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.
Hemoglobin A1c Test System
Clinical Chemistry
The Hemoglobin A1c Test System is a clinical chemistry in vitro diagnostic device used for the quantitative determination of Hemoglobin A1c (HbA1c) to aid in the diagnosis of diabetes and to monitor long-term glycemic control in diabetic patients. It falls under the Clinical Chemistry medical specialty and is classified as a Class 2 device under regulation 862.1373, requiring 510(k) premarket notification. HbA1c measurement reflects average blood glucose levels over the preceding two to three months. It is not an implant and is not life-sustaining.
510(k) Clearances
24 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.