# LEH: Radioimmunoassay, Vancomycin

- Device class: 2; regulation: 21 CFR 862.3950; FDA's rule: 510(k) required
- FDA decisions: 31
- 510(k) review time 2021–2025: median 361 days (middle half 361–361)
- 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)
- 1998: 1
- 2001: 1
- 2002: 1
- 2003: 1
- 2005: 2
- 2006: 2
- 2008: 1
- 2013: 1
- 2016: 2
- 2023: 1

## Most-cited predicates
- K955851: Axsym Vancomycin II (1996), cited by 4
- K963267: Vancomycin Flex Reagent Cartridge (1996), cited by 2
- K160202: Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL) (2016), cited by 2
- K881040: Emit Vancomycin Assay (1988), cited by 2
- K072036: Architect Ivancomycin Reagents and Architect Ivancomycin Calibrators, Models: 1P30-25 and 1P30-01 (2008), cited by 1
- K020692: Emit 2000 Vancomycin Assay (2002), cited by 1
- K813218: TDX Vancomycin (1981), cited by 1
- K901759: Cobas-FP Reagents for Vancomycin (1990), cited by 1
- K060586: Enzyme Immunoassay, Vancomycin (2006), cited by 1

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