Product code QDC— Pathology
Adaptive Biotechnologies clonoSEQ Assay
- Classification name
- Dna-Based Test For Minimal Residual Disease For Hematologic Malignancies
- Device class
- Class 2
- Regulation
- 21 CFR 866.6100
- Advisory panel
- Pathology
- Total cleared
- 2
- First cleared
- Most recent
FDA classification 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.”
Market context for product code QDC
FDA has cleared devices under product code QDC between 2018 and 2020, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2020
- 2018
Top applicants under product code QDC
Recent clearances under product code QDC
Data sourced from openFDA. This site is unofficial and independent of the FDA.