Rightest Blood Glucose Monitoring System, Model GM110
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K081450 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 Rightest Blood Glucose Monitoring System, Model GM110, is a blood glucose meter classified as a glucose monitoring device under the Clinical Chemistry nomenclature. It is designed to measure and display blood glucose levels from capillary whole blood samples, providing quantitative results for diabetes management.
This system is intended for single-use in clinical and home healthcare settings, supplied sterile and packaged individually. It operates with disposable test strips and a reusable meter, adhering to FDA 510(k) clearance (K081450) and IVDD compliance. Storage requires protection from extreme temperatures and moisture, as specified in the manufacturer’s instructions.
Frequently asked questions
Is the Rightest Blood Glucose Monitoring System, Model GM110, designed for reuse or single-use, and how is it supplied?
The Rightest Blood Glucose Monitoring System, Model GM110 is designed for single-use in clinical and home healthcare settings. The meter itself is reusable, but the test strips and associated components are disposable. The system is supplied sterile and packaged individually for each use, ensuring cleanliness and safety per the manufacturer’s specifications.
What storage conditions should I follow for the Rightest Blood Glucose Monitoring System, Model GM110?
The Rightest Blood Glucose Monitoring System, Model GM110 requires storage in a controlled environment to prevent damage. It must be protected from extreme temperatures and moisture, as outlined in the manufacturer’s instructions. Proper storage ensures the meter’s accuracy and longevity.
What type of blood sample does the Rightest Blood Glucose Monitoring System, Model GM110 use, and where is it typically used?
The Rightest Blood Glucose Monitoring System, Model GM110 measures blood glucose levels from capillary whole blood samples, which are typically obtained from a fingerstick. It is intended for use in both clinical settings (like hospitals or labs) and home healthcare environments for diabetes management.
How does the regulatory pathway for the Rightest Blood Glucose Monitoring System, Model GM110 differ from other glucose meters?
The Rightest Blood Glucose Monitoring System, Model GM110 follows a special 510(k) clearance pathway under the FDA (K081450) and complies with the In Vitro Diagnostic Device Directive (IVDD). This classification under Clinical Chemistry (product code NBW) reflects its role as a quantitative glucose monitoring device, distinguishing it from other meters based on its regulatory submission history and intended use.
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 | K081450 | Class II | Active |
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Manufacturer
- Manufacturer
- Bionime Corporation
Sources (2)
- FDA 510(k) K081450 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026