CGX · Class II · 21 CFR 862.1225

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.

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
1–24 of 159
Cleared Jan 09, 2026
Nova Allegro UACR Assay, Nova Allegro Analyzer
K252206
Nova Biomedical Corporation
Chemistry · 179d
Cleared Nov 26, 2025
Tru Kidney Health Test Panel
K251058
Truvian Health
Chemistry · 236d
Cleared Dec 04, 2024
Atellica® CH Creatinine_3 (Crea3)
K242685
Siemens Healthcare Diagnostics, Inc.
Chemistry · 89d
Cleared Nov 19, 2024
Nova Allegro UACR Assay, Nova Allegro Analyzer
K221813
Nova Biomedical Corporation
Chemistry · 881d
Cleared Mar 22, 2022
Creatinine2
K210452
Abbott Ireland Diagnostics Division
Chemistry · 399d
Cleared Nov 15, 2016
Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL)
K161494
Siemens Healthcare Diagnostics, Inc.
Chemistry · 167d
Cleared Jan 27, 2014
DIMENSION CREATININE (CRE2) FLEX REAGENT CARTRIDGE
K132638
Siemens Healthcare Diagnostics, Inc.
Chemistry · 157d
Cleared Jan 24, 2014
DIMENSION VISTA CREATININE (CRE2) FLEX REAGENT CARTRIDGE
K133728
Siemens Healthcare Diagnostics, Inc.
Chemistry · 49d
Cleared Apr 07, 2009
CREATININE
K083809
Abbott Laboratories
Chemistry · 106d
Cleared Jun 01, 2007
SYNCHRON LX20 CLINICAL SYSTEMS, CREATININE TEST SYSTEMS
K071277
Beckman Coulter, Inc.
Chemistry · 25d
Cleared Jun 01, 2007
SYNCHRON CX DELTA CLINICAL SYSTEMS, CREATININE TEST SYSTEMS
K071280
Beckman Coulter, Inc.
Chemistry · 25d
Cleared Jun 01, 2007
SYNCHRON SYSTEMS CREATININE REAGENT
K071283
Beckman Coulter, Inc.
Chemistry · 25d
Cleared Apr 28, 2006
SYNCHRON SYSTEMS CREATININE (CREA) REAGENT
K060935
Beckman Coulter, Inc.
Chemistry · 23d
Cleared Jun 21, 2000
VITROS CHEMISTRY PRODUCTS CREA DT SLIDES
K001769
Ortho-Clinical Diagnostics
Chemistry · 9d
Cleared Feb 18, 2000
CREATININE-S ASSAY, MODEL 221-30, 221-50, 221-17
K000055
Diagnostic Chemicals , Ltd.
Chemistry · 42d
Cleared Jul 22, 1998
CREA
K981799
Abbott Laboratories
Chemistry · 62d
Cleared May 29, 1998
CREATININE (CREA)
K981240
Abbott Laboratories
Chemistry · 53d
Cleared Mar 06, 1998
RANDOX CREATININE
K973993
Randox Laboratories, Ltd.
Chemistry · 136d
Cleared Sep 22, 1997
SIGMA DIAGNOSTICS CREATININE REAGENT, SIGMA DIAGNOSTICS CREATININE REAGENT
K972743
Sigma Diagnostics, Inc.
Chemistry · 61d
Cleared Sep 30, 1996
SIGMA DIAGNOSTICS CREATININE REAGENT KIT
K963534
Sigma Diagnostics, Inc.
Chemistry · 26d
Cleared Sep 08, 1995
ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES
K951595
Roche Diagnostic Systems, Inc.
Chemistry · 155d
Cleared Sep 20, 1994
CREATININE-PO REAGENT KIT
K943924
Synermed, Inc.
Chemistry · 39d
Cleared Aug 26, 1994
ROCHE REAGENT FOR CREATININE
K941837
Roche Diagnostic Systems, Inc.
Chemistry · 135d
Cleared Mar 21, 1994
KODAK EKTACHEM DT SLIDES (URCR)
K934071
Eastman Kodak Company
Chemistry · 213d

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 →