510(k) DEN170080
DEN170080 is an FDA 510(k) premarket notification submitted by Adaptive Biotechnologies Corporation for the device "Adaptive Biotechnologies clonoSEQ Assay". The FDA issued a decision of De Novo Granted on September 28, 2018. The device falls under product code QDC (Dna-Based Test For Minimal Residual Disease For Hematologic Malignancies), a Class II device regulated under 21 CFR 866.6100. Adaptive Biotechnologies Corporation has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- September 28, 2018
- Date Received
- September 29, 2017
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dna-Based Test For Minimal Residual Disease For Hematologic Malignancies
- Device Class
- Class II
- Regulation Number
- 866.6100
- Review Panel
- PA
- Submission Type
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.