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. 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-B+ toxinotypes.

The illumigene C. difficile DNA amplification assay, performed on the illumipro
illumigene C. difficile - 280050

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid, including specific gene markers from Clostridium difficile bacteria in a clinical specimen and/or culture isolate, using a nucleic acid technique (NAT). Markers detected may include genes conferring antimicrobial resistance (e.g., gyrA gene), virulence (e.g., ribotype 027) and genes encoding toxin A and/or B.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: OMN

Device Name: C. Difficile Nucleic Acid Amplification Test Assay

Device Class: 1

Physical State: kIt containing DNA positive control, DNA internal control, buffer containing deoxyribonucleic acids and magnesium chloride, DNA polymerase, DNA primers and DNA probes

Definition: In vitro diagnostic test for the qualitative detection of toxigenic clostridium difficile nucleic acids isolated and purified from stool specimens obtained from symptomatic patients.

Submission Type ID: 4

Review Panel: MI

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Nucleic acid amplification test

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Stool samples

Regulation Number: 866.2660

Third Party Flag: N

Medical Specialty: MI

Device Id: 00840733101168

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A