510(k) · Cleared
ClearedVidas Toxo Igg II (TXG) Assay Model 30 210
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
bioMerieux, Inc. · LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
Cleared on May 22, 2000 after a 231-day review. The FDA summary names its predicate without a number. 4 later devices descend from it.
- Decided
- May 22, 2000
- Review
- 231 days
- Class
- Class II
- Product code
- LGD
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 3 citing it directly.
- This deviceK993319 Vidas Toxo Igg II (TXG) Assay Model 30 210bioMerieux, Inc. · 2000
- Descendant · cites it directly · 1 of its ownK080008 Bioplex 2200 System Torc Igg Kit, Calibrator Set and Control SetBio-Rad Laboratories, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK210596 ARCHITECT Toxo IgGAbbott Laboratories · 2022
- Descendant · 2 generations on · 0 of its ownK120572 Bioplex 2200 Torc IggBio-Rad Laboratories, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK073501 Roche Elecsys Toxo Igg Test System, Roche Elecsys Precicontrol Toxo…Roche Diagnostics Corp. · 2008
Most influential descendants
Showing 4 of 4 · See all- K080008Bioplex 2200 System Torc Igg Kit, Calibrator Set and Control SetBio-Rad Laboratories, Inc. · 2009 · cites it directly1descendant
- K210596ARCHITECT Toxo IgGAbbott Laboratories · 2022 · cites it directly0descendants
- K120572Bioplex 2200 Torc IggBio-Rad Laboratories, Inc. · 2012 · 2 generations on0descendants
- K073501Roche Elecsys Toxo Igg Test System, Roche Elecsys Precicontrol Toxo IggRoche Diagnostics Corp. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K993319 | Vidas Toxo Igg II (TXG) Assay Model 30 210 | bioMerieux, Inc. | 2000 | — |
| +1 | K080008 | Bioplex 2200 System Torc Igg Kit, Calibrator Set and Control Set | Bio-Rad Laboratories, Inc. | 2009 | — |
| +1 | K210596 | ARCHITECT Toxo IgG | Abbott Laboratories | 2022 | — |
| +2 | K120572 | Bioplex 2200 Torc Igg | Bio-Rad Laboratories, Inc. | 2012 | — |
| +1 | K073501 | Roche Elecsys Toxo Igg Test System, Roche Elecsys Precicontrol Toxo Igg | Roche Diagnostics Corp. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2022 | 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? (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 |
|---|---|---|---|
| * | — | Abbott IMx Toxo IgG 2.0 Antibody Assay Named without a submission number |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K080008 (Bio-Rad Laboratories, Inc., 2009) has gone furthest, with 1 descendant of its own.
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 VIDAS® TOXO IgG II (TXG) assay is intended for use with a VIDAS® (Vitek ImmunoDiagnostic Assay System) instrument as a quantitative automated enzyme-linked fluorescent immunoassay (ELFA) for the measurement of Toxoplasma gondii-specific IgG in human serum or plasma (EDTA, heparin). It is intended for use as an aid in determination of immune status. It is not intended for use in testing (screening) blood or plasma donors.
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/K993319 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993319: Vidas Toxo Igg II (TXG) Assay Model 30 210.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993319
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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