# JJW: Urinalysis Controls (Assayed And Unassayed)

- Device class: 1; regulation: 21 CFR 862.1660; FDA's rule: 510(k) exempt
- FDA decisions: 61
- Recalls: 14 (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)
- 2002: 3
- 2003: 2
- 2004: 1
- 2005: 2
- 2007: 2
- 2009: 1
- 2011: 2
- 2014: 1
- 2015: 1
- 2017: 1

## Most-cited predicates
- K031231: Liquicheck Urinalysis Control Bilevel, Model 435, Liquichek Urinalysis Control Level 2, Model 436, Liquichek Urinalysis (2003), cited by 3
- K890577: Kenlor Liquid Urine Control (1989), cited by 2
- K023928: Mas UA Control Liquid Assayed Urinalysis Control, Dade Assayed Urinalysis Control (2002), cited by 2
- K070848: Liquichek Urinalysis Control (BI-Level), Control LEVEL1, Level 2,Minipak, 435,436,437,435X (2007), cited by 2
- K880495: Lyphochek Quantitative Urine Control Abnormal (2) (1988), cited by 1
- K103387: Mission Liquid Urine Control, Mission Liquid Diptube Urine Control, Mission Dry Strip Urine Control (2011), cited by 1
- K945913: Irispec Urine Chemistry Control Part a and B (1995), cited by 1
- K043266: Randox Urine Controls (2005), cited by 1
- K981933: Urichemtrak Liquid Assayed Control Levels 1 and 2 (1998), cited by 1
- K935062: Mas Liquid Urinalysis Control (1994), cited by 1

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