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.
High Pressure Liquid Chromatography, Cocaine And Cocaine Metabolites
Clinical Toxicology
High pressure liquid chromatography for cocaine and cocaine metabolites is a laboratory analytical method used in clinical toxicology to detect and quantify cocaine and its breakdown products in biological specimens. The device is FDA Class 2, meaning it requires 510(k) premarket clearance to demonstrate moderate-risk controls are in place. The product code is LAC, regulated under 21 CFR 862.3250, within the Clinical Toxicology specialty. It qualifies for third-party review.
No 510(k) clearances found for "LAC". Try a different K-number, product code, or device name.
What 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.