# CGS: Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes

- Device class: 2; regulation: 21 CFR 862.1215; FDA's rule: 510(k) required
- FDA decisions: 123
- Recalls: 2 (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)
- 2004: 1
- 2006: 1
- 2007: 1
- 2008: 2
- 2009: 1
- 2011: 1
- 2013: 1
- 2016: 1
- 2019: 1
- 2020: 1

## Most-cited predicates
- K834502: CK-Nac Reagent (1984), cited by 4
- K081731: Dimension Cki Flex Reagent Cartridge, Dimension Mbi Flex Reagent Cartridge, and Cki/Mbi Calibrator, Models DF38, DF32 (2008), cited by 2
- K043202: Olympus Creatine Kinase Reagent OSR6179/OSR6279 (2004), cited by 1
- K781719: CPK Reagent Set, Nad Reduction (1978), cited by 1
- K952646: IL Test CK-MB (1995), cited by 1

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