# K982341: Direct HDL-Cholestrol Liquid

- Pathway: 510(k) (Traditional)
- Applicant: Randox Laboratories, Ltd.
- Decided: Jul 30, 1998 after 38 days
- Product code: LBS (Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl)
- 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.
3 later devices descend from it; 3 cite it directly.
0 of 4 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
- K153435: Direct HDL Cholesterol (HDL) (2016), 0 descendants of its own
- K132031: Afinion Lipid Panel and Afinion Lipid Panel Control (2014), 0 descendants of its own
- K031924: Vitros 5,1 FS Chemistry System, Vitros Chemistry Products DHDL Reagent Pack, Calibrator Kit 19, FS Calibrator 1 (2003), 0 descendants of its own

## Recalls of this device
- Mar 17, 2016 · Class II · Z-1653-2016: Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirmed that falsely depre

## Indications for use
The Randox Liquid Direct HDL-Cholesterol (HDL-C) test kit is an in vitro diagnostic reagent for the quantitative determination of HDL-Cholesterol in human serum and plasma. Accurate measurement of HDL-C is of importance when assessing patient risk from coronary heart disease. In this diagnostic test kit a method for direct measurement of HDL-C, without sample pretreatment is presented. It is recommended that this test kit be used by suitable qualified laboratory personnel under appropriate laboratory conditions.

Source page: https://510kreport.com/device/K982341
Methodology: https://510kreport.com/methodology