510(k) K252481
K252481 is an FDA 510(k) premarket notification submitted by Roche Molecular Systems, Inc. for the device "cobas CMV". The FDA issued a decision of Substantially Equivalent on November 3, 2025. The device falls under product code PAB (Cytomegalovirus (Cmv) Dna Quantitative Assay), a Class II device regulated under 21 CFR 866.3180. Roche Molecular Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 3, 2025
- Date Received
- August 7, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cytomegalovirus (Cmv) Dna Quantitative Assay
- Device Class
- Class II
- Regulation Number
- 866.3180
- Review Panel
- MI
- Submission Type
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.