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.
25-Oh-Vitamin D Mass Spectrometry Test System
Clinical Chemistry
The 25-OH-Vitamin D Mass Spectrometry Test System is an in vitro diagnostic device intended for the quantitative determination of total 25-hydroxyvitamin D (25-OH-D) in patient specimens using mass spectrometry, used to assess vitamin D status in clinical practice. It is classified as FDA Class 2 under 21 CFR 862.1840 in the Clinical Chemistry specialty, and is exempt from 510(k) premarket notification requirements. Product code PSL; not an implant and not life-sustaining.
510(k) Clearances
1 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.