Adaptive Biotechnologies Corporation: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Adaptive Biotechnologies Corporation” (first 2020, latest 2020), plus 1 De Novo decision, across 1 product code in 1 review panel. Median 510(k) review time under this name: 216 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2020 | 1 | 216 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Adaptive Biotechnologies Corporation took a median 216 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 216 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QDC | Dna-Based Test For Minimal Residual Disease For Hematologic Malignancies | 2 | 1 |
Review panels
- Pathology (2)
Most recent Adaptive Biotechnologies Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K200009 | Adaptive Biotechnologies clonoSEQ Assay | QDC | 2020-08-05 | 216 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN170080 | De Novo | Dna-Based Test For Minimal Residual Disease For Hematologic Malignancies | 2018-09-28 |
Recalls
openFDA lists no recalls under a recalling firm named Adaptive Biotechnologies Corporation.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Adaptive Biotechnologies Corporation is the lead sponsor of 3 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT05255354: Optimizing ctDNA-based MRD Assessment in DLBCL, MCL, and FL Patients Undergoing CAR Therapy (Recruiting, started 2022-06-01)
- NCT05054088: ImmuneSense COVID-19 Variant Study (Completed, started 2021-10-12)
- NCT04583982: ImmuneSense™ COVID-19 Study (Completed, started 2020-10-09)
SEC filings
Adaptive Biotechnologies Corp (ADPT): EDGAR filings, CIK 1478320. An SEC registrant with the same name, matched by name only.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Adaptive Switch Laboratories, Inc. (4 510(k)s)
- Adaptive Video, Inc. (3 510(k)s)
- Adaptive Specialty, LLC (2 510(k)s)
- Adaptive Healthcare Technologies, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Adaptive Biotechnologies Corporation?
FDA lists 1 510(k) clearance under the applicant name “Adaptive Biotechnologies Corporation” (first 2020, latest 2020), plus 1 De Novo decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Adaptive Biotechnologies Corporation?
The median time from FDA receipt to decision across 510(k)s cleared under the name Adaptive Biotechnologies Corporation is 216 days.
Which FDA product codes appear under Adaptive Biotechnologies Corporation?
The most frequent FDA product codes under this applicant name are QDC (Dna-Based Test For Minimal Residual Disease For Hematologic Malignancies, 2).
Next steps
- See all 1 Adaptive Biotechnologies Corporation clearances with predicates and recalls
- Run predicate analysis for product code QDC, Adaptive Biotechnologies Corporation's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.