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.
Bilirubin (Total And Unbound) In The Neonate Test System
Clinical Chemistry
The Bilirubin (Total and Unbound) in the Neonate Test System is a clinical chemistry in vitro diagnostic device used to measure total and unbound bilirubin levels in neonatal blood, enabling the assessment and management of neonatal hyperbilirubinemia (jaundice). Classified as FDA Class 1 under 21 CFR 862.1113 in the Clinical Chemistry specialty, it requires 510(k) notification and is eligible for third-party review. The product code is MQM.
510(k) Clearances
17 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.