# JFY: Enzymatic Method, Creatinine

- Device class: 2; regulation: 21 CFR 862.1225; FDA's rule: 510(k) required
- FDA decisions: 49
- 510(k) review time 2021–2025: median 314 days (middle half 223–406)
- Recalls: 9 (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)
- 2008: 4
- 2009: 3
- 2011: 2
- 2014: 2
- 2016: 1
- 2017: 1
- 2018: 2
- 2019: 2
- 2021: 2
- 2026: 1

## Most-cited predicates
- K003261: Creatinine Plus (2000), cited by 6
- K024098: Cobas Integra Creatinine Plus Ver.2 Assay (2002), cited by 5
- K142391: Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips ( Microalbumin/Creatinine ) (2014), cited by 2
- K875191: Kodak Ektachem DT Slides (CRSC) (1988), cited by 2
- K072409: Afinion Acr and Acr Control (2008), cited by 2
- K812095: Enxymatic Creatinine Test (1981), cited by 2
- K070727: Advia Chemistry Enzymatic Creatinine_2 (2007), cited by 2
- K001310: Vitros Chemistry  Products Crea Slide, Virtros Chemistry Products Calibrator Kit 1 (2000), cited by 1
- K110137: Abx Pentra Enzymatic Creatinine CP, Abx Pentra Multical, Abx Pentra N Control, Abx Pentra P Control, and Abx Pentra Urin (2011), cited by 1
- K071216: Vitros Chemistry Products CRSC Slides, Vitros Chemistry Products DT Calibrator Kit, Model 680 2721, 195 7927 (2007), cited by 1

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