Accu-Chek Pocket Compass Diabetes Management Software
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K050760 FDA 510(k)
- FDA Product Code
- LZG FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5725 FDA 510(k)
- Regulation Number
- 880.5725 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Accu-Chek Pocket Compass Diabetes Management Software is a digital tool designed for managing diabetes care. It facilitates the collection, analysis, and organization of blood glucose monitoring data, supporting patients and healthcare providers in tracking trends and optimizing treatment plans.
This software is intended for use on compatible computers and integrates with supported Roche blood glucose meters. It allows users to transfer, import, and manually enter blood glucose readings, enabling detailed record-keeping and reporting. The software is classified under FDA 510(k) clearance (K050760) and is intended for general hospital use, though its primary application is in diabetes management. It is not a medical device requiring sterility or single-use and operates independently of MRI safety considerations.
Frequently asked questions
What is the Accu-Chek Pocket Compass Diabetes Management Software used for?
The Accu-Chek Pocket Compass Diabetes Management Software is designed to help patients and healthcare providers manage diabetes by collecting, analyzing, and organizing blood glucose monitoring data. It allows users to transfer readings from compatible Roche blood glucose meters, manually enter data, and generate detailed reports to track trends and refine treatment plans. This tool supports informed decision-making by visualizing patterns over time.
How is the software supplied and what devices does it integrate with?
The software is supplied as a digital download for compatible computers. It integrates exclusively with supported Roche blood glucose meters, enabling seamless transfer of glucose readings. Users can also manually input data if needed, ensuring flexibility in tracking blood glucose levels regardless of meter availability.
Is the Accu-Chek Pocket Compass Diabetes Management Software sterile or single-use?
No, the software is not a sterile product and is not intended for single-use. It operates as a standalone digital tool on computers, requiring no physical sterilization or disposal. The software’s functionality relies entirely on data processing and user interaction, making it reusable for ongoing diabetes management.
Does the software require any special storage or environmental conditions?
Unlike physical medical devices, the Accu-Chek Pocket Compass Diabetes Management Software does not require specialized storage. It is installed on a computer, so standard environmental conditions for electronic devices apply—such as protection from extreme temperatures, moisture, or physical damage. Ensure the computer meets the system requirements for optimal performance.
What regulatory pathway does this software follow?
The software is classified under the FDA’s 510(k) pathway, specifically cleared as substantially equivalent to a predicate device (K050760). It was reviewed by the FDA’s Orthopaedic and Rehabilitation Devices Advisory Committee (HO) and is intended for general hospital use, though its primary application remains diabetes management. The clearance confirms its safety and effectiveness for the stated purposes.
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: Accu-Check Pocket Compass Manual | PDF | Blood Sugar | Computer File, Accu-Chek® Apps & Software: Streamlined Diabetes Management Tools, Apps & Data Management | Roche Diabetes HCP Portal
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K050760 | Class II | Active |
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Manufacturer
- Manufacturer
- Roche Diagnostics Corp.
Sources (1)
- FDA 510(k) K050760 24 fields · synced Oct 1, 2026