# K063804: Olympus Triglyceride Test System

- Pathway: 510(k) (Traditional)
- Applicant: Olympus America, Inc.
- Decided: Mar 23, 2007 after 91 days
- Product code: CDT (Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides)
- Device class: 1
- Regulation: 21 CFR 862.1705
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K961274 (1996). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961274: Olympus AU600 Clinical Chemistry Analyzer, Olympus America, Inc. (1996) Summary page 1.

## Most influential descendants
- K232404: CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDES (2024), 0 descendants of its own

## Recalls of this device
- Apr 13, 2016 · Class II · Z-1934-2016: Beckman Coulter has identified that Dipyrone (Metamizole) may cause erroneous, false low results in the following assays: Cholesterol OSR6X16, Triglyceride OSR6X118, Uric Acid OSR6X98, Lactate OSR6X93

## Indications for use
System reagent for the quantitative determination of Triglyceride concentrations in human serum and plasma on OLYMPUS analyzers Measurements of triglyceride are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders, and in the assessment of risk factors for atherosclerosis and coronary artery disease.

Source page: https://510kreport.com/device/K063804
Methodology: https://510kreport.com/methodology