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.
Lateral Flow Immunochromatography Assay For Host Infection Biomarkers
Microbiology
The Lateral Flow Immunochromatography Assay For Host Infection Biomarkers is an in vitro diagnostic device intended for the detection and qualitative or quantitative measurement of one or more non-microbial analytes in human clinical specimens to aid in the assessment and identification of a localized microbial infection when used in conjunction with clinical signs and symptoms and other clinical and laboratory findings. It is classified as FDA Class 2, requiring 510(k) premarket notification under regulation 866.3230 in the Microbiology specialty. The product code is QGN. It is not an implant and is not life-sustaining.
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.