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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Multiplex Flow Immunoassay, T. Gondii, Rubella And Cmv
Microbiology
The Multiplex Flow Immunoassay for T. Gondii, Rubella, and CMV (product code OMI) is a Class 2 in vitro diagnostic device regulated under 21 CFR 866.3510 in the Microbiology specialty (MI), cleared via 510(k). It is intended for the quantitative detection of IgG antibodies to Toxoplasma gondii and Rubella, and the qualitative detection of CMV IgG in human serum or plasma, to aid in determining serological status to these pathogens; it is not intended for screening blood or plasma donors. The device is not an implant or life-sustaining.
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.