# NOE: Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2

- Device class: 2; regulation: 21 CFR 866.5600; FDA's rule: 510(k) required
- FDA decisions: 8
- 510(k) review time 2021–2025: median 290 days (middle half 290–290)
- Recalls: 12 (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)
- 2003: 1
- 2004: 1
- 2005: 1
- 2006: 1
- 2007: 1
- 2011: 1
- 2014: 1
- 2021: 1

## Most-cited predicates
- K062234: Modification to Diadexus Plac Test (2006), cited by 2
- K030477: Diadexus Plac Test (2003), cited by 2
- K050523: Diadexus Plac Test (2005), cited by 1

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