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 Em Diagnostic Systems, Inc., Harleco and Abbott Laboratories.