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.
Autoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 230
Immunology
The Skin Autoantibody Test for Bullous Pemphigoid (BP180 and BP230) (product code OEG) is an immunology in vitro diagnostic device used as an aid in the diagnosis of bullous pemphigoid, an autoimmune blistering skin disease, by detecting autoantibodies against bullous pemphigoid antigens 180 (BP180) and 230 (BP230) in patient samples. This device is FDA Class 2 under regulation 866.5660 in the Immunology specialty, requires 510(k) clearance, and is eligible for third-party review. It carries no implant or life-sustaining flags.
510(k) Clearances
3 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.