510(k) · Cleared
ClearedC. Difficile Toxin a + B Fecal Antigen Detection Microwell Elisa Kit Model; Cdiff-96
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ivd Research, Inc. · LLH Reagents, Clostridium Difficile Toxin
Cleared on May 27, 2004 after a 253-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- May 27, 2004
- Review
- 253 days
- Class
- Class I
- Product code
- LLH
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
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
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
How does its category compare?
All LLH devicesLLH Reagents, Clostridium Difficile Toxin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LLH
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · LLH
84in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLH
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLH
1in 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?
This microwell enzyme-linked immunoabsorbant assay (ELISA) detection kit (C. difficile Toxin A+B ELISA Kit) is an in vitro diagnostic (IVD) immunoassay intended for use as an aid in the diagnosis of C. difficile associated disease. The kit detects C. difficile toxin A and B in human feces using peroxidase as the indicator enzyme. The assay may be read visually or with an ELISA reader. This IVD C. difficile Toxin A+B ELISA Kit is intended to be used with human stools that are fresh, frozen or in Cary Blair transport media in a clinical laboratory use setting. The kit may also be used with IVD Research's Quick'N'Easy fecal dilution device.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K032897 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032897: C. Difficile Toxin a + B Fecal Antigen Detection Microwell Elisa Kit Model; Cdiff-96.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032897
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026