Cleared Traditional

K252481 - cobas CMV (FDA 510(k) Clearance)

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

K252481 is an FDA 510(k) clearance for the cobas CMV. Classified as Cytomegalovirus (cmv) Dna Quantitative Assay (product code PAB), Class II - Special Controls.

Submitted by Roche Molecular Systems, Inc. (Pleasanton, US). The FDA issued a Cleared decision on November 3, 2025 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3180 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Roche Molecular Systems, Inc. devices

Submission Details

510(k) Number K252481 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 102d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PAB Cytomegalovirus (cmv) Dna Quantitative Assay
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.