510(k) Report

510(k) · Cleared

Cleared

C. Difficile Tox a/B II

K030404510(k) TraditionalCleared Apr 24, 200377-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 Apr 24, 2003 as substantially equivalent to K003306 (Techlab, Inc., 2000) and 2 other predicates after a 77-day review. Its family tree reaches back 1 generation to 1997. 2 later devices descend from it.

Decided
Apr 24, 2003
Review
77 days
Class
Class I
Product code
LLH
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K971182 (1997). 3 ancestors in all. 2 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 1 other ancestor1997: 1 other ancestor2005: 1 descendant cleared2009: 1 descendant clearedK971182 · Tox a/B Test · Techlab, Inc. · 19971995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 2 descendants K971182 · Tox a/B Test · Techlab, Inc. · 19970
  1. Root · 1 generation backK971182 Tox a/B TestTechlab, Inc. · 1997
  2. This deviceK030404 C. Difficile Tox a/B IITechlab, Inc. · 2003
  3. Descendant · cites it directly · 1 of its ownK050891 Tox a/B Quick ChekTechlab, Inc. · 2005
  4. Descendant · cites it directly · 0 of its ownK082499 C. Diff Quik Chek CompleteTechlab, Inc. · 2009

Most influential descendants

Showing 2 of 2 · See all
  • 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
−1K971182Tox a/B TestTechlab, Inc.1997—
0 (this device)K030404C. Difficile Tox a/B IITechlab, Inc.2003—
+1K050891Tox a/B Quick ChekTechlab, Inc.2005—
+1K082499C. Diff Quik Chek CompleteTechlab, Inc.2009—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710
200010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200910
FIG. 1 — Lineage of K030404, 1997–2009Source: 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), 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 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? (3)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K003306C. Difficile Tox a/B II
Summary page 1
…oduct, C. DIFFICILE TOXA/B I1 test, was used with the Adaltis Personal Lab Jr. automated microplate analyzer system. The equivalent predicate device 5 1O(k) numbers are K003306, K97 1 182, and K97 1761 respectively. The C. DIFFICILE TOX A/B II test is an enzyme-linked immunoassay for the detection of to:…
Techlab, Inc.2000—
*K971182Tox a/B Test
Summary page 1
…DIFFICILE TOXA/B I1 test, was used with the Adaltis Personal Lab Jr. automated microplate analyzer system. The equivalent predicate device 5 1O(k) numbers are K003306, K97 1 182, and K97 1761 respectively. The C. DIFFICILE TOX A/B II test is an enzyme-linked immunoassay for the detection of to:uins A and…
Techlab, Inc.1997—
*K971761Personallab Automated Microplate Analyzer
Summary page 1
…/B I1 test, was used with the Adaltis Personal Lab Jr. automated microplate analyzer system. The equivalent predicate device 5 1O(k) numbers are K003306, K97 1 182, and K97 1761 respectively. The C. DIFFICILE TOX A/B II test is an enzyme-linked immunoassay for the detection of to:uins A and B in fecal spe…
Biochem Immunosystems (U.S.), Inc.1997—

Also cleared against K003306: 3 other devices →

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
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?

  • None of the 3 ancestors has a recall.
  • Of its descendants, K050891 (Techlab, Inc., 2005) has gone furthest, with 1 descendant of its own.
  • 3 other devices also cite its predicate K003306.

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—

What is it indicated for?

The C. DIFFICILE TOX A/B 11 test is an enzyme immunoassay for the detection of toxins A and B produced by toxigenic strains of Clostridium difficile in fecal specimens from persons suspected of having C. difficile disease and results should be considered in conjunction with the patient history. The test may be performed using either manual or automated (PersonalLab Junior, Adaltis U.S. Inc.) methods.

FOR IN VITRO DIAGNOSTIC USE.

Indications for use as stated in the FDA summary.

Also cleared against K003306

3 other devices cite the same predicate.

  • K082499C. Diff Quik Chek CompleteTechlab, Inc. · 2009
  • K050891Tox a/B Quick ChekTechlab, Inc. · 2005
  • K033479Prospect Clostridium Difficile Toxin a/B Microplate AssayRemel, Inc. · 2004

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/K030404 · printed Nov 6, 2026

Cite this page

510(k) Report. “K030404: 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/K030404

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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