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EasyGluco Plus Blood Glucose Monitoring System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K110435

by U.s. Diagnostics Inc.

Identifiers

510(k) Number
K110435 FDA 510(k)
FDA Product Code
NBW FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.1345 FDA 510(k)
Regulation Number
862.1345 FDA 510(k)
Advisory Committee
Clinical Chemistry FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The EasyGluco Plus Blood Glucose Monitoring System is an in vitro diagnostic device classified as a blood glucose monitor. It measures glucose levels in fresh capillary whole blood through an electrochemical reaction involving dehydrogenase, providing quantitative results for diabetes management.

This system consists of a handheld monitor and disposable test strips, designed for single-patient use in home settings. It requires a small blood sample and delivers results within five seconds. The device is FDA-cleared under 510(k) K110435, with a special classification under the Clinical Chemistry advisory committee, and is intended for home use by patients with diabetes.

Frequently asked questions

Is the EasyGluco Plus system designed for reuse or is it meant for single-patient use only?

The EasyGluco Plus Blood Glucose Monitoring System is explicitly designed for single-patient use, particularly in home settings. The disposable test strips are intended to be used once per patient, ensuring accuracy and hygiene for individual monitoring.

How quickly does the EasyGluco Plus system provide blood glucose readings, and what type of blood sample does it require?

The system delivers quantitative glucose results within five seconds using a small sample of fresh capillary whole blood. This makes it convenient for patients to check their levels quickly and easily at home.

What is the primary purpose of the EasyGluco Plus Blood Glucose Monitoring System, and who is it intended for?

The device is intended for diabetes management by measuring glucose levels in blood, providing patients with real-time data to help monitor their condition. It is specifically cleared for home use by patients with diabetes.

How is the EasyGluco Plus system regulated, and what does its clearance status indicate?

The EasyGluco Plus system is FDA-cleared under the 510(k) pathway with the clearance number K110435. Its classification as 'Special' under the Clinical Chemistry advisory committee indicates it meets regulatory standards for blood glucose monitoring devices, ensuring its safety and effectiveness for its intended use.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: EasyGluco Plus® Blood Glucose Monitoring System - US Diagnostics, EASYGLUCO PLUS® - US Diagnostics, EASYGLUCO PLUS BLOOD GLUCOSE MONITORING SYSTEM (K110435) — FDA 510(k ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
U.s. Diagnostics Inc.
FDA Applicant
U. S. Diagnostics, Inc.

Sources (1)

  • FDA 510(k) K110435 24 fields · synced Sep 20, 2026