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.
Let the assistant find your predicates
Describe your device and the Research Assistant searches 510(k)s, compares intended use, and drafts a predicate shortlist — with citations.
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Instrumentation For Clinical Multiplex Test Systems
Clinical Chemistry
The Instrumentation for Clinical Multiplex Test Systems is a device designed to measure and sort multiple signals generated by clinical assays from a single sample, using fluorescence, luminescence, or other physical and chemical properties. The system may integrate scanning, reagent handling, hybridization, washing, instrument control, and data acquisition components, and is used together with specific assays to measure multiple analytes of a similar chemical nature. It is an FDA Class 2 device regulated under 21 CFR 862.2570 in the Clinical Chemistry specialty, with product code NSU, and is exempt from premarket notification under submission type 4. It is not an implant and does not carry life-sustaining support designation.
510(k) Clearances
13 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.