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510(k) K252481

cobas CMV by Roche Molecular Systems, Inc. — Product Code PAB

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.

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  • K240217 — cobas® liat CT/NG nucleic acid test (January 17, 2025)
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Other clearances for product code PAB

  • K243485 — Alinity m CMV (July 1, 2025)
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