CIX · Class II · 21 CFR 862.1035

FDA Product Code CIX: Bromcresol Green Dye-binding, Albumin

Leading manufacturers include Em Diagnostic Systems, Inc., Abbott Laboratories and Eastman Kodak Company.

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 Oct 16, 2003
ROCHE DIAGNOSTICS COBAS INTEGRA ALBUMIN GEN. 2
K033009
Roche Diagnostics Corp.
Chemistry · 20d
Cleared Jun 12, 1998
ALBG
K981758
Abbott Laboratories
Chemistry · 24d
Cleared May 27, 1998
ALBG
K981468
Abbott Laboratories
Chemistry · 34d
Cleared Dec 17, 1993
EMDS ALBUMIN (ALB) TEST
K935179
Em Diagnostic Systems, Inc.
Chemistry · 52d
Cleared Dec 28, 1992
ALBUMIN TEST
K923959
Em Diagnostic Systems, Inc.
Chemistry · 144d
Cleared Sep 27, 1991
ABBOTT QUICKSTART ALBUMIN TEST (ALBG) ITEM #5A37
K913920
Em Diagnostic Systems, Inc.
Chemistry · 24d
Cleared Aug 26, 1991
KODAK EKTACHEM DT SLIDES (ALB)
K913195
Eastman Kodak Company
Chemistry · 39d
Cleared Jan 25, 1991
SYSTEMATE ALBUMIN (EPOS APPLICATION) #65401
K905660
Em Diagnostic Systems, Inc.
Chemistry · 38d
Cleared Feb 27, 1990
COBAS READY ALBUMIN REAGENT
K896235
Roche Diagnostic Systems, Inc.
Chemistry · 120d
Cleared Aug 21, 1989
ALBUMIN TEST (ALB) ITEM NUMBER: 65401
K893777
Em Diagnostic Systems, Inc.
Chemistry · 91d
Cleared May 05, 1989
IQ ALBUMIN
K891375
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 57d
Cleared Jan 11, 1989
ALBUMIN TEST (ALB) ITEM #65650
K884705
Em Diagnostic Systems, Inc.
Chemistry · 63d
Cleared Oct 29, 1987
EASY-TEST ALBUMIN (ALB), ITEM NO. 19039
K873994
Em Diagnostic Systems, Inc.
Chemistry · 28d
Cleared Dec 31, 1986
EASY-TEST ALBUMIN (ALB), ITEM NO. 67529/93
K864715
Em Diagnostic Systems, Inc.
Chemistry · 28d
Cleared Oct 15, 1985
TDX AMYLASE
K853978
Abbott Laboratories
Chemistry · 19d
Cleared Aug 27, 1984
SYSTEMATE ALBUMIN
K843108
Em Diagnostic Systems, Inc.
Chemistry · 20d
Cleared Aug 03, 1981
KODAK EKTACHEM CLIN. CHEM. SLIDES (ALB)
K812030
Eastman Kodak Company
Chemistry · 14d
Cleared Sep 16, 1980
BECKMAN ASTRA SYSTEMS ALBUMIN CHEMISTRY
K801750
Beckman Instruments, Inc.
Chemistry · 50d
Cleared Sep 13, 1977
MULTISTAT III ALBUMIN TEST
K771475
Instrumentation Laboratory CO
Chemistry · 40d

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 →