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.
General Purpose Reagent
Pathology
The General Purpose Reagent is a chemical reagent with general laboratory application used to collect, prepare, and examine specimens from the human body for diagnostic purposes, not labeled for a specific diagnostic application. It may be an individual substance or multiple substances that, when combined with an analyte-specific reagent (ASR) and other reagents, form part of an in vitro diagnostic (IVD) test system. It is classified as FDA Class 1 (Pathology specialty) under 21 CFR 864.4010, subject to general controls and exempt from Good Manufacturing Practice (GMP) requirements. Product code PPM; not an implant and not life-sustaining.
510(k) Clearances
16 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.