Product Classification

• Device: cytomegalovirus (cmv) dna quantitative assay
• Definition: Cytomegalovirus (CMV) DNA Quantitative Assay is an in vitro nucleic acid assay for the quantitative measurement of CMV DNA in human plasma or whole blood. 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.
• Physical State: IVD
• Technical Method: In vitro nucleic acid based assay using real-time PCR for the quantitative measurement of CMV DNA
• Target Area: Not Applicable
• Review Panel: Microbiology
• Product Code: PAB
• Premarket Review: Office of In Vitro Diagnostics (OHT7); Division of Microbiology Devices (DMD)
• Submission Type: PMA
• Device Class: 3
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Ineligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Recognized Consensus Standard

• 7-238 CLSI MM06-A2 (Replaces MM06-A)
  Quantitative Molecular Methods for Infectious Diseases; Approved Guideline - Second Edition

Third Party Review

Not Third Party Eligible