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.
Antigen, Enzyme Linked Immunoabsorbent Assay, Neisseria Gonorrhoeae
Microbiology
An enzyme-linked immunosorbent assay (ELISA) antigen test for Neisseria gonorrhoeae is a laboratory diagnostic test that uses an ELISA format to detect gonorrhea-specific antigens in clinical specimens, providing a non-culture approach to diagnosing gonorrheal infection in the microbiology laboratory. The device is FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. It bears product code LIR and is regulated under 21 CFR 866.3390 within the Microbiology specialty. This device is eligible for third-party review.
510(k) Clearances
3 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.