FDA Product Code CIX: Bromcresol Green Dye-binding, Albumin
Leading manufacturers include Em Diagnostic Systems, Inc., Harleco and Abbott Laboratories.
120
Total
120
Cleared
74d
Avg days
1976
Since
Growing category -
1 submissions in the last 2 years
vs 0 in the prior period
Review times increasing: avg
269d
recently vs 72d historically
FDA 510(k) Cleared Bromcresol Green Dye-binding, Albumin Devices (Product Code CIX)
120 devices
Cleared
Jan 09, 2026
Core Metabolic
Truvian Health
Chemistry
269d
Cleared
Nov 23, 2021
Albumin BCG2
Abbott Ireland Diagnostics Division
Chemistry
384d
Cleared
Sep 21, 2021
Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon Hellas Urea Nitrogen, Medicon Hellas Glucose, Medicon Hellas Total Bilirubin, Medicon Hellas Direct Bilirubin
Medicon Hellas S.A
Chemistry
536d
Cleared
Jun 07, 2019
VITROS XT Chemistry Products ALB-TP Slides
Ortho-Clinical Diagnostics, Inc.
Chemistry
23d
Cleared
Apr 13, 2018
ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400
Biosystems S.A.
Chemistry
382d
Cleared
Aug 19, 2013
ACE ALBUMIN REAGENT, ACE TOTAL PROTEIN REAGENT, ACE CALCIUM-ARSENAZO REAGENT AND ACE PHOSPHORUS REAGENT
Alfa Wassermann Diagnostics Technologies, LLC
Chemistry
88d
Cleared
Jul 13, 2012
ACE ALBUMIN REAGENT ACE TOTAL PROTEIN REAGENT ACE CALCIUM-ARSENAZO REAGENT ACE PHOSPHORUS U.V. REAGENT
Alfa Wassermann Diagnostic Technologies, Inc.
Chemistry
240d
Cleared
Sep 08, 2011
POLY-CHEM 90 ALBUMIN, BUN, CALCIUM, CARBON DIOXIDE, CREATININE, AND TOTAL PROTEIN TESTS
Polymedco, Inc.
Chemistry
168d
Cleared
Jun 21, 2011
ELITECH CLINICAL SYSTEMS CALCIUM ARSENAZO
Elitechgroup
Chemistry
88d
Cleared
Apr 04, 2011
EASYRA ALBUMIN, CALCIUM, MAGNESIUM AND INORGANIC PHOSPHOROUS REAGENT
Medica Corp.
Chemistry
350d
Cleared
Feb 20, 2009
EASYRA ALB REAGENT AND EASYRA ALP REAGENT, MODEL 10218/10214, EASYRA AST REAGENT, MODEL 10206, EASYRA CO2 REAGENT
Medica Corp.
Chemistry
326d
Cleared
Jul 14, 2008
S40 CLINICAL ANALYZER, S TEST ALB
Alfa Wassermann Diagnostic Technologies, Inc.
Chemistry
347d
Cleared
Jun 05, 2007
ABX PENTRA ALBUMIN CP, ABX PENTRA MICRO-ALBUMIN CP, ABX PENTRA TOTAL PROTEIN CP, ABX PENTRA MULTICAL
Horiba Abx
Chemistry
469d
Cleared
Oct 16, 2003
ROCHE DIAGNOSTICS COBAS INTEGRA ALBUMIN GEN. 2
Roche Diagnostics Corp.
Chemistry
20d
Cleared
Dec 10, 2002
VITROS CHEMISTRY PRODUCTS ALB SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 4
Ortho-Clinical Diagnostics, Inc.
Chemistry
19d
Cleared
Sep 21, 2001
WIENER LAB.ALBUMINA AA, MODELS 6X60 ML CAT N 1690008, 6X120 ML CAT 1009300
Wiener Laboratories Saic
Chemistry
60d
Cleared
Jun 25, 2001
OLYMPUS AU5400 CLINICAL CHEMISTRY ANALYZER
Olympus America, Inc.
Chemistry
21d
Cleared
May 23, 2001
CHEMWELL, MODEL 2900
Awareness Technology, Inc.
Chemistry
61d
Cleared
Dec 05, 2000
ALBUMIN
Jas Diagnostics, Inc.
Chemistry
42d
Cleared
Sep 15, 1999
ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM
Bayer Corp.
Chemistry
58d
Cleared
Jun 30, 1999
ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM
Bayer Corp.
Chemistry
55d
Cleared
Mar 23, 1999
RANDOX ALBUMIN
Randox Laboratories, Ltd.
Chemistry
96d
Cleared
Jun 12, 1998
ALBG
Abbott Laboratories
Chemistry
24d
Cleared
May 27, 1998
ALBG
Abbott Laboratories
Chemistry
34d
About Product Code CIX - Regulatory Context
510(k) Submission Activity
120 total 510(k) submissions under product code CIX since 1976, with 120 receiving FDA clearance (average review time: 74 days).
Submission volume has increased in recent years - 1 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 - CIX Product Code
Recent submissions under CIX have taken an average of 269 days to reach a decision - up from 72 days historically. Manufacturers should account for longer review timelines in current project planning.
CIX devices are reviewed by the Chemistry panel. Browse all Chemistry devices →