K243935 is an FDA 510(k) clearance for the Aptima CMV Quant Assay. This device is classified as a Cytomegalovirus (cmv) Dna Quantitative Assay (Class II - Special Controls, product code PAB).
Submitted by Hologic, Inc. (San Diego, 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 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 | K243935 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| 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. |