# K100818: Illumigene C. Difficile, Illumipro-10 and Illumigene C. Difficile External Control Kit, Models 280050, 610172, 279920

- Pathway: 510(k) (Traditional)
- Applicant: Meridian Bioscience, Inc.
- Decided: Jul 9, 2010 after 108 days
- Product code: OMN (C. Difficile Nucleic Acid Amplification Test Assay)
- Device class: 1
- Regulation: 21 CFR 866.2660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K923463 (1993). 4 ancestors in all.
2 later devices descend 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)
- K091109: Xpert C. Difficile, Cepheid (2009) Summary page 1.

## Most influential descendants
- K110012: Illumigene C. Difficile, and Illumipro-10 (2011), 1 descendant of its own
- K113433: Simplexa C. Difficile Universal Direct (2012), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K100818
Methodology: https://510kreport.com/methodology