De Novo · Granted
GrantedAdaptive Biotechnologies clonoSEQ Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Adaptive Biotechnologies Corporation · QDC Dna-Based Test For Minimal Residual Disease For Hematologic Malignancies
Granted on Sep 28, 2018 as a new device type through De Novo after a 364-day review. 1 later device descends from it.
- Decided
- Sep 28, 2018
- Review
- 364 days
- Class
- Class II
- Product code
- QDC
- Recalls
- None
1 later device descends from it, 1 citing it directly.
- This deviceDEN170080 Adaptive Biotechnologies clonoSEQ AssayAdaptive Biotechnologies Corporation · 2018
- Descendant · cites it directly · 0 of its ownK200009 Adaptive Biotechnologies clonoSEQ AssayAdaptive Biotechnologies Corporation · 2020
Most influential descendants
Showing 1 of 1 · See all- K200009Adaptive Biotechnologies clonoSEQ AssayAdaptive Biotechnologies Corporation · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN170080 | Adaptive Biotechnologies clonoSEQ Assay | Adaptive Biotechnologies Corporation | 2018 | — |
| +1 | K200009 | Adaptive Biotechnologies clonoSEQ Assay | Adaptive Biotechnologies Corporation | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
Sources: FDA De Novo database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QDC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QDC device
- #1 K200009 Adaptive Biotechnologies clonoSEQ Assayscore -0.2 · 1 generation · no Class I recall
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200009 | Adaptive Biotechnologies clonoSEQ Assay | 2020 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K200009 (Adaptive Biotechnologies Corporation, 2020) has gone furthest, with 0 descendants of its own.
How does its category compare?
All QDC devicesQDC Dna-Based Test For Minimal Residual Disease For Hematologic Malignancies: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · QDC
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · QDC
Too few QDC 510(k)s in any year since 2007 to give a median.
Recalls per year · QDC
No recall names QDC since 2007.
Adverse event reports per year · QDC
No MAUDE report names QDC since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (118 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN170080 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN170080: Adaptive Biotechnologies clonoSEQ Assay.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN170080
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026