cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System (07454945190); cobas® Cdiff Positive and Negative Control Kit for use on the cobas® Liat® System (07454970190)

FDA cleared the cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System (07454945190); cobas® Cdiff Positive and Negative Control Kit for use on the cobas® Liat® System (07454970190) from Roche Molecular Systems, Inc. on Aug 28, 2026 under K260045, a traditional 510(k). The device falls under product code OZN, C. Difficile Toxin Gene Amplification Assay, regulated at 21 CFR 866.3130 as a Class 2 device. The review panel was Microbiology.

FDA logged the submission as received on Jan 7, 2026. The decision came 233 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Roche Molecular Systems, Inc. has 8 other decisions in the tracker over the last 12 months: K260047 (cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190); cobas Strep A Quality Control Kit (07402678190)), K260021 (cobas® BV/CV), K260917 (cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the cobas 5800/6800/8800 systems), K253756 (cobas liat CT/NG nucleic acid test).