Agendia Inc
Irvine, CA, US
Agendia Inc appears in FDA device records in Irvine, CA. FDA records list 8 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 8 510(k) clearances for Agendia Inc between 2007 and 2022. The busiest year on record is 2007, with 2. The most recent is 2022, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2007 | 2 |
| 2008 | 1 |
| 2009 | 1 |
| 2011 | 1 |
| 2015 | 1 |
| 2020 | 1 |
| 2022 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K210973 | MammaPrint FFPE NGS Kit | NYI | Substantially Equivalent | |
| K201902 | MammaPrint | NYI | Substantially Equivalent | |
| K141142 | MAMMAPRINT FFPE | NYI | Substantially Equivalent | |
| K101454 | MAMMAPRINT | NYI | Substantially Equivalent | |
| K081092 | MODIFICATION TO MAMMAPRINT | NYI | Substantially Equivalent | |
| K080252 | MODIFICATION TO MAMMAPRINT | NYI | Substantially Equivalent | |
| K070675 | MAMMAPRINT | NYI | Substantially Equivalent | |
| DEN070009 | MAMMAPRINT | NYI | Unknown |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3007297853 | 3007297853 | Agendia Inc | 22 Morgan, Irvine, CA 92618 US | 2026 | |
| 3017845262 | 3017845262 | Agendia NV | Radarweg 60, Amsterdam Noord-Holland 1043 NT NL | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1321-2010 | 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 unnecessary therapy. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain