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.
Fluorescent Immunoassay, Theophylline
Clinical Toxicology
The Fluorescent Immunoassay for Theophylline is a laboratory diagnostic test used to quantitatively measure theophylline levels in patient specimens, supporting therapeutic drug monitoring for conditions such as asthma and chronic obstructive pulmonary disease. The device is FDA Class 2, indicating moderate risk; it requires 510(k) premarket notification to demonstrate substantial equivalence to a legally marketed predicate device. It carries product code LER and is regulated under 21 CFR 862.3880 in the Clinical Toxicology specialty. This device is eligible for third-party review under FDA's accredited persons program.
510(k) Clearances
15 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.