Not Cleared Direct

Adaptive Biotechnologies clonoSEQ Assay (DEN170080) - FDA 510(k) Clearance

Class II Pathology device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN170080 · Adaptive Biotechnologies Corporation · Pathology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2018
Decision
364d
Days
Class 2
Risk

DEN170080 is an FDA 510(k) submission (not cleared) 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 Not Cleared (DENG) decision on September 28, 2018 after a review of 364 days.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 866.6100 - the FDA pathology device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 364 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Adaptive Biotechnologies Corporation devices

Submission Details

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 -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
287d slower than avg
Panel avg: 77d · This submission: 364d
Pathway characteristics

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 Pathology devices follow this clearance model.