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.
Rickettsia Spp. Nucleic Acid Based Detection Assay
Microbiology
The Rickettsia Spp. Nucleic Acid Based Detection Assay is a microbiology in vitro diagnostic device that detects Rickettsia species nucleic acids in specimens from individuals with signs or symptoms of rickettsial infection and epidemiological risk factors consistent with potential exposure, used in conjunction with other diagnostic assays and clinical observations to aid in diagnosis. It is classified as FDA Class II under regulation 21 CFR 866.3316, requiring 510(k) premarket notification clearance and compliance with general and special controls. The product code is PVQ and it falls under the Microbiology medical specialty. It is not flagged as an implant or life-sustaining device.
510(k) Clearances
1 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.