Agendia: FDA clearances and approvals
Agendia has 5 FDA 510(k) clearances (first 2009, latest 2022), across 1 product code in 1 review panel. Median 510(k) review time: 266 days. openFDA lists 1 product recall by a recalling firm named Agendia. It is the industry lead sponsor of 1 device clinical trial on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 1 | 266 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 120 |
| 2021 | 0 | — |
| 2022 | 1 | 526 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Agendia's cleared 510(k)s took a median 323 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 323 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NYI | Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer | 5 | 5 |
Review panels
- Pathology (5)
Most recent Agendia 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K210973 | MammaPrint FFPE NGS Kit | NYI | 2022-09-08 | 526 |
| K201902 | MammaPrint | NYI | 2020-11-05 | 120 |
| K141142 | MAMMAPRINT FFPE | NYI | 2015-01-23 | 266 |
| K101454 | MAMMAPRINT | NYI | 2011-01-28 | 248 |
| K081092 | MODIFICATION TO MAMMAPRINT | NYI | 2009-12-11 | 603 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2010-03-03.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Agendia is the industry lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT01617954: PRospective Study Of MammaPrint in Patients With an Intermediate Recurrence Score (Completed, started 2012-05)
Frequently asked questions
How many FDA 510(k) clearances does Agendia have?
Agendia has 5 FDA 510(k) clearances (first 2009, latest 2022), across 1 product code in 1 review panel.
How long does FDA take to clear Agendia's 510(k)s?
The median time from FDA receipt to decision across Agendia's cleared 510(k)s is 266 days.
What devices does Agendia make?
Its most frequent FDA product codes are NYI (Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer, 5).
Has Agendia had device recalls?
openFDA lists 1 product recall in 1 recall event by a recalling firm whose name matches Agendia; the most recent began 2010-03-03. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 5 Agendia clearances with predicates and recalls
- Run predicate analysis for product code NYI, Agendia's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.