# K101454: Mammaprint

- Pathway: 510(k) (Traditional)
- Applicant: Agendia
- Decided: Jan 28, 2011 after 248 days
- Product code: NYI (Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer)
- Device class: 2
- Regulation: 21 CFR 866.6040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to DEN070009 (2007). 4 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081092: Modification to Mammaprint, Agendia (2009) Summary page 1.

## Most influential descendants
- K141142: Mammaprint Ffpe (2015), 2 descendants of its own
- K201902: MammaPrint (2020), 1 descendant of its own
- K210973: MammaPrint FFPE NGS Kit (2022), 0 descendants of its own

## Indications for use
MammaPrint is aqualitative in vitro diagnostic test service, performed in a central laboratory, using the gene expression profile of fresh breast cancer tissue samples to assess a patients' risk for distant metastasis (up to 10 years for patients less than 61 years old, up to 5 years for patients' 61 years). The test is performed for breast cancer patients with Stage I or Stage 11disease, with a tumor size of 5 5.0 cm and lymph node negative. The MammaPrint result is indicated for use by physicians as a prognostic marker only, along with a other clinicopathological factors.

Source page: https://510kreport.com/device/K101454
Methodology: https://510kreport.com/methodology