GlucoSure Link Blood Glucose Monitoring System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K212140 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 GlucoSure Link Blood Glucose Monitoring System is a blood glucose test system classified under System, Test, Blood Glucose (Product Code: NBW). It is designed for the quantitative measurement of glucose levels in fresh capillary whole blood samples obtained from alternative sites such as fingertips, forearms, or palms, ensuring reliable results during steady-state conditions.
This device is supplied as a reusable monitoring system with single-use test strips and features Bluetooth connectivity for data transmission. Authorized under FDA 510(k) clearance (K212140) and In Vitro Diagnostic Device Directive (IVDD), it operates in home healthcare settings. Storage and handling instructions must be followed as per manufacturer guidelines to maintain accuracy and sterility.
Frequently asked questions
What types of blood samples can the GlucoSure Link system test, and where can the samples be taken from?
The GlucoSure Link Blood Glucose Monitoring System is designed to measure glucose levels in fresh capillary whole blood samples. These samples can be obtained from alternative sites such as fingertips, forearms, or palms, making it convenient for users who may find traditional fingertip testing less comfortable or impractical.
Is the GlucoSure Link system reusable, and how are the test strips supplied?
Yes, the GlucoSure Link system itself is reusable, which helps reduce waste over time. However, the test strips are single-use components that must be replaced for each measurement. This design ensures accuracy and sterility for each test.
How does the GlucoSure Link system connect to other devices or software, and what is its intended use environment?
The GlucoSure Link system features Bluetooth connectivity, allowing it to transmit glucose measurement data to compatible devices or software. It is specifically authorized for use in home healthcare settings, making it ideal for patients managing diabetes outside of clinical environments.
What storage and handling guidelines should be followed to maintain the accuracy and performance of the GlucoSure Link system?
While the exact storage instructions are provided by the manufacturer, following their guidelines is critical to maintaining the system’s accuracy and sterility. Proper storage ensures the test strips and reusable components remain effective for reliable glucose monitoring, particularly in steady-state conditions.
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: GlucoSure Link Blood Glucose Monitoring System, K212140 FDA 510(k) - GlucoSure Link Blood Glucose Monitoring..., GlucoSure Link Blood Glucose Monitoring System, PDF Blood Glucose Monitoring System - apexbio.com
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 | K212140 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Apex Biotechnology Corp.
Sources (2)
- FDA 510(k) K212140 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026