510(k) K210973
K210973 is an FDA 510(k) premarket notification submitted by Agendia, Inc. for the device "MammaPrint FFPE NGS Kit". The FDA issued a decision of Substantially Equivalent on September 8, 2022. The device falls under product code NYI (Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer), a Class II device regulated under 21 CFR 866.6040. Agendia, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 8, 2022
- Date Received
- March 31, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer
- Device Class
- Class II
- Regulation Number
- 866.6040
- Review Panel
- PA
- Submission Type
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.