Data / Medical devices / United States / Agendia Inc
Agendia Inc: FDA-registered device maker in Irvine, CA, United States, 2 510(k) clearances
Agendia Inc is registered with the FDA (registration 3007297853) in Irvine, CA, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated November 5, 2020. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007297853
- Address
- 22 Morgan, Irvine, CA, United States, 92618
- Owner or operator
- AGENDIA Inc. (9101719)
- Roles
- Manufacturer, Manufacturer for export
- First device listed
- November 27, 2018
- Registered through
- 2026
- Brand names listed
- Agendia Specimen Collection Kit, MammaPrint® BluePrint® Breast Cancer Recurrence and Molecular Subtyping Kit, MammaPrint® FFPE
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer | NYI | 2 | Manufacturer, Manufacturer for export | accessdata.fda.gov |
| Container, Specimen Mailer And Storage, Non-Sterile | NNK | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 5, 2020 | K201902 | MammaPrint | NYI | Substantially Equivalent | Agendia, Inc. | accessdata.fda.gov |
| January 23, 2015 | K141142 | MAMMAPRINT FFPE | NYI | Substantially Equivalent | Agendia | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| March 3, 2010 | 54930 | Not yet classified | Terminated | Agendia MammaPrint, Catalog Numbers MP01, MP US version 03 | Over a period of about 6 months in about 15% of results provided Agendia has been "over reporting" the chance of metastasis risk being 29% risk of recurrence instead of 10% risk. This over reporting of risk did not cause direct injury to patients. However, if used by physicians as the sole basis for decision-making, affected patients may have received unnece | accessdata.fda.gov |
Compare with other makers
- All makers of Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer
- All makers of Container, Specimen Mailer And Storage, Non-Sterile
Updated November 5, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.