510(k) · Cleared
ClearedClostridium Difficile Tox-B Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Techlab, Inc. · LLH Reagents, Clostridium Difficile Toxin
Cleared on Apr 26, 1994 after a 174-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 21 later devices descend from it.
- Decided
- Apr 26, 1994
- Review
- 174 days
- Class
- Class I
- Product code
- LLH
- Recalls
- None
- Predicates
- 0
21 later devices descend from it, 3 citing it directly.
- This deviceK935296 Clostridium Difficile Tox-B TestTechlab, Inc. · 1994
- Descendant · cites it directly · 18 of its ownK081920 BD Geneohm Cdiff AssayBd Diagnostics (Geneohm Sciences, Inc.) · 2008 · Recalled
- Descendant · 2 generations on · 10 of its ownK130470 BD Max Cdiff Assay, BD Max InstrumentGeneohm Sciences Canada, Inc. (Bd Diagnostics) · 2013 · Recalled
- Descendant · 3 generations on · 5 of its ownK142422 cobas Cdiff TestRoche Molecular Systems, Inc. · 2015
- Descendant · 2 generations on · 5 of its ownK091109 Xpert C. DifficileCepheid · 2009
- Descendant · 4 generations on · 4 of its ownK171770 cobas Cdiff Nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, Inc. · 2017
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K081920BD Geneohm Cdiff AssayBd Diagnostics (Geneohm Sciences, Inc.) · 2008 · cites it directly18descendants
- K130470BD Max Cdiff Assay, BD Max InstrumentGeneohm Sciences Canada, Inc. (Bd Diagnostics) · 2013 · 2 generations on10descendants
- K142422cobas Cdiff TestRoche Molecular Systems, Inc. · 2015 · 3 generations on5descendants
- K091109Xpert C. DifficileCepheid · 2009 · 2 generations on5descendants
- K171770cobas Cdiff Nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, Inc. · 2017 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K935296 | Clostridium Difficile Tox-B Test | Techlab, Inc. | 1994 | — |
| +1 | K081920 | BD Geneohm Cdiff Assay | Bd Diagnostics (Geneohm Sciences, Inc.) | 2008 | 4 |
| +2 | K130470 | BD Max Cdiff Assay, BD Max Instrument | Geneohm Sciences Canada, Inc. (Bd Diagnostics) | 2013 | 2 |
| +3 | K142422 | cobas Cdiff Test | Roche Molecular Systems, Inc. | 2015 | — |
| +2 | K091109 | Xpert C. Difficile | Cepheid | 2009 | — |
| +4 | K171770 | cobas Cdiff Nucleic acid test for use on the cobas Liat System | Roche Molecular Systems, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 3 | 0 |
| 2021 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (21)
See all 213 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, K081920 (Bd Diagnostics (Geneohm Sciences, Inc.), 2008) has gone furthest, with 18 descendants 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 | — |
https://510kreport.com/device/K935296 · printed Nov 4, 2026
Cite this page
510(k) Report. “K935296: Clostridium Difficile Tox-B Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K935296
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026