DEN170080 is an FDA 510(k) submission for the Adaptive Biotechnologies clonoSEQ Assay. This device is classified as a Dna-based Test For Minimal Residual Disease For Hematologic Malignancies (Class II - Special Controls, product code QDC).
Submitted by Adaptive Biotechnologies Corporation (Seattle, US). The FDA issued a Not Cleared (DENG) decision on September 28, 2018.
This device falls under the Pathology FDA review panel. Regulated under 21 CFR 866.6100. 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..
| 510(k) Number | DEN170080 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | September 29, 2017 |
| Decision Date | September 28, 2018 |
| Days to Decision | 364 days |
| Submission Type | Direct |
| Review Panel | Pathology (PA) |
| Summary | - |
| Product Code | QDC - Dna-based Test For Minimal Residual Disease For Hematologic Malignancies |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.6100 |
| 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. |