# DEN170080: Adaptive Biotechnologies clonoSEQ Assay

- Pathway: De Novo (Direct)
- Applicant: Adaptive Biotechnologies Corporation
- Decided: Sep 28, 2018 after 364 days
- Product code: QDC (Dna-Based Test For Minimal Residual Disease For Hematologic Malignancies)
- Device class: 2
- Regulation: 21 CFR 866.6100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K200009: Adaptive Biotechnologies clonoSEQ Assay (2020), 0 descendants of its own

## Indications for use
The clonoSEQ Assay is an in vitro diagnostic that uses multiplex polymerase chain reaction (PCR) and next-generation sequencing (NGS) to identify and quantify rearranged IgH (VDJ), IgH (DJ), IgK, and IgL receptor gene sequences, as well as translocated BCL1/IgH (J) and BCL2/IgH (J) sequences in DNA extracted from bone marrow from patients with B-Cell acute lymphoblastic leukemia (ALL) or multiple myeloma (MM). The clonoSEQ Assay measures minimal residual disease (MRD) to monitor changes in burden of disease during and after treatment. The test is indicated for use by qualified healthcare professionals in accordance with professional guidelines for clinical decision-making and in conjunction with other clinicopathological features. The clonoSEQ Assay is a single-site assay performed at Adaptive Biotechnologies Corporation.

Source page: https://510kreport.com/device/DEN170080
Methodology: https://510kreport.com/methodology