510(k) Report

510(k) · Cleared

Cleared

C. Diff Quik Chek

K053572510(k) TraditionalCleared Apr 26, 2006125-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. · MCB Antigen, C. Difficile

Cleared on Apr 26, 2006 as substantially equivalent to K030992 (Techlab, Inc., 2003) and 4 other predicates after a 125-day review. Its family tree reaches back 1 generation to 1987. 3 later devices descend from it.

Decided
Apr 26, 2006
Review
125 days
Class
Class I
Product code
MCB
Recalls
None
Predicates
5

Its longest line of descent runs back 1 generation to K870864 (1987). 5 ancestors in all. 3 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2003: 2 other ancestors1998: 1 other ancestor1993: 1 other ancestor2013: 1 descendant cleared2009: 1 descendant cleared2011: 1 descendant clearedK870864 · Culturette Brand CDT Clostridium Difficile Test · Marion Laboratories, Inc. · 19871990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors 1 generation forward: 3 descendants K870864 · Culturette Brand CDT Clostridium Difficile Test · Marion Laboratories, Inc. · 19870
  1. Root · 1 generation backK870864 Culturette Brand CDT Clostridium Difficile TestMarion Laboratories, Inc. · 1987
  2. This deviceK053572 C. Diff Quik ChekTechlab, Inc. · 2006
  3. Descendant · cites it directly · 0 of its ownK132010 Vidas C Difficile GDHBiomerieux S.A. · 2013
  4. Descendant · cites it directly · 0 of its ownK112048 Immunocard C. Difficile GDHMeridian Bioscience, Inc. · 2011
  5. Descendant · cites it directly · 0 of its ownK082499 C. Diff Quik Chek CompleteTechlab, Inc. · 2009

Most influential descendants

Showing 3 of 3 · See all
  • K132010Vidas C Difficile GDHBiomerieux S.A. · 2013 · cites it directly0descendants
  • K112048Immunocard C. Difficile GDHMeridian Bioscience, Inc. · 2011 · cites it directly0descendants
  • K082499C. Diff Quik Chek CompleteTechlab, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K870864Culturette Brand CDT Clostridium Difficile TestMarion Laboratories, Inc.1987—
0 (this device)K053572C. Diff Quik ChekTechlab, Inc.2006—
+1K132010Vidas C Difficile GDHBiomerieux S.A.2013—
+1K112048Immunocard C. Difficile GDHMeridian Bioscience, Inc.2011—
+1K082499C. Diff Quik Chek CompleteTechlab, Inc.2009—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199310
199810
200320

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201110
201310
FIG. 1 — Lineage of K053572, 1987–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 MCB? 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
Get a 510(k) Report

What was it cleared against? (6)

