510(k) · Cleared
ClearedRoche Elecsys Toxo Igg Test System, Roche Elecsys Precicontrol Toxo Igg
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
Cleared on Jun 9, 2008 as substantially equivalent to K993319 (bioMerieux, Inc., 2000) after a 179-day review. Its family tree reaches back 1 generation to 2000.
- Decided
- Jun 9, 2008
- Review
- 179 days
- Class
- Class II
- Product code
- LGD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K993319 (2000). No later device cites it as a predicate yet.
- Root · 1 generation backK993319 Vidas Toxo Igg II (TXG) Assay Model 30 210bioMerieux, Inc. · 2000
- This deviceK073501 Roche Elecsys Toxo Igg Test System, Roche Elecsys Precicontrol Toxo…Roche Diagnostics Corp. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K993319 | Vidas Toxo Igg II (TXG) Assay Model 30 210 | bioMerieux, Inc. | 2000 | — |
| 0 (this device) | K073501 | Roche Elecsys Toxo Igg Test System, Roche Elecsys Precicontrol Toxo Igg | Roche Diagnostics Corp. | 2008 | — |
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 |
|---|---|---|---|
| * | K993319 | Vidas Toxo Igg II (TXG) Assay Model 30 210Summary page 2…of primary infection. Substantial The Elecsys Toxo IgG Test System is substantially equivalent to the VIDAS equivalence TOXO IgG II Test System cleared in K993319 510(k) Summary, Continued Substantial equivalence - similarities Elecsys Toxo IgG Test System Intended… | 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.
- 2 other devices also cite its predicate K993319.
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. 2008, 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 Elecsys Toxo IgG immunoassay is for the in vitro quantitative determination of IgG antibodies to Toxoplasma gondi in human serum and Li-heparin, K3-EDTA, and sodium citrate plasma. This assay is intended for use as an aid in the assessment of immune status and as an aid in the diagnosis of primary infection.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Elecsys and cobas e immunoassay analyzers.
Elecsys PreciControl Toxo IgG is used for quality control of the Elecsys Toxo IgG immunoassay on the Elecsys and cobas e immunoassay analyzers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073501 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073501: Roche Elecsys Toxo Igg Test System, Roche Elecsys Precicontrol Toxo Igg.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073501
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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