QDC

2 FDA 510(k) clearances · Product code

FDA profile

Official device name

Dna-Based Test For Minimal Residual Disease For Hematologic Malignancies

Device class

Class II (moderate risk)

Regulation

21 CFR 866.6100

Medical specialty

Pathology

FDA 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.

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