OneTouch Ultra Plus Flex Blood Glucose Monitoring System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K151611 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 Ultra Plus Flex Blood Glucose Monitoring System is a portable, handheld device classified as a blood glucose meter. It measures capillary blood glucose levels from small blood samples, providing results in as little as five seconds. Designed for individuals managing diabetes, it offers real-time monitoring to support glycemic control. The system includes a meter, test strips, and a lancing device for sample collection.
This system is supplied as a single-use, non-sterile device intended for home use. It operates via disposable test strips and requires no external power source beyond the included batteries. The device is Bluetooth-enabled for connectivity with companion mobile applications, facilitating data tracking and analysis. Authorized under FDA 510(k) clearance (K151611), it adheres to clinical chemistry standards and is intended for use in non-MRI environments. Storage should follow manufacturer guidelines to maintain accuracy and functionality.
Frequently asked questions
What is the OneTouch Ultra Plus Flex Blood Glucose Monitoring System used for?
This system is designed for individuals managing diabetes to monitor their capillary blood glucose levels in real time. By providing quick, accurate readings from small blood samples, it helps users track glycemic control and make informed decisions about their health. The device is intended for home use and supports daily glucose monitoring.
How is the OneTouch Ultra Plus Flex system supplied, and is it sterile?
The system is supplied as a single-use, non-sterile device, including a meter, test strips, and a lancing device. Since it is intended for home use, sterility is not required, but proper hygiene practices should be followed when handling the device and collecting blood samples to minimize infection risk.
Does the OneTouch Ultra Plus Flex Blood Glucose Monitoring System require batteries or external power?
No, the device operates using disposable test strips and requires no external power source beyond the included batteries. The batteries provide the necessary power for the meter to function, and they should be replaced as needed to ensure reliable performance.
Can I connect the OneTouch Ultra Plus Flex to a mobile app, and what are the benefits?
Yes, the OneTouch Ultra Plus Flex is Bluetooth-enabled, allowing it to connect with companion mobile applications. This connectivity facilitates data tracking and analysis, enabling users to monitor trends over time, share results with healthcare providers, and receive insights to support better diabetes management.
How should I store the OneTouch Ultra Plus Flex Blood Glucose Monitoring System to maintain accuracy?
To maintain accuracy and functionality, store the device according to the manufacturer’s guidelines. This typically includes keeping it in a cool, dry place, away from direct sunlight or extreme temperatures, and ensuring test strips are stored properly to prevent moisture or contamination. Proper storage helps preserve the device’s performance and reliability.
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® | Blutzuckermessgeräte, Zubehör & Diabetes-Tipps, Blutzuckermessgeräte, Teststreifen, Insulinpumpen | OneTouch®, Bluetooth blood glucose meter - OneTouch Ultra Plus Flex™ - Lifescan, OneTouch Ultra Plus Flex™ - Product Guide
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K151611 | Class II | Active |
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Manufacturer
- Manufacturer
- Lifescan Europe
Sources (1)
- FDA 510(k) K151611 24 fields · synced Oct 5, 2026