K200009 is an FDA 510(k) clearance 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 Cleared decision on August 5, 2020, 216 days after receiving the submission on January 2, 2020.
This device falls under the Medical Genetics 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 | K200009 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 02, 2020 |
| Decision Date | August 05, 2020 |
| Days to Decision | 216 days |
| Submission Type | Traditional |
| Review Panel | Medical Genetics (MG) |
| Summary | Summary PDF |
| 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. |