FDA cleared the cobas liat CT/NG/MG nucleic acid test from Roche Molecular Systems, Inc. on May 15, 2026 under K253759, a dual track 510(k). The device falls under product code QEP, Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections, regulated at 21 CFR 866.3393 as a Class 2 device. The review panel was Microbiology.
FDA logged the submission as received on Nov 25, 2025. The decision came 171 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: 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).