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.
Test, Opiates, Employment And Insurance Testing, Exempt
Clinical Toxicology
The Test, Opiates, Employment And Insurance Testing (Exempt) is a clinical toxicology in vitro diagnostic test for the qualitative analysis of opiates as a class, designed for workplace and insurance drug screening rather than clinical patient management or diagnosis. It is classified as FDA Class II under regulation 21 CFR 862.3650 and has been exempted from 510(k) premarket notification requirements by FDA Federal Register publication (82 FR 31976, July 11, 2017), subject to the limitations in 21 CFR 862.9. The product code is PVH and it falls under the Clinical Toxicology medical specialty. It is not flagged as an implant or life-sustaining device.
No 510(k) clearances found for "PVH". 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.