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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Joint Biological Agent Identification And Diagnostic System (Jbaids) Tularemia Detection Kit
Microbiology
The Joint Biological Agent Identification and Diagnostic System (JBAIDS) Tularemia Detection Kit (product code OEH) is a microbiology in vitro diagnostic device used to aid in the diagnosis of pneumonic or typhoidal tularemia by performing qualitative PCR-based detection of target DNA sequences of Francisella tularensis in specimens from individuals presenting with signs and symptoms of infection. Tularemia is a potentially serious infectious disease caused by a Tier 1 select agent. This device is FDA Class 2 under regulation 866.3280 in the Microbiology specialty, requiring 510(k) clearance and compliance with general and special controls. It carries no implant or life-sustaining flags.
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.