# K110012: Illumigene C. Difficile, and Illumipro-10

- Pathway: 510(k) (Traditional)
- Applicant: Meridian Bioscience, Inc.
- Decided: Feb 24, 2011 after 52 days
- Product code: OMN (C. Difficile Nucleic Acid Amplification Test Assay)
- Device class: 1
- Regulation: 21 CFR 866.2660
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K923463 (1993). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100818: Illumigene C. Difficile, Illumipro-10 and Illumigene C. Difficile External Control Kit, Models 280050, 610172, 279920, Meridian Bioscience, Inc. (2010) Summary page 1.

## Most influential descendants
- K113433: Simplexa C. Difficile Universal Direct (2012), 0 descendants of its own

## Recalls of this device
- Oct 7, 2025 · Class II · Z-0568-2026: 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: Illumipro-10 instruments may have Block B chambers operating at an incorrect temperature as a result of incorrect temperature calibration.

## Indications for use
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.

Source page: https://510kreport.com/device/K110012
Methodology: https://510kreport.com/methodology