Cleared Traditional

cobas CMV

K252481 · Roche Molecular Systems, Inc. · Microbiology
Nov 2025
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K252481 is an FDA 510(k) clearance for the cobas CMV, a Cytomegalovirus (cmv) Dna Quantitative Assay (Class II — Special Controls, product code PAB), submitted by Roche Molecular Systems, Inc. (Pleasanton, US). The FDA issued a Cleared decision on November 3, 2025, 88 days after receiving the submission on August 7, 2025. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3180.

Submission Details

510(k) Number K252481 FDA.gov
FDA Decision Cleared SESE
Date Received August 07, 2025
Decision Date November 03, 2025
Days to Decision 88 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code PAB — Cytomegalovirus (cmv) Dna Quantitative Assay
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3180
Definition Cytomegalovirus (cmv) Dna Quantitative Assay Is An In Vitro Nucleic Acid Assay For The Quantitative Measurement Of Cmv Dna In Human Plasma. The Assay Can Be Used To Measure Cmv Dna Levels Serially At Baseline And During The Course Of Antiviral Treatment To Assess Virological Response To Treatment. The Test Results Must Be Interpreted Within The Context Of All Relevant Clinical And Laboratory Findings.