One Touch Ultra And One Touch Induo Blood Glucose Monitoring Systems
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K024194 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 and OneTouch Induo Blood Glucose Monitoring Systems are portable, self-monitoring devices designed for measuring blood glucose levels in individuals with diabetes. These systems fall under the category of blood glucose meters, intended for home use to provide real-time glucose readings from a small blood sample. They are classified as in vitro diagnostic devices, enabling patients to track glycemic control and make informed dietary or treatment adjustments. The systems include meters, test strips, and lancets, forming a complete solution for glucose monitoring.
These systems are supplied as single-use, non-sterile devices for home healthcare settings. The OneTouch Ultra and Induo meters are not MRI-compatible and must be handled according to manufacturer guidelines to ensure accuracy and reliability. Each system is authorized under FDA 510(k) clearance (K024194) and is intended for use with compatible test strips and lancets. Storage conditions require protection from extreme temperatures and moisture, as specified in the accompanying instructions. No additional regulatory approvals beyond the stated 510(k) clearance are implied.
Frequently asked questions
What are the OneTouch Ultra and Induo systems used for?
These systems are designed for individuals with diabetes to monitor blood glucose levels at home. By providing real-time readings from a small blood sample, they help patients track glycemic control and make informed decisions about diet, medication, or lifestyle adjustments. The meters are part of a complete solution, including test strips and lancets, to simplify daily glucose monitoring.
Are the OneTouch Ultra and Induo meters single-use or reusable?
The meters themselves are reusable devices, but the test strips and lancets are intended for single-use only. This design ensures accuracy and hygiene for each measurement, as reusing consumables could compromise reliability or introduce contamination risks.
How should these meters be stored?
Storage requires protection from extreme temperatures and moisture. The meters and their components should be kept in a dry environment, away from direct sunlight or humidity, to maintain their functionality and accuracy. Always follow the manufacturer’s instructions for optimal storage conditions.
Can these meters be used in an MRI environment?
No, the OneTouch Ultra and Induo meters are not MRI-compatible. If a patient requires an MRI scan, the meter should be removed from the monitoring area and stored safely, as exposure to MRI fields could potentially affect electronic devices.
What regulatory clearance do these systems hold?
Both the OneTouch Ultra and Induo Blood Glucose Monitoring Systems are authorized under FDA 510(k) clearance (K024194). This clearance confirms they meet regulatory standards for safety and effectiveness as in vitro diagnostic devices for home blood glucose monitoring. No additional regulatory approvals beyond this clearance are implied.
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, Products | OneTouch®, Home | Improving Life for People With Diabetes | LifeScan, Blood Glucose Monitoring | OneTouch® Professional Support, OneTouch® Ultra®2 meter | OneTouch® Professional Support
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K024194 | Class II | Active |
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Manufacturer
- Manufacturer
- Lifescan, Inc.
Sources (1)
- FDA 510(k) K024194 24 fields · synced Oct 5, 2026