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.
System, Test, Carcinoembryonic Antigen
Immunology
The Carcinoembryonic Antigen (CEA) Test System is a diagnostic immunoassay used to detect and measure carcinoembryonic antigen in blood, a tumor marker used in monitoring certain cancers, particularly colorectal cancer, and assessing treatment response. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is regulated under 21 CFR 866.6010 within the Immunology specialty. This device qualifies for third-party 510(k) review.
510(k) Clearances
28 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.