# K970735: Boehringer Mannheim Direct HDL-Cholesterol

- Pathway: 510(k) (Traditional)
- Applicant: Randox Laboratories, Ltd.
- Decided: Jun 6, 1997 after 108 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The Randox Laboratories Limited Direct HDL - C Test Kit is an in vitro diagnostic reagent for the quantitative determination of HDL - C in serum or plasma. This method measures HDL - C directly without the need for a separate precipitation step. An inverse relationship has been found to exist between HDL - C levels and the incidence of coronary heart disease (CHD). The importance of HDL - C as a risk factor for CHD is now recognised. This test kit must be used by suitably qualified laboratory personnel under appropriate laboratory conditions.

Source page: https://510kreport.com/device/K970735
Methodology: https://510kreport.com/methodology