FDA Product Code CGX: Alkaline Picrate, Colorimetry, Creatinine
FDA product code CGX covers alkaline picrate colorimetric systems for creatinine measurement used in clinical chemistry laboratories.
The Jaffe reaction uses alkaline picrate to form a colored complex with creatinine in serum or urine, enabling quantification of this kidney function marker. Creatinine measurement is a cornerstone of renal function assessment and glomerular filtration rate estimation.
CGX devices are Class II medical devices, regulated under 21 CFR 862.1225 and reviewed by the FDA Chemistry panel.
Leading manufacturers include Nova Biomedical Corporation and Siemens Healthcare Diagnostics, Inc..
List of Alkaline Picrate, Colorimetry, Creatinine devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Alkaline Picrate, Colorimetry, Creatinine devices (product code CGX). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Chemistry FDA review panel. Browse all Chemistry devices →