K201902 is an FDA 510(k) clearance for the MammaPrint. This device is classified as a Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer (Class II - Special Controls, product code NYI).
Submitted by Agendia, Inc. (Irvina, US). The FDA issued a Cleared decision on November 5, 2020, 120 days after receiving the submission on July 8, 2020.
This device falls under the Pathology FDA review panel. Regulated under 21 CFR 866.6040. 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..
| 510(k) Number | K201902 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 08, 2020 |
| Decision Date | November 05, 2020 |
| Days to Decision | 120 days |
| Submission Type | Traditional |
| Review Panel | Pathology (PA) |
| Summary | Summary PDF |
| Product Code | NYI - Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.6040 |
| 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. |