510(k) Report

510(k) · Cleared

Cleared

Vidas Thyroxine (T4) Assay (T4)

K926393510(k) TraditionalCleared May 13, 1993143-day reviewClass II21 CFR 862.1700

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

Biomerieux Vitek, Inc. · KLI Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine

Cleared on May 13, 1993 after a 143-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
May 13, 1993
Review
143 days
Class
Class II
Product code
KLI
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2015: 1 descendant cleared1990200020102020
  1. This deviceK926393 Vidas Thyroxine (T4) Assay (T4)Biomerieux Vitek, Inc. · 1993
  2. Descendant · cites it directly · 0 of its ownK141133 VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG…Biomerieux · 2015 · Recalled

Most influential descendants

Showing 1 of 1 · See all
  • K141133VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M, VIDAS…Biomerieux · 2015 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K926393Vidas Thyroxine (T4) Assay (T4)Biomerieux Vitek, Inc.1993—
+1K141133VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M…Biomerieux20154

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
FIG. 1 — Lineage of K926393, 1993–2015Source: 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 KLI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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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? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K141133VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M, VIDAS…Biomerieux20150

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, K141133 (Biomerieux, 2015) has gone furthest, with 0 descendants of its own.

How does its category compare?

All KLI devices

KLI Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KLI

1in 2016

2009: 12011: 12013: 12016: 1
2007high 1 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KLI

Too few KLI 510(k)s in any year since 2007 to give a median.

Recalls per year · KLI

2in 2021

2010: 12011: 12021: 22026 (partial year): 1
2007high 2 (2021) · low 0 (2007)2026

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

Adverse event reports per year · KLI

3in 2021

2010: 32011: 72012: 22014: 52018: 32019: 12021: 3
2007high 7 (2011) · low 0 (2007)2025

MAUDE reports naming product code KLI, 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—00
20080—00
20091—00
20100—13
20111—17
20120—02
20131—00
20140—05
20150—00
20161—00
20170—00
20180—03
20190—01
20200—00
20210—23
20220—00
20230—00
20240—00
20250—00
20260—1—

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 KLI

The KLI category page

  • K160495VITROS® Automation SolutionsOrtho-Clinical Diagnostics, Inc. · 20161 recall
  • K131515Ace -GT Reagent; Ace Lipase Ragent; Ace T4 ReagentAlfa Wassermann · 2013
  • K103484GSP Neonatal Thyroxine (T4)Wallac Oy, A Subsidiary of Perkinelmer, Inc. · 2011
  • K082638Advia Centaur System with Streamlab Analytical WorkcellSiemens Healthcare Diagnostics, Inc. · 20093 recalls
  • K030860Accubind Neonatal T4 Microplate Eia, Model 2625-300Monobind · 2003

https://510kreport.com/device/K926393 · printed Nov 6, 2026

Cite this page

510(k) Report. “K926393: Vidas Thyroxine (T4) Assay (T4).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K926393

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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