510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K200009Substantially Equivalent

Adaptive Biotechnologies clonoSEQ Assay

Adaptive Biotechnologies, Seattle WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K200009 is the FDA 510(k) clearance record for Adaptive Biotechnologies clonoSEQ Assay, a class II device, cleared for Adaptive Biotechnologies Corporation on under FDA product code QDC (Dna-Based Test For Minimal Residual Disease For Hematologic Malignancies). FDA's definition for product code QDC reads: "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...". FDA records list 2 510(k) clearances for Adaptive Biotechnologies Corporation, from to . As of , FDA records show no recalls naming K200009.

Clearance record

Decision date
Received
(216 days to decision)
Product code
QDC Dna-Based Test For Minimal Residual Disease For Hematologic Malignancies
Regulation
21 CFR 866.6100
Device class
Class II
Review panel
Pathology
Applicant
Adaptive Biotechnologies Corporation 1551 Eastlake Ave. E., Suite 200, Seattle WA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QDC

Trailing 12 months

FDA records hold no clearances under product code QDC in the trailing twelve months.

FDA records show no clearances under product code QDC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QDC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260