510(k) K101454
K101454 is an FDA 510(k) premarket notification submitted by Agendia for the device "MAMMAPRINT". The FDA issued a decision of Substantially Equivalent on January 28, 2011. 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 has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 28, 2011
- Date Received
- May 25, 2010
- 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.