510(k) · Cleared
ClearedXpert C. Difficile
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cepheid · LLH Reagents, Clostridium Difficile Toxin
Cleared on Jul 9, 2009 as substantially equivalent to K081920 (Bd Diagnostics (Geneohm Sciences, Inc.), 2008) after an 84-day review. Its family tree reaches back 2 generations to 1993. 5 later devices descend from it.
- Decided
- Jul 9, 2009
- Review
- 84 days
- Class
- Class I
- Product code
- LLH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K923463 (1993). 3 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK923463 Clostridium Difficile Toxin/Antitoxin KitTechlab, Inc. · 1993
- 1 generation backK081920 BD Geneohm Cdiff AssayBd Diagnostics (Geneohm Sciences, Inc.) · 2008 · Recalled
- This deviceK091109 Xpert C. DifficileCepheid · 2009
- Descendant · cites it directly · 2 of its ownK100818 Illumigene C. Difficile, Illumipro-10 and Illumigene C. Difficile…Meridian Bioscience, Inc. · 2010
- Descendant · cites it directly · 1 of its ownK110203 Xpert C. Difficle/Epi AssayCepheid · 2011
- Descendant · 2 generations on · 1 of its ownK110012 Illumigene C. Difficile, and Illumipro-10Meridian Bioscience, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 0 of its ownK123197 Verigene C. Difficile Nucleic Acid Test (CDF)Nanosphere, Inc. · 2012 · Recalled
- Descendant · 3 generations on · 0 of its ownK113433 Simplexa C. Difficile Universal DirectFocus Diagnostics, Inc. · 2012
Most influential descendants
Showing 5 of 5 · See all- K100818Illumigene C. Difficile, Illumipro-10 and Illumigene C. Difficile External Control Kit…Meridian Bioscience, Inc. · 2010 · cites it directly2descendants
- K110203Xpert C. Difficle/Epi AssayCepheid · 2011 · cites it directly1descendant
- K110012Illumigene C. Difficile, and Illumipro-10Meridian Bioscience, Inc. · 2011 · 2 generations on1descendant
- K123197Verigene C. Difficile Nucleic Acid Test (CDF)Nanosphere, Inc. · 2012 · 2 generations on0descendants
- K113433Simplexa C. Difficile Universal DirectFocus Diagnostics, Inc. · 2012 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K923463 | Clostridium Difficile Toxin/Antitoxin Kit | Techlab, Inc. | 1993 | — |
| −1 | K081920 | BD Geneohm Cdiff Assay | Bd Diagnostics (Geneohm Sciences, Inc.) | 2008 | 4 |
| 0 (this device) | K091109 | Xpert C. Difficile | Cepheid | 2009 | — |
| +1 | K100818 | Illumigene C. Difficile, Illumipro-10 and Illumigene C. Difficile External… | Meridian Bioscience, Inc. | 2010 | — |
| +1 | K110203 | Xpert C. Difficle/Epi Assay | Cepheid | 2011 | — |
| +2 | K110012 | Illumigene C. Difficile, and Illumipro-10 | Meridian Bioscience, Inc. | 2011 | 2 |
| +2 | K123197 | Verigene C. Difficile Nucleic Acid Test (CDF) | Nanosphere, Inc. | 2012 | 4 |
| +3 | K113433 | Simplexa C. Difficile Universal Direct | Focus Diagnostics, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 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? (2)
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 |
|---|---|---|---|
| * | K081920 | BD Geneohm Cdiff AssaySummary page 1…LLH Classification Advisory Microbiology Committee: Panel: 83 Predicate Device: BD GeneOhm TM Cdiff Assay [510(k) # K081920] Device Description: The Cepheid Xpert C. difficile Assay is a-rapid, automated in vitro diagnostic test for qualitative… | 2008 |
| * | — | C. difficile reference culture method followed with strain identification of all C.… Named without a submission number |
What descends from it? (5)
2 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?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 15.9 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K100818 (Meridian Bioscience, Inc., 2010) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K081920.
How does its category compare?
All LLH devicesLLH Reagents, Clostridium Difficile Toxin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
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?
The Cepheid Xpert® C. difficile Assay, performed on the Cepheid GeneXpert® Dx System, is a qualitative in vitro diagnostic test for rapid detection of toxin B gene sequences from unformed (liquid or soft) stool specimens collected from patients suspected of having Clostridium difficile infection (CDI). The test utilizes automated real-time polymerase chain reaction (PCR) to detect toxin gene sequences associated with toxin producing C. difficile. The Xpert C. difficile Assay is intended as an aid in the diagnosis of CDI. Concomitant culture is necessary only if further typing or organism recovery is required.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091109 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091109: Xpert C. Difficile.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091109
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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