510(k) · Cleared
ClearedXpect Clostridium Difficile Toxin a/B
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Remel, Inc. · LLH Reagents, Clostridium Difficile Toxin
Cleared on Nov 15, 2004 after a 118-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Nov 15, 2004
- Review
- 118 days
- Class
- Class I
- Product code
- LLH
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 3 citing it directly.
- This deviceK041951 Xpect Clostridium Difficile Toxin a/BRemel, Inc. · 2004
- Descendant · cites it directly · 1 of its ownK050891 Tox a/B Quick ChekTechlab, Inc. · 2005
- Descendant · cites it directly · 0 of its ownK102242 Osom C. Difficile Toxin a/B TestGenzyme Corporation · 2010 · Recalled
- Descendant · cites it directly · 0 of its ownK082499 C. Diff Quik Chek CompleteTechlab, Inc. · 2009
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K041951 | Xpect Clostridium Difficile Toxin a/B | Remel, Inc. | 2004 | — |
| +1 | K050891 | Tox a/B Quick Chek | Techlab, Inc. | 2005 | — |
| +1 | K102242 | Osom C. Difficile Toxin a/B Test | Genzyme Corporation | 2010 | 1 |
| +1 | K082499 | C. Diff Quik Chek Complete | Techlab, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
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
What was it cleared against? (1)
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 | Decided |
|---|---|---|---|
| * | — | BD ColorPAC Toxin A Named without a submission number |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K050891 (Techlab, Inc., 2005) has gone furthest, with 1 descendant of its own.
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?
REMEL's Xpect TM Clostridium difficile Toxin A/B is a rapid in vitro immunochromatographic test for the direct, qualitative detection of Clostridium difficile Toxin A and/or B in human fecal specimens from patients suspected of having Clostridium difficile-associated disease (ODAD). The test is intended for use as an aid in diagnosis of CDAD. The test can also be used for confirmation of toxigenic Clostridium difficile from Brain Heart Infusion (BHI) broth culture.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041951 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041951: Xpect Clostridium Difficile Toxin a/B.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041951
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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