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.
Electrophoretic, Protein Fractionation
Clinical Chemistry
The Electrophoretic Protein Fractionation Test is a clinical chemistry device that uses electrophoresis to separate serum proteins into distinct fractions (albumin, alpha-1, alpha-2, beta, and gamma globulins) based on their charge and size, used in the diagnosis of monoclonal gammopathies, liver disease, and inflammatory conditions. It is classified as FDA Class 1 (lowest risk), subject only to general controls, and is exempt from premarket notification. The product code is CEF, regulated under 21 CFR 862.1630, within the Clinical Chemistry medical specialty. No special flags apply to this device.
510(k) Clearances
29 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.