510(k) · Cleared
ClearedElecsys Toxo IgM, Elecsys Toxo IgM PreciControl
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics · LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
Cleared on Jun 23, 2017 as substantially equivalent to K923166 (Biomerieux Vitek, Inc., 1993) after a 270-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Jun 23, 2017
- Review
- 270 days
- Class
- Class II
- Product code
- LGD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K923166 (1993). No later device cites it as a predicate yet.
- Root · 1 generation backK923166 Vidas Toxoplasma Gondii Igm AsssayBiomerieux Vitek, Inc. · 1993
- This deviceK162678 Elecsys Toxo IgM, Elecsys Toxo IgM PreciControlRoche Diagnostics · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K923166 | Vidas Toxoplasma Gondii Igm Asssay | Biomerieux Vitek, Inc. | 1993 | — |
| 0 (this device) | K162678 | Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl | Roche Diagnostics | 2017 | — |
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 |
|---|---|---|---|
| * | K923166 | Vidas Toxoplasma Gondii Igm AsssaySummary page 4…) analyte controls (assayed and unassayed) Name 1) LGD, 866.3780 Product Codes 2) JJX, 862.1660 1) VIDAS TOXO IgM Test System (k923166) Predicate Device Roche Diagnostics GmbH in Mannheim, Germany, is 9610126 Establishment Roche Diagnostics… | 1993 |
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.
- 5 other devices also cite its predicate K923166.
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. 2017, 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?
Elecsys Toxo IgM Immunoassay The Elecsys Toxo IgM immunoassay is for the in vitro qualitative detection of IgM antibodies to Toxoplasma gondii in human serum and plasma. This assay may be used as an aid in the diagnosis of an acute or recent Toxoplasma gondii infection in suspected patients and pregnant women. Patient testing must be performed in conjunction with an anti-Toxoplasma gondii IgG antibody assay. The electrochemiluminescence immunoassay…
Read the full statement (119 words)
Elecsys Toxo IgM Immunoassay
The Elecsys Toxo IgM immunoassay is for the in vitro qualitative detection of IgM antibodies to Toxoplasma gondii in human serum and plasma. This assay may be used as an aid in the diagnosis of an acute or recent Toxoplasma gondii infection in suspected patients and pregnant women. Patient testing must be performed in conjunction with an anti-Toxoplasma gondii IgG antibody assay.
The electrochemiluminescence immunoassay “ECLIA” is intended for use on Elecsys and cobas e immuno-assay analyzers. This assay has not been cleared by the FDA for blood/plasma donor screening.
PreciControl Toxo IgM
PreciControl Toxo IgM is used for quality control of the Elecsys Toxo IgM immunoassay on the Elecsys and cobas e immunoassay analyzers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162678 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162678: Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162678
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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