Ascensia Elite Diabetes Care System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K043311 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 Ascensia Elite Diabetes Care System is a blood glucose monitoring device designed for self-management of diabetes. It includes a meter, test strips, and code strips to measure and display blood glucose levels, enabling users to track and manage their glycemic control. The system is classified under clinical chemistry devices and is intended for in-home use by patients or caregivers. It provides quantitative results to aid in diabetes management decisions.
This system is supplied as a reusable meter paired with single-use test and code strips. The meter requires no sterilization as it is not intended for invasive procedures. It is not MRI-compatible and must be used outside magnetic resonance environments. The device is authorized for use in the United States under FDA 510(k) clearance (K043311) and is intended for professional and consumer use in diabetes care settings. Storage conditions are not specified but should follow standard guidelines for glucose monitoring systems.
Frequently asked questions
What is the Ascensia Elite Diabetes Care System used for?
The Ascensia Elite Diabetes Care System is designed for self-management of diabetes by measuring and displaying blood glucose levels. It helps users and caregivers track glycemic control, enabling informed decisions about diabetes management in home settings. The system provides quantitative results to support daily monitoring and treatment adjustments.
How is the Ascensia Elite Diabetes Care System supplied?
The system consists of a reusable meter paired with single-use test strips and code strips. The meter itself is not intended for invasive procedures, so it does not require sterilization. The single-use strips ensure hygiene and accuracy for each measurement, while the reusable meter reduces waste and cost over time.
Is the Ascensia Elite Diabetes Care System safe for use in an MRI environment?
No, the Ascensia Elite Diabetes Care System is not MRI-compatible. It must be used outside magnetic resonance environments to avoid potential interference or damage to the device. Always follow manufacturer guidelines to ensure safe and accurate glucose monitoring.
Can the Ascensia Elite Diabetes Care System be reused or is it single-use?
The meter itself is reusable, while the test strips and code strips are designed for single-use only. This setup allows for consistent performance and hygiene, as each test strip is intended for one measurement. The reusable meter helps minimize waste and ongoing expenses for users.
What storage conditions should I follow for the Ascensia Elite Diabetes Care System?
While specific storage conditions are not detailed in the product information, it is recommended to follow standard guidelines for glucose monitoring systems. Store the meter and strips in a cool, dry place, away from direct sunlight and extreme temperatures. Proper storage ensures accuracy and longevity of the device and test strips.
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: PDF Bayer Ascensia Elite (#21296) - User Manual Search Engine, Bayer HealthCare Blood Glucose Meter MODEL Ascensia Elite : - Bayer ..., Bayer healthcare Ascensia Elite Manuals | ManualsLib, Bayer HealthCare Blood Glucose Meter MODEL Ascensia Elite : - Bayer ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K043311 | Class II | Active |
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Manufacturer
- Manufacturer
- Bayer HealthCare, LLC
Sources (1)
- FDA 510(k) K043311 24 fields · synced Oct 1, 2026