# JPK: Mixture, Hematology Quality Control

- Device class: 2; regulation: 21 CFR 864.8625; FDA's rule: 510(k) exempt
- FDA decisions: 192
- Recalls: 14 (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)
- 2005: 3
- 2006: 6
- 2007: 5
- 2009: 5
- 2010: 4
- 2011: 1
- 2012: 2
- 2013: 1
- 2014: 2
- 2016: 4

## Most-cited predicates
- K912133: PX Coulter (R) Cell Control (1991), cited by 3
- K053362: Cell-Chex Auto (2006), cited by 3
- K904464: CBC-Laser (R) Hematology Control/Multiple-Modified (1990), cited by 2
- K042094: R&D CBC-XE Hematology Control (2004), cited by 2
- K942822: CBC-Line Hematology Linearity Control (1994), cited by 2
- K954137: QBC Centrifugal Hematology Control (1995), cited by 2
- K843962: CBC-PLT-4 Whole Blood Control/Multiple (1984), cited by 2
- K862186: Lyphochek Glycated Hemoglobin/Whole Blood/Lev.I&II (1986), cited by 2
- K060464: Coulter 5C Cell Control (2006), cited by 2
- K000115: Retic Chex Linearity (2000), cited by 2

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