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.
Material, Quality Control, Semen Analysis
Hematology
The Semen Analysis Quality Control Material is a device used to determine the accuracy and precision of manual, semiautomated, and automated semen analysis instruments measuring parameters such as pH, sperm concentration, total sperm number, motility, morphology, vitality, and white blood cell count. It serves as a calibration and verification tool to ensure reliable performance of semen analysis systems in clinical laboratories. The device is FDA Class 2, regulated under 21 CFR 864.8625 in the Hematology specialty, with product code NRF, and is exempt from premarket notification under submission type 4. It is not an implant and does not provide life-sustaining support.
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.