Autosure Voice Ii Plus, Autosure Plus Blood Glucose Test Strips, Contrex Plus I…
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K113098 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 Autosure Voice II Plus, Autosure Plus Blood Glucose Test Strips, and Contrex Plus III are diagnostic devices designed for blood glucose monitoring and voice-activated measurement feedback. The Autosure Plus Blood Glucose Test Strips fall under the category of test strips for blood glucose analysis, while the Contrex Plus III is a blood glucose meter with voice output functionality, enabling users to obtain verbal results. These devices are intended for in-home or clinical use to assist individuals in managing diabetes through accurate glucose level assessment.
The Autosure Plus Blood Glucose Test Strips and Contrex Plus III are supplied as single-use consumables, requiring no sterilization. The Contrex Plus III device is intended for use in environments where MRI safety is not a concern, as it is not labeled as MRI-compatible. Both the test strips and meter are authorized under FDA 510K clearance and the EU’s IVDD directive, ensuring compliance with regulatory standards for diagnostic devices. Storage conditions are not specified but typically involve protection from moisture and extreme temperatures.
Frequently asked questions
What types of environments are these devices intended for, and how do they assist users in diabetes management?
The Autosure Voice II Plus, Autosure Plus Blood Glucose Test Strips, and Contrex Plus III are designed for both in-home and clinical use. They help users manage diabetes by providing accurate blood glucose monitoring. The Contrex Plus III meter offers voice-activated feedback, allowing users to hear their glucose results verbally, which is particularly useful for individuals with visual impairments or those who prefer auditory confirmation. The test strips work with the meter to deliver precise readings, supporting better diabetes control through informed decision-making.
Are the test strips and meter reusable, or are they meant for single-use only? How should they be stored?
Both the Autosure Plus Blood Glucose Test Strips and the Contrex Plus III meter are supplied as single-use consumables. The test strips are designed for one-time use per test, while the meter itself is a reusable device. Storage conditions are not explicitly detailed, but like most diagnostic devices, they should be kept protected from moisture and extreme temperatures to maintain accuracy and functionality.
Can the Contrex Plus III meter be used in areas where MRI machines are present, and what regulatory approvals does it hold?
The Contrex Plus III meter is not labeled as MRI-compatible, so it should not be used in environments where MRI safety is a concern. It holds regulatory approvals under the FDA’s 510(k) clearance process and complies with the EU’s In Vitro Diagnostic Device Directive (IVDD), ensuring it meets stringent diagnostic standards for blood glucose monitoring.
How do I know if the test strips and meter are compatible with each other?
The Autosure Plus Blood Glucose Test Strips are explicitly designed to work with the Contrex Plus III meter, as part of the same product line. Since they share the same brand and manufacturer (Apex BioTechnology Corp.), they are engineered to provide accurate readings when used together. Always verify the packaging or manufacturer’s instructions to confirm compatibility, especially if sourcing replacements.
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.
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 | K113098 | Class II | Active |
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Manufacturer
- Manufacturer
- Apex Biotechnology Corp.
Sources (2)
- FDA 510(k) K113098 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026