# K971113: Dma Triglycerides Procedures

- Pathway: 510(k) (Traditional)
- Applicant: Data Medical Associates, Inc.
- Decided: May 29, 1997 after 63 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
For the quantitative determination of Triglycerides in serum and plasma. Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or vatious endocrine disorders. Elevated serum triglyceride levels are seen in primary disorders of lipid f metabolism or hyperlipoproteinemia secondary to known diseases. Furthermore, in conjunction with high-density lipoprotein and total serum cholesterol, a triglyceride determination provides valuable information for the assessment of coronary heart disease risk. The clinical significance and management of hyperlipoproteinemia depends on the triglyceride distribution among the major serum lipoproteins.

Source page: https://510kreport.com/device/K971113
Methodology: https://510kreport.com/methodology