510(k) Report

510(k) · Cleared

Cleared

C. Difficile Tox a/B II

K003306510(k) SpecialCleared Nov 22, 200033-day reviewClass I21 CFR 866.2660

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

Techlab, Inc. · LLH Reagents, Clostridium Difficile Toxin

Cleared on Nov 22, 2000 after a 33-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.

Decided
Nov 22, 2000
Review
33 days
Class
Class I
Product code
LLH
Recalls
None
Predicates
0

4 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2005: 1 descendant cleared2009: 1 descendant cleared2003: 1 descendant cleared2004: 1 descendant cleared200020052010201520202025
  1. This deviceK003306 C. Difficile Tox a/B IITechlab, Inc. · 2000
  2. Descendant · cites it directly · 2 of its ownK033479 Prospect Clostridium Difficile Toxin a/B Microplate AssayRemel, Inc. · 2004
  3. Descendant · cites it directly · 2 of its ownK030404 C. Difficile Tox a/B IITechlab, Inc. · 2003
  4. Descendant · cites it directly · 1 of its ownK050891 Tox a/B Quick ChekTechlab, Inc. · 2005
  5. Descendant · cites it directly · 0 of its ownK082499 C. Diff Quik Chek CompleteTechlab, Inc. · 2009

Most influential descendants

Showing 4 of 4 · See all
  • K033479Prospect Clostridium Difficile Toxin a/B Microplate AssayRemel, Inc. · 2004 · cites it directly2descendants
  • K030404C. Difficile Tox a/B IITechlab, Inc. · 2003 · cites it directly2descendants
  • K050891Tox a/B Quick ChekTechlab, Inc. · 2005 · cites it directly1descendant
  • K082499C. Diff Quik Chek CompleteTechlab, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K003306C. Difficile Tox a/B IITechlab, Inc.2000—
+1K033479Prospect Clostridium Difficile Toxin a/B Microplate AssayRemel, Inc.2004—
+1K030404C. Difficile Tox a/B IITechlab, Inc.2003—
+1K050891Tox a/B Quick ChekTechlab, Inc.2005—
+1K082499C. Diff Quik Chek CompleteTechlab, Inc.2009—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200410
200510
200910
FIG. 1 — Lineage of K003306, 2000–2009Source: 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 LLH? 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 LLH device

  1. #1 K193490 SensiTox C. difficile Toxin Testscore 1.6 · 1 generation · no Class I recall
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? (4)

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

NumberDeviceApplicantDecidedDescendants
K033479Prospect Clostridium Difficile Toxin a/B Microplate AssayRemel, Inc.20042
K030404C. Difficile Tox a/B IITechlab, Inc.20032
K050891Tox a/B Quick ChekTechlab, Inc.20051
K082499C. Diff Quik Chek CompleteTechlab, Inc.20090

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, K033479 (Remel, Inc., 2004) has gone furthest, with 2 descendants of its own.

How does its category compare?

All LLH devices

LLH Reagents, Clostridium Difficile Toxin: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LLH

1in 2021

2007: 12008: 22009: 32010: 12021: 1
2007high 3 (2009) · low 0 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LLH

84in 2009

2009: 84 days median
2007high 84 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LLH

1in 2021

2010: 12012: 22013: 22021: 1
2007high 2 (2012) · low 0 (2007)2026

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

Adverse event reports per year · LLH

1in 2025

2010: 12021: 12022: 12023: 12024: 12025: 1
2007high 1 (2010) · low 0 (2007)2025

MAUDE reports naming product code LLH, 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
20071—00
20082—00
200938400
20101—11
20110—00
20120—20
20130—20
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20211—11
20220—01
20230—01
20240—01
20250—01
20260—0—

More from Techlab, Inc.

36 FDA decisions under this applicant name. See the company

  • K191442Campylobacter ChekTechlab, Inc. · 2019
  • K191456Campylobacter Quik ChekTechlab, Inc. · 2019
  • K181379H. Pylori Quik ChekTechlab, Inc. · 2018
  • K181400H. Pylori Chek™Techlab, Inc. · 2018
  • K173217Campylobacter Quik ChekTechlab, Inc. · 2018

Recent decisions in LLH

The LLH category page

  • K193490SensiTox C. difficile Toxin TestFirst Light Diagnostics, Inc. · 2021
  • K102242Osom C. Difficile Toxin a/B TestGenzyme Corporation · 20101 recall
  • K091109Xpert C. DifficileCepheid · 2009
  • K090239Progastro CD AssayProdesse, Inc. · 2009
  • K082499C. Diff Quik Chek CompleteTechlab, Inc. · 2009

https://510kreport.com/device/K003306 · printed Nov 6, 2026

Cite this page

510(k) Report. “K003306: C. Difficile Tox a/B II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003306

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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