FDA Product Code CIG: Diazo Colorimetry, Bilirubin
Bilirubin measurement is essential in neonatal jaundice management and liver disease evaluation. FDA product code CIG covers diazo colorimetric systems for bilirubin quantification.
The diazo reaction produces a colored azobilirubin complex proportional to bilirubin concentration in serum, enabling measurement of total and direct bilirubin for the assessment of jaundice, hepatitis, and biliary obstruction.
CIG devices are Class II medical devices, regulated under 21 CFR 862.1110 and reviewed by the FDA Chemistry panel.
Leading manufacturers include Em Diagnostic Systems, Inc., Abbott Laboratories and Eastman Kodak Company.
235
Total
235
Cleared
71d
Avg days
1976
Since
Declining activity -
1 submissions in the last 2 years
vs 3 in the prior period
Review times increasing: avg
245d
recently vs 71d historically
FDA 510(k) Cleared Diazo Colorimetry, Bilirubin Devices (Product Code CIG)
235 devices
Cleared
Feb 27, 2026
Atellica CH Diazo Total Bilirubin (D_TBil)
Siemens Healthcare Diagnostics, Inc.
Chemistry
245d
Cleared
Jun 12, 2023
Atellica® CH Diazo Direct Bilirubin (D_DBil)
Siemens Healthcare Diagnostics, Inc.
Chemistry
255d
Cleared
Mar 20, 2023
Atellica® CH Diazo Total Bilirubin (D_TBil)
Siemens Healthcare Diagnostics, Inc.
Chemistry
245d
Cleared
Dec 29, 2022
Total Bilirubin2
Abbott Ireland Diagnostics Division
Chemistry
59d
Cleared
Apr 26, 2019
VITROS XT Chemistry Products TBIL-ALKP Slides
Ortho-Clinical Diagnostics, Inc.
Chemistry
28d
Cleared
Apr 02, 2015
Total Bilirubin
Abbott Laboratories
Chemistry
34d
Cleared
Feb 01, 2013
ARCHITECT TOTAL BILIRUBIN
Abbott Laboratories
Chemistry
210d
Cleared
Jun 18, 2010
GEM PREMIER 4000 WITH IQM (ADDITION OF TOTAL BILIRUBIN PARAMETER), GEM CVP 2 (ADDITION OF TOTAL BILIRUBIM ASSIGNMENT TO
Instrumentation Laboratory CO
Chemistry
207d
Cleared
Dec 22, 2006
COBAS INTEGRA BILIRUBIN SPECIAL AND ROCHE/HITACHI BILRUBIN TOTAL, MODELS 20737496 322, 03261638 190, AND 11822713 226
Roche Diagnostics Corp.
Chemistry
28d
Cleared
Aug 29, 2006
DIMENSION VISTA DBIL FLEX REAGENT CARTRIDGE, MODEL K2125
Dade Behring, Inc.
Chemistry
61d
Cleared
Aug 25, 2006
DIMENSION VISTA TBIL FLEX REAGENT CARTRIDGE, AND DIMENSION VISTA TBIL/DBIL CALIBRATOR
Dade Behring, Inc.
Chemistry
67d
Cleared
May 03, 2006
TOTAL BILIRUBIN
Abbott Laboratories
Chemistry
58d
Cleared
Apr 06, 2006
DIMENSION TBI FLEX AND DBI FLEX REAGENT CARTRIDGES AND TBI/DBI CALIBRATOR
Dade Behring, Inc.
Chemistry
28d
Cleared
Sep 13, 2002
TOTAL BILIRUBIN
Abbott Laboratories
Chemistry
57d
Cleared
Sep 06, 2002
DIRECT BILIRUBIN
Abbott Laboratories
Chemistry
65d
Cleared
May 28, 1999
MODIFICATION TO ALCYON DIRECT BILIRUBIN
Abbott Laboratories
Chemistry
60d
Cleared
Sep 16, 1998
TBIL
Abbott Laboratories
Chemistry
8d
Cleared
Jul 22, 1998
DBIL
Abbott Laboratories
Chemistry
49d
Cleared
Jul 07, 1998
ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION LIQUID DIRECT BILIRUBIN REAGENT, CATALOG NUMBER 1877844
Boehringer Mannheim Corp.
Chemistry
39d
Cleared
May 01, 1998
TBIL
Abbott Laboratories
Chemistry
18d
Cleared
Apr 24, 1998
DIRECT BILIRUBIN (DBIL)
Abbott Laboratories
Chemistry
21d
Cleared
Sep 21, 1993
SYSTEMATE DIRECT BILIRUBIN CAT. NO. 65406
Em Diagnostic Systems, Inc.
Chemistry
140d
Cleared
Jul 27, 1993
TOTAL BILIRUBIN
Em Diagnostic Systems, Inc.
Chemistry
103d
Cleared
Sep 09, 1992
SYSTEMATE DIRECT BILIRUBIN TEST TECHNICON RA 1000
Em Diagnostic Systems, Inc.
Chemistry
86d
About Product Code CIG - Regulatory Context
510(k) Submission Activity
235 total 510(k) submissions under product code CIG since 1976, with 235 receiving FDA clearance (average review time: 71 days).
Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 3 in the prior period.
FDA 510(k) Review Time - CIG Product Code
Recent submissions under CIG have taken an average of 245 days to reach a decision - up from 71 days historically. Manufacturers should account for longer review timelines in current project planning.
CIG devices are reviewed by the Chemistry panel. Browse all Chemistry devices →