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.
Starch-Dye Bound Polymer, Amylase
Clinical Chemistry
The Starch-Dye Bound Polymer, Amylase test system (product code CIW) is an in-vitro diagnostic device used in clinical chemistry to measure amylase activity in serum or urine using a substrate consisting of a dye-bound starch polymer; amylase cleaves the substrate, releasing colored fragments that are quantified photometrically. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification. It falls under regulation 21 CFR 862.1070 in the Clinical Chemistry medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.
510(k) Clearances
8 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.