510(k) Report

510(k) · Cleared

Cleared

C. Diff Quik Chek Complete

K082499510(k) TraditionalCleared Mar 26, 2009209-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 Mar 26, 2009 as substantially equivalent to K053572 (Techlab, Inc., 2006) and 12 other predicates after a 209-day review. Its family tree reaches back 4 generations to 1991.

Decided
Mar 26, 2009
Review
209 days
Class
Class I
Product code
LLH
Recalls
None
Predicates
13

Its longest line of descent runs back 4 generations to K911958 (1991). 18 ancestors in all, the oldest K870864 (1987). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2006: 1 other ancestor2004: 2 other ancestors2003: 3 other ancestors2000: 1 other ancestor1998: 1 other ancestor1994: 1 other ancestor1993: 2 other ancestors1987: 1 other ancestor1997: 2 other ancestorsK911958 · 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. · 2004K050891 · Tox a/B Quick Chek · Techlab, Inc. · 2005198519901995200020052010
Other ancestors, by generation 1 generation back: 10 other ancestors2 generations back: 4 other ancestors K050891 · Tox a/B Quick Chek · Techlab, Inc. · 2005K033479 · 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 · 4 generations backK911958 Cytoclone a & B EiaCambridge Biotech Corp. · 1991
  2. 3 generations backK993914 Premier Toxins a&B, Model 616096Meridian Diagnostics, Inc. · 1999 · Recalled
  3. 2 generations backK033479 Prospect Clostridium Difficile Toxin a/B Microplate AssayRemel, Inc. · 2004
  4. 1 generation backK050891 Tox a/B Quick ChekTechlab, Inc. · 2005
  5. This deviceK082499 C. Diff Quik Chek CompleteTechlab, Inc. · 2009
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K911958Cytoclone a & B EiaCambridge Biotech Corp.1991—
−3K993914Premier Toxins a&B, Model 616096Meridian Diagnostics, Inc.19992
−2K033479Prospect Clostridium Difficile Toxin a/B Microplate AssayRemel, Inc.2004—
−1K050891Tox a/B Quick ChekTechlab, Inc.2005—
0 (this device)K082499C. Diff Quik Chek CompleteTechlab, Inc.2009—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198710
199320
199410
199720
199810
200010
200330
200420
200610
FIG. 1 — Lineage of K082499, 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? (15)

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
*K053572C. Diff Quik Chek
Summary page 3
…C. difficile GDH C. difficile specimens disease C. DIFF QUIK K053572 Detection of Rapid Highly specific Persons CHEKI test C. difficile mem…
Techlab, Inc.2006—
*K030992C. Diff Chek - 60
Summary page 3
…and CC BHIb C. difficile available. specimens broth disease C. DIFF CHEK TM K030992 Detection of ELISA Highly specific Persons - 60 C. difficile…
Techlab, Inc.2003—
*K870864Culturette Brand CDT Clostridium Difficile Test
Summary page 3
…C. difficile GDH C. difficile specimens disease BD K870864 Detection of Latex Antibodies Persons CULTURETTE TM C. difficile agg…
Marion Laboratories, Inc.1987—
*K924979Immunocard (TM) C. Difficile
Summary page 3
…C. difficile GDH C. difficile specimens disease ImmunoCard® K924979 Detection of Lateral flow Highly specific Persons C. difficile EIA C. difficile mem…
Meridian Diagnostics, Inc.1993—
*K935296Clostridium Difficile Tox-B Test
Summary page 4
…ge 4 === C. DIFFQUIK CHEK COMPLETE2m 510(k) For detection of toxins A and B: Tissue culture K935296 Detection of Tissue Cell Persons assay (TOX-B C. difficile culture monol…
Techlab, Inc.1994—
*K050891Tox a/B Quick Chek
Summary page 4
…ens C. difficile C. difficile toxins A and B disease TOX A/B QUIK K050891 Detection of Rapid Highly specific Persons CHEK®test C. difficile membrane anti…
Techlab, Inc.2005—
*K003306C. Difficile Tox a/B II
Summary page 4
…ens neutralizing C. difficile antiserum disease C. DIFFICILE K003306 Detection of Microassay Highly specific Persons TOX A/B IIM T C. difficile…
Techlab, Inc.2000—
*K030404C. Difficile Tox a/B II
Summary page 4
…ifficile ELISA antibodies suspected of toxin in fecal against having K030404 specimens C. difficile C. difficile…
Techlab, Inc.2003—
*K993914Premier Toxins a&B, Model 616096
Summary page 4
…ens C. difficile C. difficile toxins A and B disease PremierTM Toxins K993914 Detection of Microassay Highly specific Persons A&B C. difficile ELISA antib…
Meridian Diagnostics, Inc.19992
*K033479Prospect Clostridium Difficile Toxin a/B Microplate Assay
Summary page 4
…ens C. difficile C. difficile toxins A and B disease ProSpecT® K033479 Detection of Microassay Highly specific Persons Clostridium C. difficile ELISA antib…
Remel, Inc.2004—
*K041003Immunocard Toxins a & B, Model 712050
Summary page 4
…ens C. difficile C. difficile toxins A and B disease ImmunoCards ' K041003 Detection of Rapid Highly specific Persons Toxins A&B C. difficile membrane antib…
Meridian Bioscience, Inc.20041
*K041951Xpect Clostridium Difficile Toxin a/B
Summary page 4
…ens C. difficile C. difficile toxins A and B disease X/pect TM K041951 Detection of Rapid Highly specific Persons Clostridium C. difficile membrane antib…
Remel, Inc.2004—
*K974881Triage C. Difficile, Triage C. Difficile Panel, Triage C. Difficile Toxin a
Summary page 3
…and other C. difficile specimens proteins disease Triage® Micro K974881 Detection of Flow through Highly specific Persons C. difficile Panel, C. difficile mem…
Biosite Incorporated19981
*—C. difficile Culture Media such as cycloserine-cefoxitin fructose agar (CCFA)
Named without a submission number
—
*—C. difficile Toxin/Antitoxin along with human foreskin monolayer tissue cultured cells…
Named without a submission number
—

Also cleared against K053572: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 18 years and passes through 4 companies; a new generation was cleared every 4.2 years on median.
  • 3 of the 18 ancestors have a recall of any class.
  • 2 other devices also cite its predicate K053572.

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. 2009, this device’s year, is highlighted.

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. DIFF QUIK CHEK COMPLETE rM test is a rapid, membrane enzyme immunoassay for the simultaneous detection of Clostridium difficile glutamate dehydrogenase antigen and toxins A and B in a single reaction well. The test detects C. difficile antigen, glutamate dehydrogenase, as a screen for the presence of C. difficile and confirms the presence of toxigenic C. difficile by detecting toxins A and B in fecal specimens from persons suspected of havihg C. difficile disease. The test is to be used as an aid in the diagnosis of C. difficile disease. As with other C. difficile tests, results should be considered in conjunction with the patient history.

Indications for use as stated in the FDA summary.

Also cleared against K053572

2 other devices cite the same predicate.

  • K132010Vidas C Difficile GDHBiomerieux S.A. · 2013
  • K112048Immunocard C. Difficile GDHMeridian Bioscience, Inc. · 2011

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
  • K173219Campylobacter 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
  • K081920BD Geneohm Cdiff AssayBd Diagnostics (Geneohm Sciences, Inc.) · 20084 recalls

https://510kreport.com/device/K082499 · printed Nov 4, 2026

Cite this page

510(k) Report. “K082499: C. Diff Quik Chek Complete.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082499

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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