Device |
cytomegalovirus (cmv) dna quantitative assay |
Regulation Description |
Quantitative cytomegalovirus nucleic acid tests for transplant patient management. |
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. |
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 |
Regulation Medical Specialty |
Microbiology |
Review Panel |
Microbiology |
Product Code | PAB |
Premarket Review |
Division of Microbiology Devices
(DMD)
Division of Microbiology Devices
(DMD)
|
Submission Type |
510(k)
|
Regulation Number |
866.3180
|
Device Class |
2
|
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
|
Third Party Review |
Not Third Party Eligible |