510(k) · Cleared

Cleared

C. Diff Chek - 60

K030992510(k) TraditionalCleared Jul 11, 2003105-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 11, 2003 after a 105-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 5 later devices descend from it.

Decided: Jul 11, 2003
Review: 105 days
Class: Class I
Product code: LLH
Recalls: None
Predicates: 0

5 later devices descend from it, 3 citing it directly.

This deviceK030992 C. Diff Chek - 60Techlab, Inc. · 2003
Descendant · cites it directly · 3 of its ownK053572 C. Diff Quik ChekTechlab, Inc. · 2006
Descendant · 2 generations on · 0 of its ownK132010 Vidas C Difficile GDHBiomerieux S.A. · 2013
Descendant · 2 generations on · 0 of its ownK112048 Immunocard C. Difficile GDHMeridian Bioscience, Inc. · 2011
Descendant · cites it directly · 0 of its ownK110620 Premier C. Difficile GDHMeridian Bioscience, Inc. · 2011
Descendant · cites it directly · 0 of its ownK082499 C. Diff Quik Chek CompleteTechlab, Inc. · 2009

Most influential descendants

Showing 5 of 5 · See all

K053572C. Diff Quik ChekTechlab, Inc. · 2006 · cites it directly3descendants
K132010Vidas C Difficile GDHBiomerieux S.A. · 2013 · 2 generations on0descendants
K112048Immunocard C. Difficile GDHMeridian Bioscience, Inc. · 2011 · 2 generations on0descendants
K110620Premier 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

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K030992	C. Diff Chek - 60	Techlab, Inc.	2003	—
+1	K053572	C. Diff Quik Chek	Techlab, Inc.	2006	—
+2	K132010	Vidas C Difficile GDH	Biomerieux S.A.	2013	—
+2	K112048	Immunocard C. Difficile GDH	Meridian Bioscience, Inc.	2011	—
+1	K110620	Premier C. Difficile GDH	Meridian Bioscience, Inc.	2011	—
+1	K082499	C. Diff Quik Chek Complete	Techlab, Inc.	2009	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2009	1	0
2011	2	0
2013	1	0

FIG. 1 — Lineage of K030992, 2003–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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 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’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (5)

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

Number	Device	Applicant	Decided	Descendants
K053572	C. Diff Quik Chek	Techlab, Inc.	2006	3
K110620	Premier C. Difficile GDH	Meridian Bioscience, Inc.	2011	0
K082499	C. Diff Quik Chek Complete	Techlab, Inc.	2009	0

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, K053572 (Techlab, Inc., 2006) has gone furthest, with 3 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

2007high 3 (2009) · low 0 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LLH

84in 2009

2007high 84 (2009)2026

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

Recalls per year · LLH

1in 2021

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	1	—	0	0
2008	2	—	0	0
2009	3	84	0	0
2010	1	—	1	1
2011	0	—	0	0
2012	0	—	2	0
2013	0	—	2	0
2014	0	—	0	0
2015	0	—	0	0
2016	0	—	0	0
2017	0	—	0	0
2018	0	—	0	0
2019	0	—	0	0
2020	0	—	0	0
2021	1	—	1	1
2022	0	—	0	1
2023	0	—	0	1
2024	0	—	0	1
2025	0	—	0	1
2026	0	—	0	—

What is it indicated for?

The C. DIFF CHEK™-60 test is an 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 non toxigenic 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. FOR IN VITRO DIAGNOSTIC USE.

Indications for use as stated in the FDA 510(k) statement.

https://510kreport.com/device/K030992 · printed Nov 3, 2026

Cite this page

510(k) Report. “K030992: C. Diff Chek - 60.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K030992

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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