# CDT: Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides

- Device class: 1; regulation: 21 CFR 862.1705; FDA's rule: 510(k) exempt
- FDA decisions: 151
- 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)
- 1999: 1
- 2001: 1
- 2002: 1
- 2004: 1
- 2005: 1
- 2007: 1
- 2011: 1
- 2012: 1
- 2013: 2
- 2015: 1

## Most-cited predicates
- K043546: Dimension RXL Max with Streamlab Analytical Workcell and Sample Transfer Module (2005), cited by 4
- K010871: TGL Flex Reagent Cartridge (2001), cited by 2
- K893973: Roche Reagent for Triglycerides (1989), cited by 2
- K781939: Reagent Kit, Triglycerides (1979), cited by 2
- K923508: Triglycerides Gpo-Pap (1993), cited by 1
- K854152: Technicon RA Systems for Triglycerides Analysis in (1985), cited by 1
- K063804: Olympus Triglyceride Test System (2007), cited by 1
- K130332: Vitros Chemistry Products Trig Slides (2013), cited by 1
- K873049: Triglycerides Gpo Without Free Glycerol (1987), cited by 1
- K870012: Triglyceride (Gpo-Trinder) Reagent (1987), cited by 1

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