CIX · Class II · 21 CFR 862.1035

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
1–24 of 120
Cleared Jan 09, 2026
Core Metabolic
K251157
Truvian Health
Chemistry · 269d
Cleared Nov 23, 2021
Albumin BCG2
K203248
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
K200898
Medicon Hellas S.A
Chemistry · 536d
Cleared Jun 07, 2019
VITROS XT Chemistry Products ALB-TP Slides
K191316
Ortho-Clinical Diagnostics, Inc.
Chemistry · 23d
Cleared Apr 13, 2018
ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400
K170901
Biosystems S.A.
Chemistry · 382d
Cleared Apr 04, 2011
EASYRA ALBUMIN, CALCIUM, MAGNESIUM AND INORGANIC PHOSPHOROUS REAGENT
K101088
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
K080874
Medica Corp.
Chemistry · 326d
Cleared Oct 16, 2003
ROCHE DIAGNOSTICS COBAS INTEGRA ALBUMIN GEN. 2
K033009
Roche Diagnostics Corp.
Chemistry · 20d
Cleared Dec 10, 2002
VITROS CHEMISTRY PRODUCTS ALB SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 4
K023875
Ortho-Clinical Diagnostics, Inc.
Chemistry · 19d
Cleared Jun 25, 2001
OLYMPUS AU5400 CLINICAL CHEMISTRY ANALYZER
K011720
Olympus America, Inc.
Chemistry · 21d
Cleared Sep 15, 1999
ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM
K992399
Bayer Corp.
Chemistry · 58d
Cleared Jun 30, 1999
ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM
K991576
Bayer Corp.
Chemistry · 55d
Cleared Mar 23, 1999
RANDOX ALBUMIN
K984494
Randox Laboratories, Ltd.
Chemistry · 96d
Cleared Jun 12, 1998
ALBG
K981758
Abbott Laboratories
Chemistry · 24d
Cleared May 27, 1998
ALBG
K981468
Abbott Laboratories
Chemistry · 34d
Cleared Oct 13, 1995
TRACE COBAS MIRA RANGE
K952488
Trace Scientific , Ltd.
Chemistry · 136d
Cleared Mar 01, 1995
DMA ALBUMIN PROCEDURE
K946355
Data Medical Associates, Inc.
Chemistry · 61d
Cleared Dec 17, 1993
EMDS ALBUMIN (ALB) TEST
K935179
Em Diagnostic Systems, Inc.
Chemistry · 52d
Cleared Feb 08, 1993
OLYMPUS ALBUMIN REAGENT
K924368
Olympus Corp.
Chemistry · 164d
Cleared Dec 28, 1992
ALBUMIN TEST
K923959
Em Diagnostic Systems, Inc.
Chemistry · 144d
Cleared Sep 11, 1992
TRACE ALBUMIN-MR REAGENT
K923322
Trace Scientific , Ltd.
Hematology · 66d
Cleared Jul 17, 1992
OLYMPUS ALBUMIN REAGENT
K922369
Olympus Corp.
Chemistry · 58d
Cleared Nov 27, 1991
TECHNICON CHEM 1(TM) SYST (GEN2 SYST)
K914888
Technicon Instruments Corp.
Chemistry · 28d
Cleared Sep 27, 1991
ABBOTT QUICKSTART ALBUMIN TEST (ALBG) ITEM #5A37
K913920
Em Diagnostic Systems, Inc.
Chemistry · 24d

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 →