# JIQ: Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)

- Device class: 1; regulation: 21 CFR 862.1645; FDA's rule: 510(k) exempt
- FDA decisions: 13
- Recalls: 1 (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)
- 1984: 1
- 1987: 1
- 1989: 1
- 1990: 2
- 1994: 2
- 1995: 1
- 1997: 2
- 1999: 1
- 2003: 1
- 2014: 1

## Most-cited predicates
- K895883: Beckman MA Microalbumin Reagent Kit (1989), cited by 3
- K903123: Raichem (TM) Spia (TM) Microalbulmin Reagent (1990), cited by 1
- K944664: Wako Micro-Albumin B/Wako Micro Albumin Calibrator (1995), cited by 1
- K935662: Synermed IR 500 Chemistry Analyzer (1994), cited by 1

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