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.
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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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Media, Culture, Amino Acid Assay
Microbiology
The Media, Culture, Amino Acid Assay is a microbiology diagnostic culture medium specially formulated to support the microbiological assay of amino acids in biological specimens using auxotrophic microorganisms whose growth is proportional to the concentration of a specific amino acid, used in nutritional and metabolic assessments. This device is FDA Class 1, the lowest risk category, subject only to general controls with no premarket submission required. It carries product code JRZ and is regulated under 21 CFR 866.2350, within the Microbiology medical specialty.
No 510(k) clearances found for "JRZ". Try a different K-number, product code, or device name.
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.