# DKB: Calibrators, Drug Mixture

- Device class: 2; regulation: 21 CFR 862.3200; FDA's rule: 510(k) exempt
- FDA decisions: 94
- Recalls: 8 (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)
- 2001: 1
- 2002: 2
- 2003: 4
- 2004: 1
- 2005: 1
- 2006: 3
- 2009: 2
- 2011: 2
- 2012: 1
- 2014: 2

## Most-cited predicates
- K051088: Multiple Analyte Urine Drugs of Abuse Calibrators and Controls (2005), cited by 6
- K983159: Drugs of Abuse Urine Calibrators and Controls (1998), cited by 4
- K033306: Preciset Dat Plus II and Cfas Dat Qualitative Plus Calibrators (2003), cited by 2
- K980853: Cedia Dau Multi-Drug Calibrators (1998), cited by 2
- K993755: Emit Calibrater/Control Level 0, Level 1, Level 2, Level 3, Level 4, Level 5 (1999), cited by 2
- K983747: Synchron Systems Dat Low and High Urine Calibrators II (1998), cited by 2
- K031775: Preciset Dat Plus I Calibrators (2003), cited by 2
- K935101: Urine Calibrators and Controls Modification (1994), cited by 2
- K962817: Drug Calibrator II (1996), cited by 1
- K912729: Emit Calibrator B Level 1(Cutoff) & Level 2(High) (1991), cited by 1

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