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.
Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna
Microbiology
The Nucleic Acid Amplification Test for the Quantitation of Epstein-Barr Virus (EBV) DNA is a quantitative viral nucleic acid test intended for prescription use in transplant patient management, detecting EBV DNA using specified specimen processing, amplification, and detection instrumentation. It is used as an aid in managing transplant patients with active EBV infection or those at risk for developing EBV infections, with results interpreted alongside other clinical and laboratory findings. This device is classified as FDA Class 2, meaning it requires 510(k) premarket notification to demonstrate substantial equivalence before marketing. It carries product code QLX, falls under regulation 866.3183, and is reviewed by the Microbiology specialty panel. The device is not an implant, not life-sustaining, and is not GMP exempt.
510(k) Clearances
4 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.