Cleared Traditional

Adaptive Biotechnologies clonoSEQ Assay (K200009) - FDA 510(k) Clearance

Class II Medical Genetics device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

K200009 is an FDA 510(k) clearance for the Adaptive Biotechnologies clonoSEQ Assay. Classified as Dna-based Test For Minimal Residual Disease For Hematologic Malignancies (product code QDC), Class II - Special Controls.

Submitted by Adaptive Biotechnologies Corporation (Seattle, US). The FDA issued a Cleared decision on August 5, 2020 after a review of 216 days - an extended review cycle.

This device falls under the Medical Genetics FDA review panel, regulated under 21 CFR 866.6100 - the FDA medical genetics device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Medical Genetics review framework, consistent with the majority of Class II 510(k) submissions.

View all Adaptive Biotechnologies Corporation devices

Submission Details

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
183d faster than avg
Panel avg: 399d · This submission: 216d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QDC Dna-based Test For Minimal Residual Disease For Hematologic Malignancies
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Medical Genetics devices follow this clearance model.