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.
Gonococcal Antibody Tests
Microbiology
Gonococcal antibody tests are laboratory diagnostic devices used to detect antibodies against Neisseria gonorrhoeae in patient specimens, supporting the serological diagnosis of gonorrhea infection. The device is FDA Class 3, the highest risk category, requiring Pre-Market Approval (PMA) to demonstrate safety and effectiveness prior to marketing. It carries product code LGB and is regulated under 21 CFR 866.3290 within the Microbiology specialty. No special flags apply to this device.
No 510(k) clearances found for "LGB". Try a different K-number, product code, or device name.
What 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.