OneTouch Verio Reflect Blood Glucose Monitoring System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K193475 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 Verio Reflect Blood Glucose Monitoring System is a portable, handheld device designed for self-monitoring of blood glucose levels. It falls under the category of in vitro diagnostic devices, specifically for clinical chemistry applications, and provides accurate blood glucose readings for individuals managing diabetes.
This system is supplied as a single-use, non-sterile device and is intended for home use. It requires no special storage conditions and is authorized under FDA 510(k) clearance (K193475) and the In Vitro Diagnostic Device Directive (IVDD). The device is compatible with the OneTouch Reveal mobile app for enhanced data management and analysis.
Frequently asked questions
What is the OneTouch Verio Reflect designed to measure, and how does it differ from other glucose monitors in its category?
The OneTouch Verio Reflect is specifically designed for self-monitoring of blood glucose levels, providing accurate readings for individuals managing diabetes. Unlike some other systems, it is a standalone handheld device that does not require calibration with plasma or serum samples—it directly measures whole blood. Its compatibility with the OneTouch Reveal mobile app also sets it apart by offering enhanced data tracking and analysis for users.
Is the OneTouch Verio Reflect intended for clinical or home use, and what does that mean for its usability?
The device is explicitly intended for home use, meaning it is designed for patients to monitor their blood glucose levels independently, without requiring a clinical setting. This makes it portable and user-friendly for daily management, though it is not sterile and must be handled in accordance with standard hygiene practices for self-testing.
How is the OneTouch Verio Reflect supplied, and what should I know about its single-use nature?
The OneTouch Verio Reflect is supplied as a single-use, non-sterile device, meaning each unit is intended for one-time use before disposal. This design reduces the risk of cross-contamination and ensures hygiene, though users should follow manufacturer guidelines for proper disposal and avoid reuse to maintain accuracy and safety.
Does the device require any special storage conditions, and how should it be handled before use?
No special storage conditions are required for the OneTouch Verio Reflect. It can be stored at room temperature and does not need refrigeration or protection from light. However, users should ensure the device is kept dry and away from extreme temperatures to maintain its functionality and accuracy.
What regulatory pathways has the OneTouch Verio Reflect followed, and how does that affect its availability?
The device has undergone FDA 510(k) clearance (K193475) under the Traditional pathway and complies with the In Vitro Diagnostic Device Directive (IVDD). This means it has been evaluated for safety and performance by regulatory authorities, confirming its suitability for self-monitoring blood glucose levels in the markets where these clearances apply. Availability may vary by region based on local regulatory approvals.
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 Verio Reflect® meter | OneTouch®, OneTouch Verio Reflect® - Product Guide, OneTouch® | Glucose Meters, Test Strips & Diabetes Management, LifeScan Europe GmbH Device Database, OneTouch Ultra Plus Reflect
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K193475 | Class II | Active |
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Manufacturer
- Manufacturer
- LifeScan Europe GmbH
Sources (2)
- FDA 510(k) K193475 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026