QDC — Dna-Based Test For Minimal Residual Disease For Hematologic Malignancies Class II
FDA product code QDC covers "Dna-Based Test For Minimal Residual Disease For Hematologic Malignancies", a Class II medical device regulated under 21 CFR 866.6100. Submissions are reviewed by the Pathology panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QDC
- Device Class
- Class II
- Regulation Number
- 866.6100
- Submission Type
- Review Panel
- PA
- Medical Specialty
- Pathology
- Implant
- No
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.