510(k) · Cleared
Recalled · Class II · 2025Illumigene C. Difficile, and Illumipro-10
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Meridian Bioscience, Inc. · OMN C. Difficile Nucleic Acid Amplification Test Assay
Cleared on Feb 24, 2011 as substantially equivalent to K100818 (Meridian Bioscience, Inc., 2010) after a 52-day review. Its family tree reaches back 4 generations to 1993. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Feb 24, 2011
- Review
- 52 days
- Class
- Class I
- Product code
- OMN
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 4 generations to K923463 (1993). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK923463 Clostridium Difficile Toxin/Antitoxin KitTechlab, Inc. · 1993
- 3 generations backK081920 BD Geneohm Cdiff AssayBd Diagnostics (Geneohm Sciences, Inc.) · 2008 · Recalled
- 2 generations backK091109 Xpert C. DifficileCepheid · 2009
- 1 generation backK100818 Illumigene C. Difficile, Illumipro-10 and Illumigene C. Difficile…Meridian Bioscience, Inc. · 2010
- This deviceK110012 Illumigene C. Difficile, and Illumipro-10Meridian Bioscience, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK113433 Simplexa C. Difficile Universal DirectFocus Diagnostics, Inc. · 2012
Most influential descendants
Showing 1 of 1 · See all- K113433Simplexa C. Difficile Universal DirectFocus Diagnostics, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K923463 | Clostridium Difficile Toxin/Antitoxin Kit | Techlab, Inc. | 1993 | — |
| −3 | K081920 | BD Geneohm Cdiff Assay | Bd Diagnostics (Geneohm Sciences, Inc.) | 2008 | 4 |
| −2 | K091109 | Xpert C. Difficile | Cepheid | 2009 | — |
| −1 | K100818 | Illumigene C. Difficile, Illumipro-10 and Illumigene C. Difficile External… | Meridian Bioscience, Inc. | 2010 | — |
| 0 (this device) | K110012 | Illumigene C. Difficile, and Illumipro-10 | Meridian Bioscience, Inc. | 2011 | — |
| +1 | 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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K100818 | Illumigene C. Difficile, Illumipro-10 and Illumigene C. Difficile External Control Kit…Summary page 1…ification Assay Classification name: C.difficile Nucleic Acids OMN, CIFR Section 866.2660 Predicate device: K100818: iIlumigene®Molecular Diagnostic Test System (iliumigene C.difficilfe DNA Amplification Assay, i… | 2010 |
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 |
|---|---|---|---|
| K113433 | Simplexa C. Difficile Universal Direct | 2012 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 7, 2025 | Class II | Z-0568-2026 | Nonconforming Material/Component | The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the potential for leakage and reduced buffer volume. |
| Apr 22, 2014 | Class II | Z-1941-2014 | Employee error | Illumipro-10 instruments may have Block B chambers operating at an incorrect temperature as a result of incorrect temperature calibration. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 12 months on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K113433 (Focus Diagnostics, Inc., 2012) has gone furthest, with 0 descendants of its own.
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 illumigene C. difficile DNA amplification assay, performed on the illumipro-IO, is a qualitative in vitro diagnostic test for the direct detection of toxigenic C difficile in human stool specimens from pediatric and adult patients suspected of having Clostridium difficile-associated disease (CDAD), The illumigene C difficile assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect the pathogenicity locus (PaLoc) of…
Read the full statement (175 words)
The illumigene C. difficile DNA amplification assay, performed on the illumipro-IO, is a qualitative in vitro diagnostic test for the direct detection of toxigenic C difficile in human stool specimens from pediatric and adult patients suspected of having Clostridium difficile-associated disease (CDAD),
The illumigene C difficile assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect the pathogenicity locus (PaLoc) of toxigenic Clostridium difficile. The Clostridium difficile PaLoc is a gene segment present in all known toxigenic C.difficile strains. The C.difficile PaLoc codes for both the Toxin A gene (tcdA) and the Toxin B gene (tcdB), has conserved border regions, and is found at the same site on the C difficile genome for all toxigenic strains. The illumigene C difficile assay detects the PaLoc by targeting a partial DNA fragment on the Toxin A gene. The tcdA target region was selected as an intact region remaining in all known A+B+ and A-B3+ toxinotypes.
illumigene C. difficile is intended for use in hospital, reference or state laboratory settings. The device is not intended for point-of-care use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110012 · printed Nov 3, 2026
Cite this page
510(k) Report. “K110012: Illumigene C. Difficile, and Illumipro-10.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K110012
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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