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.
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Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System
Clinical Toxicology
The Cytochrome P450 2C9 (CYP450 2C9) Drug Metabolizing Enzyme Genotyping System (product code ODW) is a clinical toxicology in vitro diagnostic assay used to genotype CYP2C9 alleles, providing information to aid clinicians in determining therapeutic strategy for medications metabolized by the CYP2C9 enzyme, including warfarin and certain NSAIDs. CYP2C9 genotype influences drug metabolism rate and can predict adverse drug reactions or treatment failure. This device is FDA Class 2 under regulation 862.3360 in the Clinical Toxicology specialty, requires 510(k) clearance, and is eligible for third-party review. It carries no implant or life-sustaining flags.
510(k) Clearances
6 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.