# LEG: Enzyme Immunoassay, Valproic Acid

- Device class: 2; regulation: 21 CFR 862.3645; FDA's rule: 510(k) required
- FDA decisions: 35
- Recalls: 7 (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)
- 1997: 2
- 1998: 1
- 2000: 2
- 2001: 1
- 2002: 1
- 2003: 3
- 2004: 1
- 2005: 1
- 2006: 1
- 2009: 1

## Most-cited predicates
- K042476: Vitros Chemistry Products Valp Reagent; Vitro Chemistry Products Calibrator Kit 12; Vitros Chemistry Products TDM Perfos (2004), cited by 3
- K941615: Axsym Valproic Acid (1994), cited by 3
- K930734: Cedia Valporic Acid Assay (1993), cited by 2
- K961256: Synchron Systems Valproic Acid (Vpa) Reagent (1996), cited by 1
- K002551: Emit 2000 Valproic Acid Assay, Emit 2000 Valproic Acid Calibrators, Model 4G019UL, 4G109UL (2000), cited by 1
- K961988: Valproic Acid Eia Test (1996), cited by 1
- K925003: Cobas-FP Reagent for Valproic Acid and Calibrators (1992), cited by 1
- K982880: Dimension (R) Valproic (Valp) Acid Method (1998), cited by 1

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