# K042443: Spotchem HDL, Total Cholesterol and Triglyceride Reagent Tests and Panel

- Pathway: 510(k) (Traditional)
- Applicant: Arkray, Inc.
- Decided: Nov 24, 2004 after 76 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
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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The SpotChem EZ Total Cholesterol, HDL and Triglyceride test and panel system are an in vitro diagnostic procedures intended to measure Total Cholesterol/HDLfTriglyceride quantitatively in human serum and plasma on the SpotChem EZ analyzer. Total Cholesterol measurements are used the diagnosis and treatment of lipid and lipoprotein metabolism disorders. HDL-Cholesterol measurements are used the diagnosis and treatment of lipid and lipoprotein metabolism disorders. Triglyceride measurements are used in the 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/K042443
Methodology: https://510kreport.com/methodology