# LAS: Drug Specific Control Materials

- Device class: 1; regulation: 21 CFR 862.3280; FDA's rule: 510(k) exempt
- FDA decisions: 83
- 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)
- 1994: 2
- 1995: 1
- 1997: 2
- 1999: 1
- 2003: 2
- 2004: 1
- 2005: 1
- 2006: 1
- 2008: 1
- 2009: 1

## Most-cited predicates
- K040411: Dri Oxycodone Assay (2004), cited by 4
- K970517: Innofluor Topiramate Control Set (1997), cited by 1
- K030616: Cedia Cyclosporine Plus High Range Controls 4 and 5 (2003), cited by 1

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