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.
Immunochemical, Thyroglobulin Autoantibody
Immunology
The Immunochemical, Thyroglobulin Autoantibody test is an in vitro diagnostic device used in immunology to detect and measure autoantibodies against thyroglobulin, a protein involved in thyroid hormone synthesis, in patient serum. Detection of these autoantibodies aids in the diagnosis and monitoring of autoimmune thyroid diseases such as Hashimoto's thyroiditis and Graves' disease. This device is FDA Class 2, a moderate risk designation that requires 510(k) premarket notification to demonstrate substantial equivalence before marketing. It carries product code JNL and is regulated under 21 CFR 866.5870, within the Immunology medical specialty. This device is eligible for third-party 510(k) review.
510(k) Clearances
21 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.