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.
Enzyme Immunoassay, Methotrexate
Unknown
Enzyme immunoassay for methotrexate is a laboratory test method used to measure serum levels of methotrexate, a chemotherapy and immunosuppressive agent requiring careful monitoring due to its narrow therapeutic window. This device is currently unclassified by the FDA, meaning it has not been assigned to Class 1, 2, or 3 and its regulatory pathway has not been fully determined. The product code is LAO, with no regulation number assigned and no medical specialty designation recorded. No special flags such as implant, life sustaining, or third-party review eligibility apply.
510(k) Clearances
10 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.