# DIF: Drug Mixture Control Materials

- Device class: 1; regulation: 21 CFR 862.3280; FDA's rule: 510(k) exempt
- FDA decisions: 202
- 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)
- 2004: 5
- 2005: 3
- 2006: 4
- 2007: 1
- 2008: 2
- 2010: 1
- 2011: 1
- 2012: 3
- 2013: 2
- 2016: 1

## Most-cited predicates
- K022707: Liquichek Urine Toxicology Control Level S1E, Model 438; Level S2E, Model 439 (2002), cited by 10
- K981590: Liquichek Urine Toxicology Control Level C1, Liquichek Urine Toxicology Control Level C2, Liquichek Urine Toxicology Con (1998), cited by 5
- K970666: Liquicheck Urine Toxicology Negative Control (1997), cited by 3
- K040758: MGC Dau Control Sets: Primary, Clinical and Select (2004), cited by 2
- K935230: Emit Iic Negative Control, Control I and II (1994), cited by 2
- K951135: Multi-Drug Control Set (1995), cited by 2
- K980871: Lyphochek Whole Blood Control (1998), cited by 2
- K072721: Lyphochek Whole Blood Immunosuppressant Control , Abbott Immunosuppressant MCC (2007), cited by 2
- K893682: Kit- Ciba Corning L-TDM I, II, Iii (1989), cited by 1
- K971691: Liquichek Urine Toxicology Control - Level S1, S2, S3 (1997), cited by 1

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