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.
Automated Occult Blood Analyzer
Hematology
The Automated Occult Blood Analyzer (product code OOX) is a Class 2 hematology device regulated under 21 CFR 864.6550 in the Hematology specialty (HE), cleared via 510(k). It is an automated test system intended for the qualitative detection of fecal occult blood in feces by professional laboratories, used for the determination of gastrointestinal bleeding as part of colorectal cancer screening or GI evaluation. The device is eligible for third-party review and is not an implant or life-sustaining device.
510(k) Clearances
6 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.