Cleared Special

Aptima CMV Quant Assay

K243935 · Hologic, Inc. · Microbiology
Jan 2025
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K243935 is an FDA 510(k) clearance for the Aptima CMV Quant Assay, a Cytomegalovirus (cmv) Dna Quantitative Assay (Class II — Special Controls, product code PAB), submitted by Hologic, Inc. (San Diedgo, US). The FDA issued a Cleared decision on January 17, 2025, 28 days after receiving the submission on December 20, 2024. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3180.

Submission Details

510(k) Number K243935 FDA.gov
FDA Decision Cleared SESE
Date Received December 20, 2024
Decision Date January 17, 2025
Days to Decision 28 days
Submission Type Special
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.