# K071706: Envoy 500 HDL; Cholesterol Reagent Kit (Model# 55301), Calibrator Kit (Model# 55118)

- Pathway: 510(k) (Traditional)
- Applicant: Clinical Data, Inc.
- Decided: Dec 20, 2007 after 182 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. The FDA summary names its predicate without a number.
- (no number) Genzyme Ultra N-geneous HDL Cholesterol Reagent: named in the summary without a submission number
- (no number) Genzyme Ultra N-geneous HDL Cholesterol Calibrator: named in the summary without a submission number

## Indications for use
The Envoy® 500 HDL Cholesterol Reagent and Envoy® 500 HDL Calibrator are intended for use with the Envoy® 500 Chemistry System as a system for the quantitative determination of high density lipoprotein (HDL) cholesterol in serum and plasma. HDL cholesterol measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases, and for the assessment of the risk of developing cardiovascular disease. This reagent is intended to be used by trained personnel in a professional setting and is not intended for home use.

Source page: https://510kreport.com/device/K071706
Methodology: https://510kreport.com/methodology