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
*K030992C. Diff Chek - 60
Summary page 1
…C. difficile Culture media such as cycloserine - cefoxitin fructose agar (CCFA) is available commercially from various sources. * C. DIFFCHEKIm - 60 (K03 0992) - TECHLAB®, Inc. (Blacksburg, VA) * C. DIFFCHEKYm- 30 (K03099 1) - TEcHLAB®, Inc. (Blacksburg, VA) * BD CULTUR…
Techlab, Inc.2003—
*K030991C. Diff Chek - 30
Summary page 1
…CCFA) is available commercially from various sources. * C. DIFFCHEKIm - 60 (K03 0992) - TECHLAB®, Inc. (Blacksburg, VA) * C. DIFFCHEKYm- 30 (K03099 1) - TEcHLAB®, Inc. (Blacksburg, VA) * BD CULTURETTETM CDTTM (K870864) - Becton, Dickinson and Company (Frankli…
Techlab, Inc.2003—
*K870864Culturette Brand CDT Clostridium Difficile Test
Summary page 1
…DIFFCHEKIm - 60 (K03 0992) - TECHLAB®, Inc. (Blacksburg, VA) * C. DIFFCHEKYm- 30 (K03099 1) - TEcHLAB®, Inc. (Blacksburg, VA) * BD CULTURETTETM CDTTM (K870864) - Becton, Dickinson and Company (Franklin Lakes, NJ) * Triage®)Micro Clostridiumn difficile Panel (K974881)…
Marion Laboratories, Inc.1987—
*K974881Triage C. Difficile, Triage C. Difficile Panel, Triage C. Difficile Toxin a
Summary page 1
…rg, VA) * BD CULTURETTETM CDTTM (K870864) - Becton, Dickinson and Company (Franklin Lakes, NJ) * Triage®)Micro Clostridiumn difficile Panel (K974881) - Biosite Incorporated (San Diego, CA) * InmmuoCardo C. difficile FIA (K924979) - Meridian Bioscience, Inc.…
Biosite Incorporated19981
*K924979Immunocard (TM) C. Difficile
Summary page 1
…lin Lakes, NJ) * Triage®)Micro Clostridiumn difficile Panel (K974881) - Biosite Incorporated (San Diego, CA) * InmmuoCardo C. difficile FIA (K924979) - Meridian Bioscience, Inc. (Cincinnati, OH) Inlended Use *The C. DIFFQUIK CHEKTM test is a rapid membrane e…
Meridian Diagnostics, Inc.1993—
*—C. difficile Presumptive bacterial culture
Named without a submission number
—

Also cleared against K030992: 2 other devices →

What descends from it? (3)

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

NumberDeviceApplicantDecidedDescendants
K132010Vidas C Difficile GDHBiomerieux S.A.20130
K112048Immunocard C. Difficile GDHMeridian Bioscience, Inc.20110
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?

  • 1 of the 5 ancestors has a recall of any class.
  • Of its descendants, K132010 (Biomerieux S.A., 2013) has gone furthest, with 0 descendants of its own.
  • 2 other devices also cite its predicate K030992.

How does its category compare?

All MCB devices

MCB Antigen, C. Difficile: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MCB

1in 2013

2011: 22013: 1
2007high 2 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MCB

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

Recalls per year · MCB

1in 2021

2007: 12021: 1
2007high 1 (2007) · low 0 (2008)2026

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

Adverse event reports per year · MCB

2in 2023

2018: 32021: 22022: 22023: 2
2007high 3 (2018) · low 0 (2007)2025

MAUDE reports naming product code MCB, 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—10
20080—00
20090—00
20100—00
20112—00
20120—00
20131—00
20140—00
20150—00
20160—00
20170—00
20180—03
20190—00
20200—00
20210—12
20220—02
20230—02
20240—00
20250—00
20260—0—

What is it indicated for?

The C. DIFF QUIK CHEK™ test is a rapid membrane enzyme immunoassay for use as a screening test to detect Clostridium difficile antigen, glutamate dehydrogenase, in fecal specimens from persons suspected of having C. difficile disease. The test does not distinguish toxigenic from nontoxigenic strains of C. difficile. With the use of additional tests that detect C. difficile toxins, 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K030992

2 other devices cite the same predicate.

  • K110620Premier C. Difficile GDHMeridian Bioscience, Inc. · 2011
  • K082499C. Diff Quik Chek CompleteTechlab, Inc. · 2009

More from Techlab, Inc.

36 FDA decisions under this applicant name. See the company

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

Recent decisions in MCB

The MCB category page

  • K132010Vidas C Difficile GDHBiomerieux S.A. · 2013
  • K112048Immunocard C. Difficile GDHMeridian Bioscience, Inc. · 2011
  • K110620Premier C. Difficile GDHMeridian Bioscience, Inc. · 2011
  • K974881Triage C. Difficile, Triage C. Difficile Panel, Triage C. Difficile Toxin aBiosite Incorporated · 19981 recall
  • K955067Clearview C. Diff aUnipath, Ltd. · 1996

https://510kreport.com/device/K053572 · printed Nov 4, 2026

Cite this page

510(k) Report. “K053572: C. Diff Quik Chek.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K053572

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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