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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Immunoglobulin A Kappa Heavy & Light Chain Combined
Immunology
The Immunoglobulin A Kappa Heavy & Light Chain Combined is an in vitro diagnostic reagent used for the quantitative measurement of IgA kappa immunoglobulin concentration in human serum. It is intended for use in patients with previously diagnosed IgA multiple myeloma, used in conjunction with other clinical and laboratory findings to monitor the disease. This device 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 OPX under regulation 866.5510, within the Immunology medical specialty. It is eligible for third-party 510(k) review and carries no implant or life-sustaining flags.
510(k) Clearances
3 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.