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.
Drug Metabolizing Enzyme Genotyping Systems
Clinical Toxicology
The Drug Metabolizing Enzyme Genotyping System is a molecular diagnostic device intended to identify the presence or absence of human genotypic markers encoding drug-metabolizing enzymes using DNA from clinical samples. Results can be used as an aid in determining treatment choice and individualizing drug dosing for therapeutics metabolized primarily by the enzyme being tested. It is an FDA Class 2 device regulated under 21 CFR 862.3360 in the Clinical Toxicology specialty, with product code NTI, requiring 510(k) clearance. Third-party review is available. It is not an implant and does not provide life-sustaining support.
510(k) Clearances
11 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.