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OneTouch Select Blood Glucose Monitoring System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K072543

by Lifescan, Inc.

Identifiers

510(k) Number
K072543 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 OneTouch Select Blood Glucose Monitoring System is a portable, in vitro diagnostic device designed for self-monitoring of blood glucose levels. It falls under the category of blood glucose meters and is intended for use by individuals with diabetes to measure capillary whole blood glucose concentrations. The system provides real-time results to aid in diabetes management, supporting both home and clinical settings.

This device is supplied as a single-use, non-sterile system for home use by patients or healthcare professionals. It operates outside the body and does not require MRI safety considerations. The system includes test strips and a handheld meter with a display for reading results. Authorized for use in the United States under FDA 510(k) clearance (K072543), it is classified under product code NBW and reviewed by the Clinical Chemistry Advisory Committee.

Frequently asked questions

What is the OneTouch Select Blood Glucose Monitoring System used for?

The OneTouch Select Blood Glucose Monitoring System is designed for self-monitoring of blood glucose levels in individuals with diabetes. It measures capillary whole blood glucose concentrations to provide real-time results, helping users manage their diabetes effectively in both home and clinical settings.

Is the OneTouch Select system single-use or reusable?

The OneTouch Select Blood Glucose Monitoring System is supplied as a single-use system for test strips, while the handheld meter itself is reusable. The test strips are intended for one-time use per measurement, ensuring accuracy and hygiene.

What does the system include, and how is it supplied?

The system includes a handheld meter with a display and test strips. It is supplied as a non-sterile, single-use system for home use by patients or healthcare professionals. The meter is reusable, while the test strips are designed for one-time use per glucose measurement.

Does the OneTouch Select system require any special storage conditions?

The OneTouch Select Blood Glucose Monitoring System should be stored according to the manufacturer’s instructions to maintain its performance. Test strips should be kept in a cool, dry place, away from direct sunlight and extreme temperatures, as exposure to heat or moisture can affect their accuracy.

Is the OneTouch Select system safe for use in all environments?

The OneTouch Select system operates outside the body and does not require MRI safety considerations. However, it should be used in clean, dry environments to prevent contamination of the test strips or meter, ensuring reliable and accurate glucose readings.

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: OneTouch® | Glucose Meters, Test Strips & Diabetes Management, Home | Improving Life for People With Diabetes | LifeScan, ONETOUCH SELECT USER MANUAL Pdf Download | ManualsLib, Homepage | OneTouch®, Lifescan OneTouch Select Test Strips Blood Glucose User Manual

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Lifescan, Inc.

Sources (1)

  • FDA 510(k) K072543 24 fields · synced Oct 5, 2026