510(k) K260047

cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190); cobas Strep A Quality Control Kit (07402678190) by Roche Molecular Systems, Inc. — Product Code PGX

K260047 is an FDA 510(k) premarket notification submitted by Roche Molecular Systems, Inc. for the device "cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190); cobas Strep A Quality Control Kit (07402678190)". The FDA issued a decision of Substantially Equivalent on August 28, 2026. The device falls under product code PGX (Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System), a Class II device regulated under 21 CFR 866.2680. Roche Molecular Systems, Inc. has at least 10 other 510(k) clearances on record.