510(k) · Cleared
ClearedXpert C. difficile/Epi
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cepheid® · OZN C. Difficile Toxin Gene Amplification Assay
Cleared on Feb 28, 2025 as substantially equivalent to K212427 (Roche Molecular Systems, Inc., 2021) after an 87-day review. Its family tree reaches back 6 generations to 1993.
- Decided
- Feb 28, 2025
- Review
- 87 days
- Class
- Class II
- Product code
- OZN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K923463 (1993). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK923463 Clostridium Difficile Toxin/Antitoxin KitTechlab, Inc. · 1993
- 5 generations backK081920 BD Geneohm Cdiff AssayBd Diagnostics (Geneohm Sciences, Inc.) · 2008 · Recalled
- 4 generations backK130470 BD Max Cdiff Assay, BD Max InstrumentGeneohm Sciences Canada, Inc. (Bd Diagnostics) · 2013 · Recalled
- 3 generations backK142422 cobas Cdiff TestRoche Molecular Systems, Inc. · 2015
- 2 generations backK171770 cobas Cdiff Nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, Inc. · 2017
- 1 generation backK212427 cobas Cdiff nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, Inc. · 2021
- This deviceK243730 Xpert C. difficile/EpiCepheid® · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K923463 | Clostridium Difficile Toxin/Antitoxin Kit | Techlab, Inc. | 1993 | — |
| −5 | K081920 | BD Geneohm Cdiff Assay | Bd Diagnostics (Geneohm Sciences, Inc.) | 2008 | 4 |
| −4 | 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 | K171770 | cobas Cdiff Nucleic acid test for use on the cobas Liat System | Roche Molecular Systems, Inc. | 2017 | — |
| −1 | K212427 | cobas Cdiff nucleic acid test for use on the cobas Liat System | Roche Molecular Systems, Inc. | 2021 | — |
| 0 (this device) | K243730 | Xpert C. difficile/Epi | Cepheid® | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 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 OZN? 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 OZN device
- #1 K260045 cobas® Cdiff Nucleic acid test for use on the…score 13.4 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 |
|---|---|---|---|
| * | K212427 | cobas Cdiff nucleic acid test for use on the cobas Liat SystemSummary page 6…Panel: Prescription Use: Yes Predicate Device: cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System (K212427) 1.1 Device Description The Xpert C. difficile/Epi test is an automated in vitro diagnostic test for qualitative detection… | 2021 |
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.
What does this lineage say?
- The line of descent spans 32 years and passes through 5 companies; a new generation was cleared every 4.1 years on median.
- 2 of the 7 ancestors have a recall of any class.
- 1 other device also cites its predicate K212427.
How does its category compare?
All OZN devicesOZN C. Difficile Toxin Gene Amplification Assay: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · OZN
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OZN
89in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OZN
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OZN
3in 2025
MAUDE reports naming product code OZN, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 4 | 79 | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 5 | 89 | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 1 | — | 0 | 2 |
| 2024 | 0 | — | 1 | 7 |
| 2025 | 1 | — | 2 | 3 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Xpert® C. difficile/Epi test is a qualitative in vitro diagnostic test for detection of toxin B gene sequences and for presumptive identification of 027/NAP1/BI strains of toxigenic Clostridioides difficile from unformed (liquid or soft) stool specimens collected from patients suspected of having C. difficile infection (CDI). Presumptive identification of 027/NAP1/BI strains of C. difficile is by detection of binary toxin (CDT) gene sequences and the…
Read the full statement (180 words)
The Xpert® C. difficile/Epi test is a qualitative in vitro diagnostic test for detection of toxin B gene sequences and for presumptive identification of 027/NAP1/BI strains of toxigenic Clostridioides difficile from unformed (liquid or soft) stool specimens collected from patients suspected of having C. difficile infection (CDI). Presumptive identification of 027/NAP1/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 tcdC gene. The tcdC gene encodes for a negative regulator in C. difficile toxin production. The test is performed on the GeneXpert® Instrument Systems 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 test is intended as an aid in the diagnosis of CDI. Detection of 027/NAP1/BI strains of C. difficile by the Xpert C. difficile/Epi test 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/K243730 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243730: Xpert C. difficile/Epi.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243730
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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