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.
Let the assistant find your predicates
Describe your device and the Research Assistant searches 510(k)s, compares intended use, and drafts a predicate shortlist — with citations.
Free to try · every answer cites its records
High Throughput Sequencing Based Tumor Profiling Test Of Circulating Cell-Free Nucleic Acids
Pathology
A high throughput sequencing-based tumor profiling test of circulating cell-free nucleic acids is a qualitative in vitro diagnostic next-generation sequencing test that analyzes cell-free nucleic acids from plasma of peripheral whole blood to detect mutations in targeted gene panels, aiding in the management of previously diagnosed cancer patients by qualified healthcare professionals; results are not prescriptive for specific therapeutic products. It is classified as FDA Class II (510(k) required) under regulation 866.6085 in the Pathology specialty, with product code SBY. The device is not an implant and does not support life-sustaining functions.
510(k) Clearances
1 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.