The Alethia™ C. difficile DNA amplification assay, performed on the Alethia™ Instrument, 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 Alethia™ 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 Alethia™ 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 Alethia™ C. difficile DNA amplification assay, performed on the Alethia™ Instrument, 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
Alethia™ C. difficile - 480050

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: 00840733102172

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