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.
Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)
Clinical Chemistry
This device is a colorimetric clinical chemistry reagent system using the diazo reaction to qualitatively detect nitrite in urine on a non-quantitative basis, used as part of urinalysis test strips or reagent panels to screen for urinary tract infections caused by nitrite-producing bacteria. It is classified as FDA Class 1, subject only to general controls with no premarket submission required. The product code is JMT, regulated under 21 CFR 862.1510, and assigned to the Clinical Chemistry medical specialty.
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.