# K150654: Cholesterol

- Pathway: 510(k) (Traditional)
- Applicant: Randox Laboratories, Ltd.
- Decided: Sep 29, 2015 after 200 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: 1 generation back to K923504 (1994). 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)
- K923504: Cholesterol Enzymatic Endpoint, Randox Laboratories, Ltd. (1994) Summary page 5.

## Indications for use
For the quantitative in vitro determination of Cholesterol in serum and plasma. Cholesterol measurements are used in the diagnosis and treatments of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.

Source page: https://510kreport.com/device/K150654
Methodology: https://510kreport.com/methodology