PROSIGNA(TM) BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY
FDA 510(k) clearance K130010 · decided 2013-09-06
Clearance details
- K-number
- K130010
- Device name
- PROSIGNA(TM) BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY
- Applicant
- Nanostring Technologies
- Decision
- Substantially Equivalent
- Date received
- 2013-01-03
- Decision date
- 2013-09-06
- Days to decision
- 246 days
- Clearance type
- Traditional
- Product code
- NYI
- Device class
- 2
- Regulation number
- 866.6040
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Seattle, WA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Nanostring Technologies
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MammaPrint FFPE NGS Kit (K210973) | Agendia, Inc. | 2022-09-08 |
| MammaPrint (K201902) | Agendia, Inc. | 2020-11-05 |
| MAMMAPRINT FFPE (K141142) | Agendia | 2015-01-23 |
| PROSIGNA BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY (K141771) | Nanostring Technologies, Inc. | 2014-11-07 |
| MAMMAPRINT (K101454) | Agendia | 2011-01-28 |
| MODIFICATION TO MAMMAPRINT (K081092) | Agendia | 2009-12-11 |
| MODIFICATION TO MAMMAPRINT (K080252) | Agendia BV | 2008-07-21 |
| MAMMAPRINT (K070675) | Agendia BV | 2007-06-22 |
| MAMMAPRINT (DEN070009) | Agendia BV | 2007-02-06 |
Recalls involving this device
No recalls on record reference this clearance.