Accu-Chek Guide Solo Diabetes Manager Blood Glucose Monitoring System
510(k) K213131
Active
Valid until
Not listed
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK213131 | Date10 Aug 2023 | StatusActive |
| European Union | CE/IVDD EUDAMED | Number— | Date— | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- NBW
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1345
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The Accu-Chek Guide Solo is a blood glucose monitoring system designed for self-management of diabetes. It combines a handheld meter with disposable test strips and lancets to measure capillary blood glucose levels, providing real-time results for patients to track and manage their condition effectively.
This system is intended for single-use, non-sterile applications in home healthcare settings. It operates on battery power and includes a display for reading glucose values, with regulatory authorisations under FDA 510K clearance (K213131) and IVDD compliance. The device is supplied with test strips and lancets, requiring no additional sterilisation or special handling beyond standard hygiene practices.
Other devices from Roche Diabetes Care GmbH
Questions
AI-generated answers, 18 Sep 2026
What is the primary purpose of the Accu-Chek Guide Solo diabetes manager blood glucose monitoring system, and how does it differ from other glucose meters?
The Accu-Chek Guide Solo is designed specifically for self-management of diabetes by measuring capillary blood glucose levels in real-time. Unlike some meters that require calibration or additional steps, this system combines a handheld meter with disposable test strips and lancets for straightforward use at home. It provides immediate results to help patients monitor their glucose levels effectively without needing extra equipment or sterilization beyond standard hygiene practices.
Is the Accu-Chek Guide Solo system intended for reuse, or is it meant to be used once and then discarded?
The Accu-Chek Guide Solo is explicitly designed for single-use applications. While the handheld meter itself is reusable, the test strips and lancets are disposable and meant to be used once before replacement. This design ensures accuracy and hygiene, as reuse of consumables could compromise results or introduce contamination risks.
Does the Accu-Chek Guide Solo require any special storage conditions, or can it be kept at room temperature?
The system does not specify unusual storage requirements beyond standard home healthcare conditions. Since it is non-sterile and intended for single-use, it should be stored in a clean, dry place away from direct sunlight or extreme temperatures. The test strips and lancets should remain in their original packaging until use to preserve their integrity and accuracy.
What regulatory pathways has the Accu-Chek Guide Solo followed, and what does that mean for users?
The Accu-Chek Guide Solo has undergone FDA 510(k) clearance (K213131) and complies with the In Vitro Diagnostic Device Directive (IVDD). This means the device has been evaluated for safety and performance by regulatory authorities, ensuring it meets established standards for accuracy and reliability in blood glucose monitoring. Users can trust that the system has been authorized for its intended use in home healthcare settings.