510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K210973Substantially Equivalent

MammaPrint FFPE NGS Kit

Agendia Inc, Irvina CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K210973 is the FDA 510(k) clearance record for MammaPrint FFPE NGS Kit, a class II device, cleared for Agendia, Inc. on under FDA product code NYI (Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer). FDA's definition for product code NYI reads: "A device which uses a gene expression profile of a breast cancer tumor, from patients stage i or stage ii lymph node negative, with a tumor size of <5.0 cm, to provide a risk assessment for distant recurrence of breast cancer. The result...". FDA records list 8 510(k) clearances for Agendia, Inc., from to . As of , FDA records show no recalls naming K210973.

Clearance record

Decision date
Received
(526 days to decision)
Product code
NYI Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer
Regulation
21 CFR 866.6040
Device class
Class II
Review panel
Immunology
Applicant
Agendia, Inc. 22 Morgan, Irvina CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NYI

Trailing 12 months

FDA records hold no clearances under product code NYI in the trailing twelve months.

FDA records show no clearances under product code NYI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NYI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260