# K232404: CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDES

- Pathway: 510(k) (Traditional)
- Applicant: Medicon Hellas S.A
- Decided: Aug 9, 2024 after 365 days
- Product code: CHH (Enzymatic Esterase--Oxidase, Cholesterol)
- Device class: 1
- Regulation: 21 CFR 862.1175
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K961274 (1996). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K925603: Olympus Cholesterol Reagent, Olympus Corp. (1993) Summary page 6.
- K981224: Direct HDL, Abbott Laboratories (1998) Summary page 6.
- K981303: Direct LDL, Abbott Laboratories (1998) Summary page 6.
- K063804: Olympus Triglyceride Test System, Olympus America, Inc. (2007) Summary page 6.

## Indications for use
CHOLESTEROL: Reagent kit intended for the quantitative determination of Cholesterol in human serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood, of lipid and lipoprotein metabolism disorders. HDL-Cholesterol: Reagent kit intended for the quantitative determination of high-density lipoprotein in human serum. Measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. LDL-Cholesterol: Reagent kit intended for the quantitative determination of low-density lipoprotein in human serum. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. TRIGLYCERIDES: Reagent kit intended for the quantitative determination of triglycerides (neutral fat) in human serum. Measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.

Source page: https://510kreport.com/device/K232404
Methodology: https://510kreport.com/methodology