# LCO: Platelet Factor 4 Radioimmunoassay

- Device class: 2; regulation: 21 CFR 864.7695; FDA's rule: 510(k) required
- FDA decisions: 13
- 510(k) review time 2021–2025: median 90 days (middle half 90–90)
- Recalls: 7 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1989: 1
- 1999: 1
- 2001: 1
- 2004: 1
- 2006: 1
- 2007: 2
- 2016: 1
- 2017: 1
- 2020: 2
- 2025: 1

## Most-cited predicates
- K053559: PF4 Enhanced Solid Phase Elisa (2006), cited by 3
- K983379: Gti-PF4 Elisa (1999), cited by 3
- K003767: Asserachrom Hpia Test Kit (2001), cited by 2
- K071255: Zymutest Hia Iggam, Zymutest Igg, Model RK040D, RK040A (2007), cited by 1
- K071781: PF4 IGG (2007), cited by 1
- K170854: HemosIL AcuStar HIT-IgG (PF4-H), HemosIL AcuStar HIT Controls (2017), cited by 1

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