510(k) · Cleared
ClearedIllumigene C. Difficile, Illumipro-10 and Illumigene C. Difficile External Control Kit, Models 280050, 610172, 279920
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 Jul 9, 2010 as substantially equivalent to K091109 (Cepheid, 2009) after a 108-day review. Its family tree reaches back 3 generations to 1993. 2 later devices descend from it.
- Decided
- Jul 9, 2010
- Review
- 108 days
- Class
- Class I
- Product code
- OMN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K923463 (1993). 4 ancestors in all. 2 later devices descend 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 deviceK100818 Illumigene C. Difficile, Illumipro-10 and Illumigene C. Difficile…Meridian Bioscience, Inc. · 2010
- Descendant · cites it directly · 1 of its ownK110012 Illumigene C. Difficile, and Illumipro-10Meridian Bioscience, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 0 of its ownK113433 Simplexa C. Difficile Universal DirectFocus Diagnostics, Inc. · 2012
Most influential descendants
Showing 2 of 2 · See allView 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) | K100818 | Illumigene C. Difficile, Illumipro-10 and Illumigene C. Difficile External… | Meridian Bioscience, Inc. | 2010 | — |
| +1 | K110012 | Illumigene C. Difficile, and Illumipro-10 | Meridian Bioscience, Inc. | 2011 | 2 |
| +2 | 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 |
|---|---|---|
| 2011 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K091109 | Xpert C. DifficileSummary page 1…ification Assay Classification name: C. dufficile Nucleic Acids OMN, CFR Section 866.2660 Predicate device: K091 109: Cepheid® Xpert®)C. difficile Model GXVDIFFICILE-10,900-0423, 900-0065, 900-0144, 900-0145, 900-… | 2009 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110012 | Illumigene C. Difficile, and Illumipro-10 | 2011 | 1 |
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 17 years and passes through 4 companies; a new generation was cleared every 12 months on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K110012 (Meridian Bioscience, Inc., 2011) has gone furthest, with 1 descendant 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. 2010, 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-10, is a qualitative in vitro diagnostic test for the direct detection of toxigenic C. difjicile in human stool specimens from patients suspected of having Clostridiuni 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 Clostridiurn…
Read the full statement (170 words)
The illumigene C.difficile DNA amplification assay, performed on the illumipro-10, is a qualitative in vitro diagnostic test for the direct detection of toxigenic C. difjicile in human stool specimens from patients suspected of having Clostridiuni 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 Clostridiurn difficile. The Clostridiuni difficile PaLoc is a gene segment present in all known toxigenic C.difficile strains. The C.difficile Patoc codes for both the Toxin A gene (tcdA) and the Toxin Bgene (tcdfi), has conserved border regions, and is found at the same site on the C.difficile genome for all toxigenic strains . The illurmigene 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.
illumnigene 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/K100818 · printed Nov 5, 2026
Cite this page
510(k) Report. “K100818: Illumigene C. Difficile, Illumipro-10 and Illumigene C. Difficile External Control Kit, Models 280050, 610172, 279920.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K100818
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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