510(k) · Cleared
ClearedXpert C. Difficle/Epi Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cepheid · OMN C. Difficile Nucleic Acid Amplification Test Assay
Cleared on Apr 7, 2011 as substantially equivalent to K091109 (Cepheid, 2009) and 1 other predicate after a 73-day review. Its family tree reaches back 3 generations to 1993. 1 later device descends from it.
- Decided
- Apr 7, 2011
- Review
- 73 days
- Class
- Class I
- Product code
- OMN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K923463 (1993). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK923463 Clostridium Difficile Toxin/Antitoxin KitTechlab, Inc. · 1993
- 2 generations backK081920 BD Geneohm Cdiff AssayBd Diagnostics (Geneohm Sciences, Inc.) · 2008 · Recalled
- 1 generation backK091109 Xpert C. DifficileCepheid · 2009
- This deviceK110203 Xpert C. Difficle/Epi AssayCepheid · 2011
- Descendant · cites it directly · 0 of its ownK123197 Verigene C. Difficile Nucleic Acid Test (CDF)Nanosphere, Inc. · 2012 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K123197Verigene C. Difficile Nucleic Acid Test (CDF)Nanosphere, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K923463 | Clostridium Difficile Toxin/Antitoxin Kit | Techlab, Inc. | 1993 | — |
| −2 | K081920 | BD Geneohm Cdiff Assay | Bd Diagnostics (Geneohm Sciences, Inc.) | 2008 | 4 |
| −1 | K091109 | Xpert C. Difficile | Cepheid | 2009 | — |
| 0 (this device) | K110203 | Xpert C. Difficle/Epi Assay | Cepheid | 2011 | — |
| +1 | K123197 | Verigene C. Difficile Nucleic Acid Test (CDF) | Nanosphere, Inc. | 2012 | 4 |
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 |
|---|---|---|
| 2012 | 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 OMN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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 |
|---|---|---|---|
| * | K091109 | Xpert C. Difficile Our reading of the summary gave K001109, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Cepheid Xpert C. difficile Assay”. | 2009 |
| * | K081920 | BD Geneohm Cdiff AssaySummary page 4…Assay (K(091109) (diff Assay - (K081920) Intended The Cepheid Xpert® C. The Cepheid Xpert C. The BD Gene~hmn Use difficile/Epi… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123197 | Verigene C. Difficile Nucleic Acid Test (CDF) | 2012 | 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 18 years and passes through 3 companies; a new generation was cleared every 1.7 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K123197 (Nanosphere, Inc., 2012) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K091109.
How does its category compare?
All OMN devicesOMN C. Difficile Nucleic Acid Amplification Test Assay: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · OMN
1in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · OMN
Too few OMN 510(k)s in any year since 2007 to give a median.
Recalls per year · OMN
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OMN
No MAUDE report names OMN since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 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 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 1 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Cepheid Xpert® C. difficile/Epi Assay is a qualitative in vitro diagnostic test for rapid detection of toxin B gene sequences and for presumptive identification of 027/NAP 1/131 strains of toxigenic Clostridium dificile from unformed (liquid or soft) stool specimens collected from patients suspected of having C. cifficile infection (CDI). Presumptive identification of 027/NAPI/BI strains of C. difficile is by detection of binary toxin (CDT) gene…
Read the full statement (185 words)
The Cepheid Xpert® C. difficile/Epi Assay is a qualitative in vitro diagnostic test for
rapid detection of toxin B gene sequences and for presumptive identification of
027/NAP 1/131 strains of toxigenic Clostridium dificile from unformed (liquid or soft)
stool specimens collected from patients suspected of having C. cifficile infection (CDI).
Presumptive identification of 027/NAPI/BI strains of C. difficile is by detection of binary
toxin (CDT) gene sequences and the single base pair deletion at nucleotide 117 in the
tedC gene. The tcdC gene encodes for a negative regulator in C. difficile toxin
production. The test is performed on the Cepheid GeneXpertV Dx System and utilizes
automated real-time polymerase chain reaction (PCR) to detect toxin gene sequences
associated with toxin producing C. difficile. The Xpert C. difficile/Epi Assay is intended
as an aid in the diagnosis of CDI. Detection of 027/NAP]I fBl strains of C. difficile by the
Xpert C. dificile/Epi Assay is presumptive and is solely for epidemiological purposes
and is not intended to guide or monitor treatment for C. difficile infections. 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/K110203 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110203: Xpert C. Difficle/Epi Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110203
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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