K243485 is an FDA 510(k) clearance for the Alinity m CMV. This device is classified as 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 FDA review panel. Regulated under 21 CFR 866.3180. 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..
| 510(k) Number | K243485 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| 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. |