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.
Bacteriophage And Controls, B. Anthracis Lysis
Microbiology
The Bacteriophage and Controls for Bacillus anthracis Lysis is a gamma phage lysis assay intended to identify B. anthracis from non-hemolytic, aerobic gram-positive colonies isolated from sheep blood agar, aiding in the laboratory identification of B. anthracis culture growth through specific bacteriophage lysis. This microbiological diagnostic method exploits the high specificity of gamma phage for anthrax bacilli. It is an FDA Class 2 device regulated under 21 CFR 866.3045 in the Microbiology specialty, with product code NVQ, requiring 510(k) clearance. It is not an implant and does not carry life-sustaining support designation.
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.