# JHS: Differential Rate Kinetic Method, Cpk Or Isoenzymes

- Device class: 2; regulation: 21 CFR 862.1215; FDA's rule: 510(k) required
- FDA decisions: 38
- 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)
- 1990: 2
- 1994: 3
- 1995: 1
- 1996: 1
- 1998: 1
- 1999: 2
- 2006: 1
- 2008: 1
- 2011: 1
- 2016: 1

## Most-cited predicates
- K062128: The Dimension Vista Flex Reagent Cartridges / Kit Assays (2006), cited by 1
- K943024: Kinase Isoenzyme (1994), cited by 1
- K903025: Roche Isomune- CK (1990), cited by 1
- K941584: Creatine Kinase Method (1994), cited by 1

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