Cleared Traditional

Adaptive Biotechnologies clonoSEQ Assay

K200009 · Adaptive Biotechnologies Corporation · Medical Genetics
Aug 2020
Decision
216d
Days
Class 2
Risk

About This 510(k) Submission

K200009 is an FDA 510(k) clearance for the Adaptive Biotechnologies clonoSEQ Assay, 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 review panel. Regulated under 21 CFR 866.6100.

Submission Details

510(k) Number K200009 FDA.gov
FDA Decision Cleared 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

Device Classification

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.