number, which could not be confirmed as its predicate (see the table below).
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K089398 | Kallestad Diagnostics Platelia Toxo IgM Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree |
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.
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 Platelia Toxo IgM TMB kit is an in-vitro diagnostic test kit for the qualitative and quantitative detection of anti-Toxoplasma gondii IgM in human serum or plasma (EDTA, Heparin, Citrate). Note: Patient testing with the Platelia Toxo IgM assay must be performed in conjunction with an anti-Toxoplasma gondii IgG antibody assay. The Platelia Toxo IgM assay is presumptive for the detection of anti-Toxoplasma gondii IgM antibodies and presumptive for the…
Read the full statement (110 words)
The Platelia Toxo IgM TMB kit is an in-vitro diagnostic test kit for the qualitative and quantitative detection of anti-Toxoplasma gondii IgM in human serum or plasma (EDTA, Heparin, Citrate).
Note:
Patient testing with the Platelia Toxo IgM assay must be performed in conjunction with an anti-Toxoplasma gondii IgG antibody assay.
The Platelia 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 Platelia Toxo IgM assay has not been established for neonate testing.
The Platelia Toxo IgM assay has not been cleared/approved by the FDA for blood/plasma donor screening.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K013837 · printed Nov 5, 2026
Cite this page
510(k) Report. “K013837: Bio-Rad Platelia Toxo Igm TMB.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K013837
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Page last updated Nov 3, 2026