510(k) Predicate Finder
Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.
Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer
Immunology
The Classifier, Prognostic, Recurrence Risk Assessment, RNA Gene Expression, Breast Cancer (product code NYI) is a molecular diagnostic device that uses the gene expression profile of a breast cancer tumor from Stage I or Stage II lymph node-negative patients to provide a prognostic risk assessment for distant recurrence of breast cancer. It is classified as FDA Class 2, requiring 510(k) clearance, and is regulated under 21 CFR 866.6040 within the Immunology specialty. The result is intended for use only in conjunction with other clinical and pathological factors to guide treatment decisions.
510(k) Clearances
10 matchesWhat is a Predicate Device?
A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.
Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.
Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.