# K070675: Mammaprint

- Pathway: 510(k) (Traditional)
- Applicant: Agendia BV
- Decided: Jun 22, 2007 after 102 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: 1 generation back to DEN070009 (2007). 1 ancestor in all.
8 later devices descend from it; 1 cites 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)
- DEN070009: Mammaprint, Agendia BV (2007). Our reading of the summary gave K062694, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN070009, Mammaprint (Agendia BV), granted Feb 6, 2007; older De Novo requests were first filed under a 510(k) number, so this links to the grant.

## Most influential descendants
- K080252: Modification to Mammaprint (2008), 7 descendants of its own
- K081092: Modification to Mammaprint (2009), 6 descendants of its own
- 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

## 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. The test is performed for breast cancer patients who are less than 61 years old, with Stage I or Stage II disease, with tumor size < 5.0 cm and lymph fiode 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/K070675
Methodology: https://510kreport.com/methodology