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, Siemens Healthcare Diagnostics, Inc. and Truvian Health.
FDA 510(k) Cleared Alkaline Picrate, Colorimetry, Creatinine Devices (Product Code CGX)
About Product Code CGX - Regulatory Context
510(k) Submission Activity
159 total 510(k) submissions under product code CGX since 1977, with 159 receiving FDA clearance (average review time: 72 days).
Submission volume has increased in recent years - 4 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under CGX have taken an average of 346 days to reach a decision - up from 65 days historically. Manufacturers should account for longer review timelines in current project planning.
CGX devices are reviewed by the Chemistry panel. Browse all Chemistry devices →