# CGX: Alkaline Picrate, Colorimetry, Creatinine

- Device class: 2; regulation: 21 CFR 862.1225; FDA's rule: 510(k) required
- FDA decisions: 159
- 510(k) review time 2021–2025: median 318 days (middle half 199–520)
- Recalls: 12 (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: 4
- 2009: 1
- 2012: 1
- 2013: 1
- 2014: 2
- 2016: 1
- 2022: 1
- 2024: 2
- 2025: 1
- 2026: 1

## Most-cited predicates
- K951595: Roche Cobas Integra Analyzer, Reagent Cassettes (1995), cited by 32
- K941837: Roche Reagent for Creatinine (1994), cited by 7
- K925668: Creatinine Meth for Use on the Dimension Clin Chem (1992), cited by 2
- K934361: Olympus Creatinine Reagent (1993), cited by 2
- K901229: Chem 1 Clinical Analyzer (Method Urine Creatinine) (1990), cited by 1
- K083809: Creatinine (2009), cited by 1
- K003247: Creatinine (2000), cited by 1
- K161494: Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL) (2016), cited by 1
- K221813: Nova Allegro UACR Assay, Nova Allegro Analyzer (2024), cited by 1
- K061193: Creatinine (2006), cited by 1

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