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.
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Describe your device and the Research Assistant searches 510(k)s, compares intended use, and drafts a predicate shortlist — with citations.
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Thyroglobulin, Antigen, Antiserum, Control
Immunology
This is an immunological reagent kit for detecting and measuring thyroglobulin, the large glycoprotein produced by thyroid follicular cells that serves as a precursor for thyroid hormone synthesis and as a tumor marker in differentiated thyroid cancer monitoring. The kit includes antigen, antiserum, and control components for clinical laboratory immunoassays. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is eligible for third-party review. The product code is DDC, regulated under 21 CFR 866.5870, within the Immunology specialty.
510(k) Clearances
13 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.