510(k) Report

510(k) · Cleared

Cleared

Vidas Toxoplasma Gondii Igm Asssay

K923166510(k) TraditionalCleared Feb 25, 1993241-day reviewClass II21 CFR 866.3780

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Biomerieux Vitek, Inc. · LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii

Cleared on Feb 25, 1993 after a 241-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.

Decided
Feb 25, 1993
Review
241 days
Class
Class II
Product code
LGD
Recalls
None
Predicates
0

6 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 2015: 1 descendant cleared2024: 1 descendant cleared2017: 2 descendants cleared2002: 1 descendant cleared2011: 1 descendant cleared1990200020102020
  1. This deviceK923166 Vidas Toxoplasma Gondii Igm AsssayBiomerieux Vitek, Inc. · 1993
  2. Descendant · cites it directly · 0 of its ownK233932 Alinity i Toxo IgMAbbott Laboratories · 2024
  3. Descendant · cites it directly · 0 of its ownK162678 Elecsys Toxo IgM, Elecsys Toxo IgM PreciControlRoche Diagnostics · 2017
  4. Descendant · cites it directly · 0 of its ownK170509 BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex…Bio-Rad Laboratories · 2017
  5. Descendant · cites it directly · 0 of its ownK141133 VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG…Biomerieux · 2015 · Recalled
  6. Descendant · cites it directly · 0 of its ownK101946 Vidas Toxo Igg AviditybioMerieux, Inc. · 2011 · Recalled

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2002: 12011: 12015: 12017: 22024: 1
2002high 2 (2017) · low 0 (2003)2026

Most influential descendants

Showing 5 of 6 · See all
  • K233932Alinity i Toxo IgMAbbott Laboratories · 2024 · cites it directly0descendants
  • K162678Elecsys Toxo IgM, Elecsys Toxo IgM PreciControlRoche Diagnostics · 2017 · cites it directly0descendants
  • K170509BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM…Bio-Rad Laboratories · 2017 · cites it directly0descendants
  • K141133VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M, VIDAS…Biomerieux · 2015 · cites it directly0descendants
  • K101946Vidas Toxo Igg AviditybioMerieux, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K923166Vidas Toxoplasma Gondii Igm AsssayBiomerieux Vitek, Inc.1993—
+1K233932Alinity i Toxo IgMAbbott Laboratories2024—
+1K162678Elecsys Toxo IgM, Elecsys Toxo IgM PreciControlRoche Diagnostics2017—
+1K170509BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC…Bio-Rad Laboratories2017—
+1K141133VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M…Biomerieux20154
+1K101946Vidas Toxo Igg AviditybioMerieux, Inc.20111

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
201110
201510
201720
202410
FIG. 1 — Lineage of K923166, 1993–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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. #1 K242022 Access Toxo IgGscore 9.7 · 3 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (6)

6 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K233932Alinity i Toxo IgMAbbott Laboratories20240
K162678Elecsys Toxo IgM, Elecsys Toxo IgM PreciControlRoche Diagnostics20170
K170509BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM…Bio-Rad Laboratories20170
K141133VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M, VIDAS…Biomerieux20150
K101946Vidas Toxo Igg AviditybioMerieux, Inc.20110
K012075Immulite Toxoplasma Igm, Model LKTM1 and LKTM2, Immulite 2000 Toxoplasma Igm, Model…Diagnostic Products Corp.20020

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, K233932 (Abbott Laboratories, 2024) has gone furthest, with 0 descendants of its own.

How does its category compare?

All LGD devices

LGD 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

2008: 22009: 12011: 22013: 22015: 12017: 12022: 12024: 22025: 1
2007high 2 (2008) · low 0 (2007)2026

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

2007: 22008: 12010: 12021: 1
2007high 2 (2007) · low 0 (2009)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LGD

89in 2025

2007: 42008: 142009: 912010: 712011: 1152012: 752013: 352014: 222015: 1212016: 1402017: 1732018: 1002019: 592020: 872021: 382022: 732023: 1182024: 812025: 89
2007high 173 (2017) · low 4 (2007)2025

MAUDE reports naming product code LGD, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—24
20082—114
20091—091
20100—171
20112—0115
20120—075
20132—035
20140—022
20151—0121
20160—0140
20171—0173
20180—0100
20190—059
20200—087
20210—138
20221—073
20230—0118
20242—081
20251—089
20260—0—

More from Biomerieux Vitek, Inc.

180 FDA decisions under this applicant name. See the company

  • N50510/S146Vitek 2 System, Models Vitek 2 and Vitek 2 XLBiomerieux Vitek, Inc. · 2001
  • N50510/S145Vitek 2 Gram Positive Ast Panel for Streptococcus Pneumoniae: Trimethoprim/SulfamethoxazoleBiomerieux Vitek, Inc. · 2001
  • N50510/S143Vitek Gram Positive Susceptibility (GPS) Card for GatifloxacinBiomerieux Vitek, Inc. · 2001
  • N50510/S144Vitek Gram Positive Susceptibility (GPS) Card for Quinupristin/DalfopristinBiomerieux Vitek, Inc. · 2001
  • N50510/S142Vitek Gram Positive Ast for MoxifloxacinBiomerieux Vitek, Inc. · 2001

Recent decisions in LGD

The LGD category page

  • K242022Access Toxo IgGBeckman Coulter, Inc. · 2025
  • K242095Access Toxo IgM IIBeckman Coulter, Inc. · 2024
  • K233932Alinity i Toxo IgMAbbott Laboratories · 2024
  • K210596ARCHITECT Toxo IgGAbbott Laboratories · 2022
  • K162678Elecsys Toxo IgM, Elecsys Toxo IgM PreciControlRoche Diagnostics · 2017

https://510kreport.com/device/K923166 · printed Nov 6, 2026

Cite this page

510(k) Report. “K923166: Vidas Toxoplasma Gondii Igm Asssay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K923166

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026