Cleared Traditional

Alinity m CMV

K243485 · Abbott Molecular, Inc. · Microbiology
Jul 2025
Decision
235d
Days
Class 2
Risk

About This 510(k) Submission

K243485 is an FDA 510(k) clearance for the Alinity m CMV, a Cytomegalovirus (cmv) Dna Quantitative Assay (Class II — Special Controls, product code PAB), submitted by Abbott Molecular, Inc. (Des Plaines, US). The FDA issued a Cleared decision on July 1, 2025, 235 days after receiving the submission on November 8, 2024. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3180.

Submission Details

510(k) Number K243485 FDA.gov
FDA Decision Cleared SESE
Date Received November 08, 2024
Decision Date July 01, 2025
Days to Decision 235 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.