Dna-Based Test For Minimal Residual Disease For Hematologic Malignancies
Medical specialty
Pathology
Device class
2
Regulation number
866.6100
Review panel
PA
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
Definition
A DNA-based test for minimal residual disease is an in vitro diagnostic device that identifies and quantifies specific nucleic acid sequences isolated from human specimens to estimate the percentage of cells that harbor the specific sequence(s). The test is intended to be used as an aid to measure minimal residual disease to monitor the change in burden of disease for patients with a hematological malignancy during and after treatment. The results should be interpreted by a pathologist or equivalent professional in conjunction with other clinical and laboratory findings.