Rightest Blood Glucose Monitoring System, Model GM100
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K081451 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 GM100, is a blood glucose meter classified as a glucose monitoring device under the FDA’s Clinical Chemistry category. 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, non-invasive monitoring in home healthcare settings. Supplied as a sterile, disposable test strip and meter combination, it requires no special storage conditions beyond room temperature. The device holds FDA 510(k) clearance and In Vitro Diagnostic Device Directive (IVDD) compliance, ensuring regulatory adherence for clinical use.
Frequently asked questions
Is the Rightest Blood Glucose Monitoring System, Model GM100, designed for repeated use or single-use only?
The Rightest Blood Glucose Monitoring System, Model GM100 is explicitly designed for single-use. It is supplied as a sterile, disposable test strip and meter combination, ensuring each use is with a new, dedicated strip for accurate and hygienic blood glucose measurement.
What kind of storage conditions are required for the Rightest Blood Glucose Monitoring System, Model GM100?
The system requires no special storage conditions beyond standard room temperature. This makes it convenient for home healthcare use, as it doesn’t need refrigeration or controlled environments.
How is the Rightest Blood Glucose Monitoring System, Model GM100 regulated, and what does that mean for clinical use?
The device holds FDA 510(k) clearance under the Clinical Chemistry category, meaning it has been deemed substantially equivalent to a legally marketed predicate device. It also complies with the In Vitro Diagnostic Device Directive (IVDD), ensuring it meets regulatory standards for clinical accuracy and safety in blood glucose monitoring.
What type of blood sample does the Rightest Blood Glucose Monitoring System, Model GM100 use, and where is it typically used?
The system measures blood glucose levels from capillary whole blood samples, which are typically obtained from a small fingerstick. It is intended for home healthcare settings, providing quantitative results to help manage diabetes.
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: BIONIME Rightest GM100 - Blood Glucose Meter Manual, BIONIME Rightest GM100 Instructions For Use - ManualsLib, PDF Blood Glucose Monitoring System Instructions for Use - Bionime, BIONIME Rightest GM100 User Manual - Download PDF | Manualzz
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 | K081451 | Class II | Active |
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Manufacturer
- Manufacturer
- Bionime Corporation
Sources (2)
- FDA 510(k) K081451 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026