# K161691: Direct LDL Cholesterol (LDL)

- Pathway: 510(k) (Traditional)
- Applicant: Randox Laboratories Limited
- Decided: Mar 20, 2017 after 273 days
- Product code: MRR (System, Test, Low Density, Lipoprotein)
- 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 K982529 (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)
- K982529: Randox Direct LDL Cholesterol, Randox Laboratories, Ltd. (1998) Summary page 5.

## Indications for use
For the quantitative in vitro determination of LDL-cholesterol concentration in human plasma and serum. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis and various liver and renal diseases. This in vitro diagnostic device is intended for prescription use only.

Source page: https://510kreport.com/device/K161691
Methodology: https://510kreport.com/methodology