# CIX: Bromcresol Green Dye-Binding, Albumin

- Device class: 2; regulation: 21 CFR 862.1035; FDA's rule: 510(k) required
- FDA decisions: 120
- 510(k) review time 2021–2025: median 460 days (middle half 422–498)
- Recalls: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2007: 1
- 2008: 1
- 2009: 1
- 2011: 3
- 2012: 1
- 2013: 1
- 2018: 1
- 2019: 1
- 2021: 2
- 2026: 1

## Most-cited predicates
- K991576: Additional Assays for the Bayer Advia 1650 Chemistry System (1999), cited by 12
- K981758: ALBG (1998), cited by 1
- K896235: Cobas Ready Albumin Reagent (1990), cited by 1
- K812030: Kodak Ektachem Clin. Chem. Slides (Alb) (1981), cited by 1
- K200898: Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon Hellas Urea Nitrogen, Medicon Hellas Glucose, Medicon Hellas Total Bilirubin, Medicon Hellas Direct Bilirubin (2021), cited by 1
- K022072: Precision Systems Analette Chemistry Analyzer & Medical Analysis Systems Reagents (2002), cited by 1
- K023875: Vitros Chemistry Products Alb Slide, Vitros Chemistry Products Calibrator Kit 4 (2002), cited by 1
- K924368: Olympus Albumin Reagent (1993), cited by 1
- K113374: Ace Albumin Reagent Ace Total Protein Reagent Ace Calcium-Arsenazo Reagent Ace Phosphorus U.V. Reagent (2012), cited by 1
- K992399: Additional Ims Assays for the Bayer Advia Ims System (1999), cited by 1

Source page: https://510kreport.com/product-code/CIX
Data by year (CSV): https://510kreport.com/product-code/CIX.csv