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.
Giardia Spp.
Microbiology
The Giardia Spp. device is an in vitro diagnostic test used to detect Giardia species, intestinal parasites responsible for giardiasis, a common waterborne diarrheal illness, in stool or other biological specimens. It is classified as a Class 2 device under 21 CFR 866.3220, which covers serological reagents, and requires 510(k) premarket notification to demonstrate substantial equivalence to a predicate device. The device falls under the Microbiology medical specialty and is subject to general controls and special controls. It carries no implant or life-sustaining flags.
510(k) Clearances
27 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.