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.
Test, Epithelial Ovarian Tumor Associated Antigen (He4)
Immunology
The Test, Epithelial Ovarian Tumor Associated Antigen (HE4) is an enzyme immunometric assay for the quantitative measurement of HE4 (human epididymis protein 4) in human serum, intended as an aid in monitoring recurrence or progressive disease in patients with epithelial ovarian cancer, used in conjunction with other clinical monitoring methods. Classified as FDA Class 2 under regulation 21 CFR 866.6010 within the Immunology medical specialty, it requires a 510(k) premarket notification and is eligible for third-party review; it is not intended to assess initial risk or diagnose new disease. The product code is OIU. It is not flagged as an implant or life-sustaining device.
510(k) Clearances
5 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.