510(k) K260045

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) by Roche Molecular Systems, Inc. — Product Code OZN

K260045 is an FDA 510(k) premarket notification submitted by Roche Molecular Systems, Inc. for the device "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)". The FDA issued a decision of Substantially Equivalent on August 28, 2026. The device falls under product code OZN (C. Difficile Toxin Gene Amplification Assay), a Class II device regulated under 21 CFR 866.3130. Roche Molecular Systems, Inc. has at least 10 other 510(k) clearances on record.