NYI
10 FDA 510(k) clearances · Product code
246 daysmedian time to decision
603 days90th percentile
10clearances measured
FDA profile
- Official device name
- Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.6040
- Medical specialty
- Immunology
- FDA definition
- A device which uses a gene expression profile of a breast cancer tumor, from patients stage i or stage ii lymph node negative, with a tumor size of <5.0 cm, to provide a risk assessment for distant recurrence of breast cancer. The result is indicated for use only as a prognostic marker by physicians along with a number of other factors to assess the risk of recurrence of breast cancer.
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| Record | Firm | Date |
|---|---|---|
| MammaPrint FFPE NGS Kit (K210973) | Agendia, Inc. | 2022-09-08 |
| MammaPrint (K201902) | Agendia, Inc. | 2020-11-05 |
| MAMMAPRINT FFPE (K141142) | Agendia | 2015-01-23 |
| PROSIGNA BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY (K141771) | Nanostring Technologies, Inc. | 2014-11-07 |
| PROSIGNA(TM) BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY (K130010) | Nanostring Technologies | 2013-09-06 |
| MAMMAPRINT (K101454) | Agendia | 2011-01-28 |
| MODIFICATION TO MAMMAPRINT (K081092) | Agendia | 2009-12-11 |
| MODIFICATION TO MAMMAPRINT (K080252) | Agendia BV | 2008-07-21 |
| MAMMAPRINT (K070675) | Agendia BV | 2007-06-22 |
| MAMMAPRINT (DEN070009) | Agendia BV | 2007-02-06 |
Track NYI automatically
Every clearance here is in the API, with alerts when new ones post.