# K014032: Olympus LDL Cholesterol Reagent, Olympus LDL Cholesterol Calibrator, Olympus HDL/LDL Cholesterol Control Sera

- Pathway: 510(k) (Traditional)
- Applicant: Olympus America, Inc.
- Decided: Feb 8, 2002 after 64 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 LDL Cholesterol Test System contains LDL Cholesterol Reagent, LDL 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 LDL Cholesterol concentrations in human serum and plasma. The Olympus LDL Cholesterol Calibrator is a lyophilized human serum intended to provide an LDL concentration of known value for use in calibration of the Olympus LDL 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 a designed to monitor the recovery and precision of the Olympus LDL Cholesterol Reagent used on the Olympus family of Clinical Chemistry Analyzers. LDL Cholesterol levels play a causal role in the development of coronary artery disease and is used for the measurement of the LDL Cholesterol concentration in serum and plasma.

Source page: https://510kreport.com/device/K014032
Methodology: https://510kreport.com/methodology