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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Autoantibodies, Glutamic Acid Decarboxylase (Gad)
Immunology
The Autoantibodies, Glutamic Acid Decarboxylase (GAD) device is an in vitro diagnostic immunoassay used for the semi-quantitative determination of glutamic acid decarboxylase (GAD) autoantibodies in human serum, serving as an aid in the diagnosis of Type 1 diabetes mellitus (autoimmune-mediated diabetes). It falls under FDA Class 2, meaning it requires a 510(k) premarket notification to demonstrate substantial equivalence to a legally marketed predicate device. The product code is NWG, regulated under 21 CFR 866.5660, and falls within the Immunology medical specialty. Third-party 510(k) review is available for this device type.
510(k) Clearances
2 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.