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.
Column Chromatography & Color Development, Hydroxyproline
Clinical Chemistry
This device is a clinical chemistry reagent system using column chromatography followed by colorimetric development to measure hydroxyproline in patient specimens such as urine, used as a marker of collagen turnover and bone resorption relevant to metabolic bone diseases, Paget disease, and growth disorders. It is classified as FDA Class 1, subject only to general controls with no premarket submission required. The product code is JMM, regulated under 21 CFR 862.1400, and assigned to the Clinical Chemistry medical specialty.
510(k) Clearances
21 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.