# K150819: Triglycerides

- Pathway: 510(k) (Traditional)
- Applicant: Randox Laboratories Limited
- Decided: Aug 6, 2015 after 132 days
- Product code: CDT (Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides)
- Device class: 1
- Regulation: 21 CFR 862.1705
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K923508 (1993). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K923508: Triglycerides Gpo-Pap, Randox Laboratories, Ltd. (1993) Summary page 5.

## Indications for use
For the quantitative in vitro determination of Triglycerides in serum. Triglyceride measurements are used in the diagnosis and treatment of diseases involving lipid metabolism and various endocrine disorders e.g Diabetes mellitus, nephrosis and liver obstruction This in vitro diagnostic device is intended for prescription use only.

Source page: https://510kreport.com/device/K150819
Methodology: https://510kreport.com/methodology