# K153435: Direct HDL Cholesterol (HDL)

- Pathway: 510(k) (Traditional)
- Applicant: Randox Laboratories, Ltd.
- Decided: Jan 8, 2016 after 42 days
- Product code: LBS (Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl)
- Device class: 1
- Regulation: 21 CFR 862.1475
- 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 K982341 (1998). 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)
- K982341: Direct HDL-Cholestrol Liquid, Randox Laboratories, Ltd. (1998) Summary page 5.

## Indications for use
For the quantitative in vitro determination of HDL Cholesterol in serum and plasma. Such measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis and various other liver and renal diseases and for the assessment for the risk of developing cardiovascular disease. This in vitro diagnostic device is intended for Rx Only.

Source page: https://510kreport.com/device/K153435
Methodology: https://510kreport.com/methodology