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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Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates
Microbiology
The Phenotypic Test Kit for Non-Susceptible/Elevated MIC Organisms (Cultured Isolates) is a microbiological diagnostic device used for the qualitative detection of carbapenemase enzymes in pure colonies of Enterobacteriaceae and Pseudomonas aeruginosa that have elevated MIC values to any carbapenem antibiotic. This test aids clinical laboratories in identifying organisms with carbapenem resistance mechanisms, which is critical for infection control and guiding antibiotic therapy decisions. It is classified as FDA Class II under regulation 21 CFR 866.1640, meaning it requires premarket notification (510(k)) clearance and must comply with general and special controls. The product code is PTJ and it falls under the Microbiology medical specialty. It is not flagged as an implant or life-sustaining device.
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.