clonoSEQ Assay
by Adaptive Biotechnologies Corporation De Novo
Active
De Novo DEN170080
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA De NovoDENG | NumberDEN170080 | Date28 Sep 2018 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA De Novo Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- Full name
- Adaptive Biotechnologies clonoSEQ Assay
- De Novo Number
- FDA Product Code
- QDC
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.6100
- Advisory Committee
- Pathology
- FDA Decision
- DENG De Novo granted
Overview
AI-generated summary, 1 Oct 2026
The clonoSEQ Assay is a DNA-based test for minimal residual disease in hematologic malignancies, classified under the nomenclature for DNA-Based Test for Minimal Residual Disease for Hematologic Malignancies. It employs next-generation sequencing (NGS) to detect and quantify clonal immunoglobulin or T-cell receptor gene rearrangements, enabling precise monitoring of residual disease in patients with lymphoid cancers, including multiple myeloma, B-cell acute lymphoblastic leukemia (B-ALL), and chronic lymphocytic leukemia (CLL).
This assay is supplied as an in vitro diagnostic (IVD) test service and is intended for use in clinical pathology laboratories. It is designed for single-use on bone marrow or blood samples and requires no additional sterilization or reprocessing. The device is regulated under FDA 510(k) clearance (K170080) and falls under device classification II (QDC product code). Storage and handling follow standard laboratory protocols for nucleic acid testing, with no specific MRI safety considerations.
Other devices from Adaptive Biotechnologies
Questions
AI-generated answers, 1 Oct 2026
What is the clonoSEQ Assay used for?
The clonoSEQ Assay is a DNA-based test designed to detect and quantify minimal residual disease in patients with hematologic malignancies, specifically lymphoid cancers such as multiple myeloma, B-cell acute lymphoblastic leukemia (B-ALL), and chronic lymphocytic leukemia (CLL). It achieves this by analyzing clonal immunoglobulin or T-cell receptor gene rearrangements through next-generation sequencing (NGS), enabling precise monitoring of residual disease levels.
How is the clonoSEQ Assay supplied and used?
The clonoSEQ Assay is supplied as an in vitro diagnostic (IVD) test service intended for use in clinical pathology laboratories. It is specifically designed for single-use on bone marrow or blood samples. Since it is a service-based assay, no additional sterilization or reprocessing is required, as it is not a physical device that can be reused.
Is the clonoSEQ Assay single-use or reusable?
The clonoSEQ Assay is strictly for single-use only. It is not a physical device that can be sterilized or reprocessed for repeated use. Each test is performed on a dedicated sample, ensuring accuracy and preventing cross-contamination.
What storage and handling requirements does the clonoSEQ Assay have?
The clonoSEQ Assay follows standard laboratory protocols for nucleic acid testing, which include proper storage and handling to maintain sample integrity. There are no specific additional storage instructions beyond those typically used for nucleic acid-based assays. It is important to adhere to laboratory best practices to ensure reliable results.
Does the clonoSEQ Assay require any special regulatory considerations?
The clonoSEQ Assay is regulated under FDA 510(k) clearance (K170080) and falls under device classification II with the QDC product code. This classification indicates it is an in vitro diagnostic device intended for clinical use in pathology laboratories. The assay is not associated with MRI safety considerations, as it is a laboratory-based test.