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.
Test, Urea (Breath Or Blood)
Microbiology
A Urea Breath or Blood Test is a diagnostic device used to detect the presence of Helicobacter pylori infection in the stomach by measuring labeled carbon dioxide exhaled after ingesting labeled urea, or by measuring blood-based urea markers, supporting diagnosis and post-treatment assessment. It is classified as FDA Class 1 with product code MSQ, regulated under 21 CFR 866.3110 in the Microbiology specialty. GMP requirements apply and no premarket submission is needed. The device is not an implant and is not life-sustaining.
510(k) Clearances
17 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.