# K014015: Olympus HDL Cholesterol Reagent; Olympus HDL Cholesterol Calibrator; Olympus HDL/LDL Cholesterol Control Sera

- Pathway: 510(k) (Traditional)
- Applicant: Olympus America, Inc.
- Decided: Feb 8, 2002 after 65 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 Olympus HDL Cholesterol Test System contains HDL Cholesterol Reagent, HDL Cholesterol Calibrator, and Assayed HDL/LDL Cholesterol Control materials intended for use on the Olympus Family of Clinical Chemistry Analyzers for the quantitative determination of HDL Cholesterol concentrations in human serum and plasma. The Olympus HDL Cholesterol Calibrator is a lyophilized human serum intended to provide an HDL concentration of known value for use in calibration of the Olympus HDL Cholesterol Reagent used on the Olympus family of Clinical Chemistry Analyzers. The Olympus HDL/LDL Cholesterol Control consists of lyophilized human sera. These assayed control sera are designed to monitor the recovery and precision of the Olympus HDL Cholesterol Reagent used on the Olympus family of Clinical Chemistry Analyzers. HDL Cholesterol demonstrates a strong and independent association with the risk of coronary artery disease and is used in the initial screening for hypercholesterolemia.

Source page: https://510kreport.com/device/K014015
Methodology: https://510kreport.com/methodology