510(k) · Cleared
ClearedProsigna (TM) Breast Cancer Prognostic Gene Signature Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nanostring Technologies · NYI Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer
Cleared on Sep 6, 2013 as substantially equivalent to DEN070009 (Agendia BV, 2007) and 1 other predicate after a 246-day review. Its family tree reaches back 4 generations to 2007. 1 later device descends from it.
- Decided
- Sep 6, 2013
- Review
- 246 days
- Class
- Class II
- Product code
- NYI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to DEN070009 (2007). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backDEN070009 MammaprintAgendia BV · 2007
- 3 generations backK070675 MammaprintAgendia BV · 2007 · Recalled
- 2 generations backK080252 Modification to MammaprintAgendia BV · 2008 · Recalled
- 1 generation backK081092 Modification to MammaprintAgendia · 2009 · Recalled
- This deviceK130010 Prosigna (TM) Breast Cancer Prognostic Gene Signature AssayNanostring Technologies · 2013
- Descendant · cites it directly · 0 of its ownK141771 Prosigna Breast Cancer Prognostic Gene Signature AssayNanostring Technologies, Inc. · 2014
Most influential descendants
Showing 1 of 1 · See all- K141771Prosigna Breast Cancer Prognostic Gene Signature AssayNanostring Technologies, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | DEN070009 | Mammaprint | Agendia BV | 2007 | — |
| −3 | K070675 | Mammaprint | Agendia BV | 2007 | 1 |
| −2 | K080252 | Modification to Mammaprint | Agendia BV | 2008 | 1 |
| −1 | K081092 | Modification to Mammaprint | Agendia | 2009 | 1 |
| 0 (this device) | K130010 | Prosigna (TM) Breast Cancer Prognostic Gene Signature Assay | Nanostring Technologies | 2013 | — |
| +1 | K141771 | Prosigna Breast Cancer Prognostic Gene Signature Assay | Nanostring Technologies, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NYI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NYI device
- #1 K210973 MammaPrint FFPE NGS Kitscore 5.8 · 7 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN070009 | Mammaprint 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. | 2007 |
| * | K081092 | Modification to MammaprintSummary page 12…nd Low risk groups (where indicated) as well as a continuous risk score that outputs an integer Prosigna Score of 0-100. Predicate Device: Agendia, MammaPrint K062694, K081092 Substantial Equivalence Comparison Table Device New Device (Prosigna™ Breast Predicate Device… | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141771 | Prosigna Breast Cancer Prognostic Gene Signature Assay | 2014 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
- 3 of the 4 ancestors have a recall of any class.
- Of its descendants, K141771 (Nanostring Technologies, Inc., 2014) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate DEN070009.
How does its category compare?
All NYI devicesNYI Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · NYI
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · NYI
Too few NYI 510(k)s in any year since 2007 to give a median.
Recalls per year · NYI
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NYI
1in 2023
MAUDE reports naming product code NYI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 1 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Prosigna™ Breast Cancer Prognostic Gene Signature Assay is an in vitro diagnostic assay which is performed on the NanoString nCounter® Dx Analysis System using FFPE breast tumor tissue previously diagnosed as invasive breast carcinoma. This qualitative assay utilizes gene expression data, weighted together with clinical variables to generate a risk category and numerical score, to assess a patient’s risk of distant recurrence of disease. The Prosigna…
Read the full statement (220 words)
The Prosigna™ Breast Cancer Prognostic Gene Signature Assay is an in vitro diagnostic assay which is performed on the NanoString nCounter® Dx Analysis System using FFPE breast tumor tissue previously diagnosed as invasive breast carcinoma. This qualitative assay utilizes gene expression data, weighted together with clinical variables to generate a risk category and numerical score, to assess a patient’s risk of distant recurrence of disease.
The Prosigna Breast Cancer Prognostic Gene Signature Assay is indicated in female breast cancer patients who have undergone surgery in conjunction with locoregional treatment consistent with standard of care, either as:
1. A prognostic indicator for distant recurrence-free survival at 10 years in post-menopausal women with Hormone Receptor-Positive (HR+), lymph node-negative, Stage I or II breast cancer to be treated with adjuvant endocrine therapy alone, when used in conjunction with other clinicopathological factors.
2. A prognostic indicator for distant recurrence-free survival at 10 years in post-menopausal women with Hormone Receptor-Positive (HR+), lymph node-positive (1-3 positive nodes), Stage II breast cancer to be treated with adjuvant endocrine therapy alone, when used in conjunction with other clinicopathological factors. The device is not intended for patients with 4 or more positive nodes.
Special Conditions for Use: Prosigna is not intended for diagnosis, to predict or detect response to therapy, or to help select the optimal therapy for patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130010 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130010: Prosigna (TM) Breast Cancer Prognostic Gene Signature Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130010
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026