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.
For Export Only - Antigen, Anti-Cardiac, Indirect Fluorescent Antibody Test System
Unknown
The Anti-Cardiac Antigen Indirect Fluorescent Antibody Test System (For Export Only) is a diagnostic device intended for the detection of anti-cardiac antibodies using indirect immunofluorescence methodology. This product is designated for export only and is not classified for distribution in the United States. The product code is NUK, reviewed by the Clinical Chemistry panel, and carries an FDA Not Classified (N) designation with unclassified reason code 3 indicating export-only status. No regulation number is assigned, and the device carries no implant or life-sustaining support flags.
No 510(k) clearances found for "NUK". Try a different K-number, product code, or device name.
What 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.