510(k) · Cleared

Cleared

Prospect Clostridium Difficile Toxin a/B Microplate Assay

K033479510(k) TraditionalCleared Feb 26, 2004115-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

Remel, Inc. · LLH Reagents, Clostridium Difficile Toxin

Cleared on Feb 26, 2004 as substantially equivalent to K993914 (Meridian Diagnostics, Inc., 1999) and 2 other predicates after a 115-day review. Its family tree reaches back 2 generations to 1991. 2 later devices descend from it.

Decided: Feb 26, 2004
Review: 115 days
Class: Class I
Product code: LLH
Recalls: None
Predicates: 3

Its longest line of descent runs back 2 generations to K911958 (1991). 4 ancestors in all. 2 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 2 generations backK911958 Cytoclone a & B EiaCambridge Biotech Corp. · 1991
1 generation backK993914 Premier Toxins a&B, Model 616096Meridian Diagnostics, Inc. · 1999 · Recalled
This deviceK033479 Prospect Clostridium Difficile Toxin a/B Microplate AssayRemel, Inc. · 2004
Descendant · cites it directly · 1 of its ownK050891 Tox a/B Quick ChekTechlab, Inc. · 2005
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

Generation	Number	Device	Applicant	Decided	Recalls
−2	K911958	Cytoclone a & B Eia	Cambridge Biotech Corp.	1991	—
−1	K993914	Premier Toxins a&B, Model 616096	Meridian Diagnostics, Inc.	1999	2
0 (this device)	K033479	Prospect Clostridium Difficile Toxin a/B Microplate Assay	Remel, Inc.	2004	—
+1	K050891	Tox a/B Quick Chek	Techlab, Inc.	2005	—
+1	K082499	C. Diff Quik Chek Complete	Techlab, Inc.	2009	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
2000	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2009	1	0

FIG. 1 — Lineage of K033479, 1991–2009Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 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.

Type	Number	Device	Applicant	Decided	Recalls
*	K993914	Premier Toxins a&B, Model 616096 Summary page 1 …Classification: 866.2660 Reagents, Clostridium difficile toxin, Class I, LLH D. Predicate Devices Meridian Premier Toxins A&B: 510(k) K993914 Wampole C. difficile TOX A/B II: 510(k) K003306/K971182 E. Device Description The ProSpec-T-® Clostridi…	Meridian Diagnostics, Inc.	1999	2
*	K003306	C. Difficile Tox a/B II Summary page 1 …toxin, Class I, LLH D. Predicate Devices Meridian Premier Toxins A&B: 510(k) K993914 Wampole C. difficile TOX A/B II: 510(k) K003306/K971182 E. Device Description The ProSpec-T-® Clostridium difficile Toxin A/B test detects the presence of Toxin A…	Techlab, Inc.	2000	—
*	K971182	Tox a/B Test Summary page 1 …Class I, LLH D. Predicate Devices Meridian Premier Toxins A&B: 510(k) K993914 Wampole C. difficile TOX A/B II: 510(k) K003306/K971182 E. Device Description The ProSpec-T-® Clostridium difficile Toxin A/B test detects the presence of Toxin A and Toxi…	Techlab, Inc.	1997	—

Also cleared against K993914: 2 other devices →

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K050891	Tox a/B Quick Chek	Techlab, Inc.	2005	1
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?

The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 8.4 years on median.
1 of the 4 ancestors has a recall of any class.
Of its descendants, K050891 (Techlab, Inc., 2005) has gone furthest, with 1 descendant of its own.
2 other devices also cite its predicate K993914.

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?

Remel's ProSpecT® Clostridium difficile Toxin A/B Microplate Assay is a qualitative enzyme immunoassay (EIA) for the detection of C. difficile Toxin A and B in human fecal specimens from patients suspected of having Clostridium difficile disease. The test is intended for use as an aid in diagnosis of Clostridium difficile-associated disease (CDAD).

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K033479 · printed Nov 3, 2026

Cite this page

510(k) Report. “K033479: Prospect Clostridium Difficile Toxin a/B Microplate Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033479

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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