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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. 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 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-B+ 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.

The illumigene Molecular Diagnostic Test System is comprised of the illumigene C. difficile DNA Amplification Test Kit, the illumigene C. difficile External Control Kit and the illumipro-10 Automated Isothermal Amplification and Detection System. The illumigene C. difficile DNA amplification assay utilizes loop-mediated isothermal amolification (LAMP) technology to detect the presence of toxigenic C. difficile in patients suspected of having C. difficile associated disease (CDAD). Each illumigene C. difficile assay is completed using an illumigene Sample Preparation Apparatus. Illumigene Reaction Buffer, illumigene C. difficile Test Device, Sample Collection Brush, and illumigene Extraction Tube. Samples are prepared using the Sample Collection Brush and the illumigene Sample Collection Apparatus, target DNA is heat extracted in the Extraction Tube and DNA amplification occurs in the illumigene C. difficile Test Device.

The illumipro-10 heats each illumigene C. difficile Test Device containing prepared samples, facilitation of target DNA. When toxigenic C. difficile is present in the patient specific sequence is amplified and Magnesium pyrophosphate is formed. Magnesium pyrophosphate in the reaction mixture. The illumipro-10 detects the change in light transmission mixture created by the precipitating Magnesium pyrophosphate. Sample results are reported as Positive based on the detected change in transmission.

The illumigene C. difficile External Control Kit consists of a Positive Control Reagent. External Control reagents are provided to aid the user in detection of reagent deterioration, adverse environmental or test conditions, or variance in operator performance that may lead to test errors. The illumigene C. difficile External Control Kit is required for routine Quality Control.

The illumigene C. difficile DNA amplification assay 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 assay detects a partial DNA fragment on the Toxin A gene within the pathogenicity locus (PaLoc) of toxigenic C. difficile.

1. Table of acceptance criteria and reported device performance:

The document does not explicitly state pre-defined acceptance criteria values for sensitivity and specificity. However, based on the presented clinical trial results, the observed performance metrics can be considered the demonstrated performance of the device.

| Performance Metric | Acceptance Criteria (Implicit from reference K100818) | Reported Device Performance (Patients ≥ 2 years) | Reported Device Performance (Patients

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