# JIL: Method, Enzymatic, Glucose (Urinary, Non-Quantitative)

- Device class: 2; regulation: 21 CFR 862.1340; FDA's rule: 510(k) required
- FDA decisions: 81
- 510(k) review time 2021–2025: median 1211 days (middle half 1211–1211)
- Recalls: 6 (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)
- 2009: 1
- 2011: 1
- 2012: 1
- 2014: 1
- 2015: 1
- 2016: 2
- 2017: 1
- 2018: 4
- 2019: 1
- 2023: 1

## Most-cited predicates
- K091216: Clinitek Status+Analyzer and Clinitek Status Connect System, Models 1780, 1797 (2009), cited by 4
- K896454: Chemstrip (R) 10 with SG Urine Test Strips (1990), cited by 3
- K952971: Dia Screen Reagent Strips (1995), cited by 2
- K940043: Bioscan Reagent Strips (1994), cited by 2
- K861255: Behring Rapignost Total Screen L Urine Test Strips (1986), cited by 2
- K961375: Dia Screen 10 Way Reagent Strips (1996), cited by 2
- K940469: Urine Reagent Strip-3 Parameters (1994), cited by 1
- K991927: Medi-Test Combi 11 (1999), cited by 1
- K171083: iChemVELOCITY Automated Urine Chemistry System (2017), cited by 1
- K012397: Urisys 2400 Urine Test Strip (2001), cited by 1

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