FDA cleared the cobas HCV from Roche Molecular Systems, Inc. on Nov 3, 2025 under K252484, a traditional 510(k). The device falls under product code MZP, Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus, regulated at 21 CFR 866.3170 as a Class 2 device. The review panel was Microbiology.
FDA logged the submission as received on Aug 7, 2025. The decision came 88 days later, inside the 90 FDA-day goal for a 510(k).
Roche Molecular Systems, Inc. has 8 other decisions in the tracker over the last 12 months: 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)), 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).