# K020488: Careside Trglyceride

- Pathway: 510(k) (Traditional)
- Applicant: Careside, Inc.
- Decided: Apr 15, 2002 after 61 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 K912844 (1991). 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)
- K912844: Kodak Ektachem Dtii System, Eastman Kodak Company (1991) Summary page 1.

## Indications for use
For in vitro diagnostic use with the CARESIDE Analyzer to measure triglycerides in anti-coagulated whole blood, plasma or serum specimens. The CARESIDE Triglyceride test aids in the diagnosis and treatment of patients with primary or secondary hyperlipidemias (hyperlipidemias may result from liver obstruction, diseases involving lipid metabolism, or various endocrine disorders. Triglyceride results are used together by the CARESIDE Analyzer with total cholesterol and HDL-cholesterol results to calculate LDL-cholesterol levels).

Source page: https://510kreport.com/device/K020488
Methodology: https://510kreport.com/methodology