# JIR: Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)

- Device class: 1; regulation: 21 CFR 862.1645; FDA's rule: 510(k) exempt
- FDA decisions: 38
- 510(k) review time 2021–2025: median 444 days (middle half 396–493)
- Recalls: 2 (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)
- 1996: 4
- 1997: 2
- 1998: 2
- 1999: 3
- 2000: 2
- 2002: 1
- 2007: 1
- 2015: 1
- 2022: 1
- 2023: 1

## Most-cited predicates
- K992257: New Multiples Reagent Strips (1999), cited by 4
- K963142: Dca 2000 + Microalbumin/Creatinine Assay (1996), cited by 2
- K934146: N-Assay Tia Microalbumin (1994), cited by 2
- K972337: Dclare Immunodip Stickfor Microalbuminuria (1997), cited by 1
- K210069: Minuteful - kidney test (2022), cited by 1
- K932950: Tina-Quant Microalbumin (1995), cited by 1

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