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.
Immunoglobulin M Lambda Heavy And Light Chain Combined
Immunology
The Immunoglobulin M Lambda Heavy and Light Chain Combined assay is an immunology in vitro diagnostic device intended for the in vitro quantification of IgM lambda concentration in human serum, with results to be used in conjunction with previous test results and clinical information. It falls under the Immunology medical specialty and is classified as a Class 2 device under regulation 866.5510, requiring 510(k) premarket notification. These assays support diagnosis and monitoring of monoclonal IgM disorders. It is not an implant and is not life-sustaining.
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What 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.