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.
Kit, Test,Alpha-Fetoprotein For Testicular Cancer
Immunology
Kit, Test, Alpha-Fetoprotein for Testicular Cancer is a diagnostic immunoassay kit used to measure alpha-fetoprotein (AFP) levels in serum as a tumor marker for testicular germ cell tumors (particularly non-seminomatous tumors), used in initial diagnosis, staging, monitoring of treatment response, and surveillance for recurrence. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket clearance. The product code is LOJ, regulated under 21 CFR 866.6010, within the Immunology medical specialty. This device is eligible for third-party 510(k) review.
510(k) Clearances
17 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.