# K081092: Modification to Mammaprint

- Pathway: 510(k) (Traditional)
- Applicant: Agendia
- Decided: Dec 11, 2009 after 603 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to DEN070009 (2007). 3 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080252: Modification to Mammaprint, Agendia BV (2008). Cleared while this submission was under review Summary page 1.

## Most influential descendants
- K101454: Mammaprint (2011), 3 descendants of its own
- K141142: Mammaprint Ffpe (2015), 2 descendants of its own
- K201902: MammaPrint (2020), 1 descendant of its own
- K130010: Prosigna (TM) Breast Cancer Prognostic Gene Signature Assay (2013), 1 descendant of its own
- K210973: MammaPrint FFPE NGS Kit (2022), 0 descendants of its own

## Recalls of this device
- Mar 3, 2010 · Not classified · Z-1321-2010: Over a period of about 6 months in about 15% of results provided Agendia has been "over reporting" the chance of metastasis risk being 29% risk of recurrence instead of 10% risk. This over reporting o

## Indications for use
MammaPrint® is a qualitative in vitro diagnostic test service, performed in a single 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 II disease, with a tumor size of ≤ 5.0 cm and lymph node negative. The MammaPrint result is indicated for use by physicians as a prognostic marker only, along with other clinicopathological factors.

Source page: https://510kreport.com/device/K081092
Methodology: https://510kreport.com/methodology