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.
Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness
Microbiology
The Device to Detect and Identify Selected Microbial Agents that Cause Acute Febrile Illness is an in vitro diagnostic device intended to detect and identify microbial agents in human clinical specimens from patients presenting with signs and symptoms of acute febrile illness who are at risk for or have been exposed to specific pathogens. It is intended as an aid in diagnosis in conjunction with clinical, epidemiologic, and laboratory data including travel history and risk factors. This device is classified as FDA Class 2, requiring 510(k) clearance, under regulation 866.3966 in the Microbiology specialty. It carries product code QMV and is not an implant and not life-sustaining.
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.