cobas CMV
FDA 510(k) K252481 · Roche Molecular Systems, Inc.
510(k) numberK252481
Submission
- Device name
- cobas CMV
- Applicant
- Roche Molecular Systems, Inc.
Pleasanton, CA, US - Received
- August 7, 2025
- Decision date
- November 3, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PAB – Cytomegalovirus (Cmv) Dna Quantitative Assay
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3180
- Specialty
- Microbiology
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…
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Questions and answers
When was cobas CMV cleared by the FDA?
cobas CMV (K252481) received a 510(k) decision of Substantially Equivalent on November 3, 2025, 88 days after the submission was received.
What is the product code of K252481?
The FDA product code is PAB – Cytomegalovirus (Cmv) Dna Quantitative Assay, a Class II (moderate risk) device regulated under 21 CFR 866.3180.