510(k) · Cleared
ClearedAdaptive 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
Cleared on Aug 5, 2020 as substantially equivalent to DEN170080 (Adaptive Biotechnologies Corporation, 2018) after a 216-day review. Its family tree reaches back 1 generation to 2018.
- Decided
- Aug 5, 2020
- Review
- 216 days
- Class
- Class II
- Product code
- QDC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN170080 (2018). No later device cites it as a predicate yet.
- Root · 1 generation backDEN170080 Adaptive Biotechnologies clonoSEQ AssayAdaptive Biotechnologies Corporation · 2018
- This deviceK200009 Adaptive Biotechnologies clonoSEQ AssayAdaptive Biotechnologies Corporation · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN170080 | Adaptive Biotechnologies clonoSEQ Assay | Adaptive Biotechnologies Corporation | 2018 | — |
| 0 (this device) | K200009 | Adaptive Biotechnologies clonoSEQ Assay | Adaptive Biotechnologies Corporation | 2020 | — |
Sources: FDA 510(k) 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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN170080 | Adaptive Biotechnologies clonoSEQ AssaySummary page 9…ith Predicate Similarities and Differences Item Device Predicate (DEN170080) Device Same Adaptive clonoSEQ® Assay Intended Use… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
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. 2020, 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), and blood or bone marrow from patients with…
Read the full statement (130 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), and blood or bone marrow from patients with chronic lymphocytic leukemia (CLL).
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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K200009 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200009: Adaptive Biotechnologies clonoSEQ Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200009
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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