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., Abbott Laboratories and Beckman Coulter, Inc..
159
Total
159
Cleared
72d
Avg days
1977
Since
Growing category -
4 submissions in the last 2 years
vs 0 in the prior period
Review times increasing: avg
346d
recently vs 65d historically
FDA 510(k) Cleared Alkaline Picrate, Colorimetry, Creatinine Devices (Product Code CGX)
159 devices
Cleared
Jan 09, 2026
Nova Allegro UACR Assay, Nova Allegro Analyzer
Nova Biomedical Corporation
Chemistry
179d
Cleared
Nov 26, 2025
Tru Kidney Health Test Panel
Truvian Health
Chemistry
236d
Cleared
Dec 04, 2024
Atellica® CH Creatinine_3 (Crea3)
Siemens Healthcare Diagnostics, Inc.
Chemistry
89d
Cleared
Nov 19, 2024
Nova Allegro UACR Assay, Nova Allegro Analyzer
Nova Biomedical Corporation
Chemistry
881d
Cleared
Mar 22, 2022
Creatinine2
Abbott Ireland Diagnostics Division
Chemistry
399d
Cleared
Apr 07, 2009
CREATININE
Abbott Laboratories
Chemistry
106d
Cleared
Jun 01, 2007
SYNCHRON LX20 CLINICAL SYSTEMS, CREATININE TEST SYSTEMS
Beckman Coulter, Inc.
Chemistry
25d
Cleared
Jun 01, 2007
SYNCHRON CX DELTA CLINICAL SYSTEMS, CREATININE TEST SYSTEMS
Beckman Coulter, Inc.
Chemistry
25d
Cleared
Jun 01, 2007
SYNCHRON SYSTEMS CREATININE REAGENT
Beckman Coulter, Inc.
Chemistry
25d
Cleared
Apr 28, 2006
SYNCHRON SYSTEMS CREATININE (CREA) REAGENT
Beckman Coulter, Inc.
Chemistry
23d
Cleared
Jul 22, 1998
CREA
Abbott Laboratories
Chemistry
62d
Cleared
May 29, 1998
CREATININE (CREA)
Abbott Laboratories
Chemistry
53d
Cleared
Sep 08, 1995
ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES
Roche Diagnostic Systems, Inc.
Chemistry
155d
Cleared
Aug 26, 1994
ROCHE REAGENT FOR CREATININE
Roche Diagnostic Systems, Inc.
Chemistry
135d
Cleared
Mar 21, 1994
KODAK EKTACHEM DT SLIDES (URCR)
Eastman Kodak Company
Chemistry
213d
Cleared
Oct 18, 1993
SIGMA CRE REAGENT
Sigma Chemical Co.
Chemistry
81d
Cleared
Jul 09, 1993
SYSTEMATE CREATININE TEST ITEM NUMBER 65413
Em Diagnostic Systems, Inc.
Chemistry
66d
Cleared
Dec 28, 1992
CREATININE METH FOR USE ON THE DIMENSION CLIN CHEM
E.I. Dupont DE Nemours & Co., Inc.
Chemistry
48d
Cleared
Oct 15, 1992
CREATININE-IP TEST, # 42375/93, 42323/R1, 42323/R2
Em Diagnostic Systems, Inc.
Chemistry
34d
Cleared
Sep 09, 1992
SYSTEMATE CREATININE TEST
Em Diagnostic Systems, Inc.
Chemistry
76d
Cleared
Dec 18, 1991
SYNCHRON CREATININE TRIGGERED TEST CX4,5,7,
Beckman Instruments, Inc.
Chemistry
40d
Cleared
Sep 18, 1991
ABBOTT QUICKSTART CREATININE TEST(CREA) ITEM# 5A28
Em Diagnostic Systems, Inc.
Chemistry
30d
Cleared
May 08, 1991
SYSTEMATE CREATININE (EPOS APPLICATION) #65413
Em Diagnostic Systems, Inc.
Chemistry
141d
Cleared
Sep 07, 1990
ROCHE COBAS READY CREATININE REAGENT
Roche Diagnostic Systems, Inc.
Chemistry
88d
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 510(k) Review Time - CGX Product Code
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 →