# DLJ: Calibrators, Drug Specific

- Device class: 2; regulation: 21 CFR 862.3200; FDA's rule: 510(k) exempt
- FDA decisions: 123
- Recalls: 3 (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)
- 1999: 2
- 2001: 2
- 2002: 4
- 2003: 3
- 2004: 1
- 2005: 1
- 2006: 5
- 2008: 1
- 2009: 1
- 2013: 1

## Most-cited predicates
- K020769: Single Analyte Urine Drugs of Abuse Calibrators and Controls (2002), cited by 2
- K011112: Cyclosporine Calibrator (2001), cited by 2
- K012109: Dri Ecstasy Urine Calibrators (2001), cited by 2
- K052015: Dimension Extended Range Cyclosporine Calibrator, Catalog # DC108 (2005), cited by 2
- K923386: THC Urine Calibrators (1992), cited by 1
- K060503: Dimension Tacr Calibrator, Model DC107 (2006), cited by 1
- K021449: Cannabinoid Urine Drugs of Abuse Calibrators and Controls (2002), cited by 1
- K061503: Dimension Cyclosporine Extended Range Calibrator (DC108A) (2006), cited by 1
- K053108: Dimension Csae Cyclosporine Extended Range Calibrator, Model DC108 (2006), cited by 1
- K961726: Abuscreen Online Cannabinoids Calibration Pack 20 (1996), cited by 1

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