# K982529: Randox Direct LDL Cholesterol

- Pathway: 510(k) (Traditional)
- Applicant: Randox Laboratories, Ltd.
- Decided: Sep 11, 1998 after 53 days
- Product code: MRR (System, Test, Low Density, Lipoprotein)
- Device class: 1
- Regulation: 21 CFR 862.1475
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K161691: Direct LDL Cholesterol (LDL) (2017), 0 descendants of its own

## Recalls of this device
- Jan 27, 2023 · Class II · Z-1268-2023: Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig), and Triglycerides_2 (Trig_2) Impacting Magnesium (Mg) Results

## Indications for use
The Randox Laboratories Limited Direct LDL Cholesterol Test Kit is an in vifro diagnostic reagent for use in the quantitative determination of LDL Cholesterol in serum and plasma. The method, an elimination enzymatic assay, does not require any sample preparation. Accurate measurement of LDL Cholesterol is of vital importance in therapies that focus on lipid reduction to prevent atherosclerosis or reduce its progress. Suitably qualified laboratory personnel under appropriate laboratory conditions must use this Test Kit.

Source page: https://510kreport.com/device/K982529
Methodology: https://510kreport.com/methodology