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# FDA Clears Roche Cobas C-diff Test
- URL: https://www.fdaweb.com/fda-clears-roche-cobas-c-diff-test/
- Published: 2017-10-09T12:00:00.000Z
- Updated: 2026-09-14T22:55:00.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139822

FDA has cleared a Roche 510(k) for the Cobas C-diff Nucleic acid test for detecting the toxin B (tcdB) gene of toxigenic *Clostridium difficile.* The automated qualitative *in vitro* diagnostic test uses real-time polymerase chain reaction to detect the tcdB gene in soft or liquid stool specimens obtained from patients suspected of having *C. difficile* infection. It detects tcdB target-specific and IC-specific oligonucleotide sequences, the company says.