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 Siemens Healthcare Diagnostics, Inc..
FDA 510(k) Cleared Diazo Colorimetry, Bilirubin Devices (Product Code CIG)
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 Review Time
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 →