510(k) Report

510(k) · Cleared

Cleared

Tox a/B Quick Chek

K050891510(k) TraditionalCleared Jul 25, 2005108-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 Jul 25, 2005 as substantially equivalent to K935296 (Techlab, Inc., 1994) and 7 other predicates after a 108-day review. Its family tree reaches back 3 generations to 1991. 1 later device descends from it.

Decided
Jul 25, 2005
Review
108 days
Class
Class I
Product code
LLH
Recalls
None
Predicates
8

Its longest line of descent runs back 3 generations to K911958 (1991). 11 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2004: 2 other ancestors2003: 1 other ancestor2000: 1 other ancestor1994: 1 other ancestor1993: 1 other ancestor1997: 2 other ancestors2009: 1 descendant clearedK911958 · Cytoclone a & B Eia · Cambridge Biotech Corp. · 1991K993914 · Premier Toxins a&B, Model 616096 · Meridian Diagnostics, Inc. · 1999 · recalledK033479 · Prospect Clostridium Difficile Toxin a/B Microplate Assay · Remel, Inc. · 20041990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 6 other ancestors2 generations back: 2 other ancestors 1 generation forward: 1 descendant K033479 · Prospect Clostridium Difficile Toxin a/B Microplate Assay · Remel, Inc. · 2004K993914 · Premier Toxins a&B, Model 616096 · Meridian Diagnostics, Inc. · 1999 · recalledK911958 · Cytoclone a & B Eia · Cambridge Biotech Corp. · 19910
  1. Root · 3 generations backK911958 Cytoclone a & B EiaCambridge Biotech Corp. · 1991
  2. 2 generations backK993914 Premier Toxins a&B, Model 616096Meridian Diagnostics, Inc. · 1999 · Recalled
  3. 1 generation backK033479 Prospect Clostridium Difficile Toxin a/B Microplate AssayRemel, Inc. · 2004
  4. This deviceK050891 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 1 of 1 · See all
  • K082499C. Diff Quik Chek CompleteTechlab, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K911958Cytoclone a & B EiaCambridge Biotech Corp.1991—
−2K993914Premier Toxins a&B, Model 616096Meridian Diagnostics, Inc.19992
−1K033479Prospect Clostridium Difficile Toxin a/B Microplate AssayRemel, Inc.2004—
0 (this device)K050891Tox a/B Quick ChekTechlab, Inc.2005—
+1K082499C. Diff Quik Chek CompleteTechlab, Inc.2009—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199310
199410
199720
200010
200310
200420

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
FIG. 1 — Lineage of K050891, 1991–2009Source: 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? (8)

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
*K935296Clostridium Difficile Tox-B Test
Summary page 1
…April 5, 2005 Product and Trade Name TOXAIB QUIK CHEKTM Classification 21 CFR 866.2660 Predicate Devices * C. DIFFICILE TOX-B TEST (K935296) - TECHLAB, Inc., Blacksburg, VA * C. difficile toxin/antitoxin (K(923463) - TECH-LAB, Inc., Blacksburg, VA * C. DI…
Techlab, Inc.1994—
*K923463Clostridium Difficile Toxin/Antitoxin Kit
Summary page 1
…on 21 CFR 866.2660 Predicate Devices * C. DIFFICILE TOX-B TEST (K935296) - TECHLAB, Inc., Blacksburg, VA * C. difficile toxin/antitoxin (K(923463) - TECH-LAB, Inc., Blacksburg, VA * C. DIFFICILE TOX A/B JJTM (K003306 and K(030404) - TECHLAB, Inc., Blacksburg, VA…
Techlab, Inc.1993—
*K003306C. Difficile Tox a/B II
Summary page 1
…OX-B TEST (K935296) - TECHLAB, Inc., Blacksburg, VA * C. difficile toxin/antitoxin (K(923463) - TECH-LAB, Inc., Blacksburg, VA * C. DIFFICILE TOX A/B JJTM (K003306 and K(030404) - TECHLAB, Inc., Blacksburg, VA * Premier TmToxins A&B (K(993914) - Meridian Bioscience, Inc., Cincinnati, O…
Techlab, Inc.2000—
*K030404C. Difficile Tox a/B II
Summary page 2
…antibodies suspected of and fecal specimens against C. having C. KK030404 difficile toxins A difficile disease…
Techlab, Inc.2003—
*K993914Premier Toxins a&B, Model 616096
Summary page 2
…difficile toxins A difficile disease and B Premier TM Toxins K993914 Detection of C. Microtiter Highly specific Persons A&B difficile toxin…
Meridian Diagnostics, Inc.19992
*K033479Prospect Clostridium Difficile Toxin a/B Microplate Assay
Summary page 2
…difficile toxins A difficile disease and B ProSpecT® K033479 Detection of C. Microtiter Highly specific Persons Clostridium difficile toxin…
Remel, Inc.2004—
*K041003Immunocard Toxins a & B, Model 712050
Summary page 2
…difficile toxins A difficile disease and B ImmunoCard® K041003 Detection of C. Rapid Highly specific Persons Toxins A&B difficile toxin…
Meridian Bioscience, Inc.20041
*K041951Xpect Clostridium Difficile Toxin a/B
Summary page 1
…(1(033479) - Remel, Lenexa, KS * ImrnunoCard4 Toxins A&B (KO041003) - Meridian Bioscience, Inc., Cincinnati, OH * XpeCtTM Clostridium difficile Toxin A/B (K041951) - Remel Inc., Lenexa, KS Intended Use The TOX A/B QUIK CHEKm test is a rapid immunoassay for detecting Clostridiumn…
Remel, Inc.2004—

Also cleared against K935296: 2 other devices →

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
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?

  • The line of descent spans 14 years and passes through 4 companies; a new generation was cleared every 4.2 years on median.
  • 2 of the 11 ancestors have a recall of any class.
  • Of its descendants, K082499 (Techlab, Inc., 2009) has gone furthest, with 0 descendants of its own.
  • 2 other devices also cite its predicate K935296.

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 TOXA/B QUIK CHEKM test is a rapid immunoassay for detecting Clostridium difficile toxins A and B in fecal specimens from persons suspected of having C. difficile disease. The test is to be used as an aid in the diagnosis of C. difficile disease and results should be considered in conjunction with the patient history. FOR IN VITRO DIAGNOSTIC USE.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K935296

2 other devices cite the same predicate.

  • K082499C. Diff Quik Chek CompleteTechlab, Inc. · 2009
  • K081920BD Geneohm Cdiff AssayBd Diagnostics (Geneohm Sciences, Inc.) · 20084 recalls

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/K050891 · printed Nov 4, 2026

Cite this page

510(k) Report. “K050891: Tox a/B Quick Chek.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K050891

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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