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.
Sirolimus Test System
Clinical Toxicology
The Sirolimus Test System is an in vitro diagnostic device intended for the quantitative measurement of sirolimus (rapamycin) concentrations in whole blood, used as an aid in the management of transplant patients taking this immunosuppressant drug. Therapeutic drug monitoring of sirolimus helps clinicians ensure appropriate dosing to prevent organ rejection while minimizing toxicity. This is an FDA Class 2 device regulated under 21 CFR 862.3840 in the Clinical Toxicology specialty, with product code NRP, requiring 510(k) clearance. The device is eligible for third-party review. It is not an implant and does not provide life-sustaining support.
510(k) Clearances
5 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.