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.
Genetic Variant Detection And Health Risk Assessment System
Immunology
The Genetic Variant Detection and Health Risk Assessment System is a qualitative in vitro molecular test that detects variants in genomic DNA from human specimens to provide users with a genetic health risk assessment of developing certain diseases, intended for over-the-counter use to inform lifestyle choices and encourage conversations with healthcare professionals. It is classified as FDA Class 2 under 21 CFR 866.5950 in the Immunology specialty, exempt from 510(k) premarket notification requirements (de novo or notification exemption). The device does not determine an individual's overall disease risk. Product code PTA; not an implant and not life-sustaining.
510(k) Clearances
5 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.