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In Touch Blood Glucose Monitoring System

by Eoshealth, Inc.

510(k) K133584

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK133584 Date8 Sep 2014ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1587-2016 FDA Class II initiated 18 Feb 2016 on shared 510(k) K133584

    The instructional insert for the In Touch Control Solution for use with the In Touch meter and In Touch strips as a quality control check did not contain the limitation of sensor accuracy: (1) with the use of acetaminophen (Tylenol) (2) with the use of Ascorbic Acid (vitamin C) supplementation (3) in the presence of uric acid

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
CGA
Device Class
Class II
Regulation
21 CFR Part 862.1345
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The In Touch Blood Glucose Monitoring System is a device that utilizes glucose oxidase for the quantitative measurement of glucose in fresh whole capillary blood from the fingertip. It is designed to transmit glucometer and pedometer data to a server and receive information for display.

This over-the-counter device is intended for use by persons with diabetes in home settings. It is regulated under FDA 510K clearance as a Class 2 medical device.

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the In Touch Blood Glucose Monitoring System used for?

    The In Touch Blood Glucose Monitoring System is designed for the quantitative measurement of glucose levels in fresh whole capillary blood obtained from a fingertip. It is intended for use by individuals with diabetes in home settings to help manage their condition by providing accurate blood glucose readings.

  • How does the In Touch Blood Glucose Monitoring System differ from other glucometers?

    This system utilizes glucose oxidase technology for measurement, which is a distinct chemical method compared to other glucometers. Additionally, it is capable of transmitting glucometer and pedometer data to a server, allowing for remote monitoring and data retrieval, which can be useful for tracking trends over time.

  • Is the In Touch Blood Glucose Monitoring System single-use or reusable?

    The device itself is reusable, but the test strips used for measuring glucose levels are typically single-use. Each strip is designed for one measurement to ensure accuracy and sterility. The manufacturer’s instructions should be followed for proper usage and disposal of the strips.

  • What regulatory approval does the In Touch Blood Glucose Monitoring System have?

    The In Touch Blood Glucose Monitoring System holds FDA 510K clearance, which means it has been determined to be substantially equivalent to a legally marketed device in terms of technology and safety. This clearance is specific to its intended use for home blood glucose monitoring by individuals with diabetes.

  • How should the In Touch Blood Glucose Monitoring System be stored?

    The device should be stored in a clean, dry place, away from direct sunlight and extreme temperatures. Follow the manufacturer’s guidelines for storage conditions to maintain its functionality and accuracy. Test strips, if included, should also be stored according to the provided instructions to preserve their integrity and ensure reliable results.