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.
Let the assistant find your predicates
Describe your device and the Research Assistant searches 510(k)s, compares intended use, and drafts a predicate shortlist — with citations.
Free to try · every answer cites its records
Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment
Immunology
The Alpha Fetoprotein L3 Subfraction (AFP-L3%) Test for Hepatocellular Carcinoma Risk Assessment is an in vitro diagnostic test intended to assess the risk of developing hepatocellular carcinoma (HCC) in patients with chronic liver diseases. Elevated AFP-L3% values of 10% or greater have been associated with a nine-fold increased risk of developing HCC within 6 to 12 months, and patients with elevated results should be more intensely evaluated according to existing HCC practice guidelines. It is an FDA Class 2 device regulated under 21 CFR 866.6030 in the Immunology specialty, with product code NSF, requiring 510(k) clearance and eligible for third-party review. It is not an implant and does not carry a life-sustaining support flag.
510(k) Clearances
2 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.