Rightest Blood Glucose Monitoring System GM700, GE200
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K123008 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 GM700 and GE200 are portable, in-vitro diagnostic devices designed for the measurement of blood glucose levels. Classified under the Clinical Chemistry device type, they provide quantitative results for monitoring glucose concentrations in whole blood, aiding in the management of diabetes and related conditions.
These systems are intended for single-use, with the GM700 and GE200 models supplied as reusable meters paired with disposable test strips. The devices comply with FDA 510(k) clearance (K123008) and meet In Vitro Diagnostic Device Directive (IVDD) requirements. They are intended for use in clinical and home settings, with proper storage and handling as specified by the manufacturer to ensure accuracy and reliability.
Frequently asked questions
Are the Rightest Blood Glucose Monitoring System meters reusable, and if so, how should they be maintained for optimal performance?
Yes, the Rightest Blood Glucose Monitoring System meters (GM700 and GE200 models) are designed for reuse. Since they are reusable devices, proper maintenance as outlined by Bionime Corporation is essential to ensure accuracy and reliability. This includes regular calibration, adherence to storage guidelines, and following manufacturer instructions for cleaning and handling to prevent contamination or damage. The disposable test strips are intended for single-use only, ensuring each measurement is precise and free from cross-contamination.
What types of settings can the Rightest Blood Glucose Monitoring System be used in, and how does this affect its suitability for different users?
The Rightest Blood Glucose Monitoring System is approved for use in both clinical and home settings. This dual approval makes it suitable for healthcare professionals in hospitals or clinics as well as individuals managing diabetes at home. The system’s portability and ease of use align with the needs of both settings, ensuring consistent glucose monitoring whether in a professional environment or personal care.
How do I know if the test strips for the Rightest Blood Glucose Monitoring System are sterile, and what does this mean for their use?
The Rightest Blood Glucose Monitoring System uses disposable test strips, which are intended for single-use. While the device itself is not explicitly described as sterile, the strips are designed to be used in a manner that minimizes contamination risk, such as by maintaining a clean application site and following proper handling procedures. For clinical use, additional precautions like wearing gloves may be recommended to ensure accuracy and patient safety. Always refer to Bionime Corporation’s instructions for specific handling guidelines.
What regulatory pathways have the Rightest Blood Glucose Monitoring System GM700 and GE200 gone through, and what does this mean for users?
The Rightest Blood Glucose Monitoring System has undergone FDA 510(k) clearance (K123008) and complies with the In Vitro Diagnostic Device Directive (IVDD). This means the system has been evaluated for safety, performance, and effectiveness by regulatory authorities, ensuring it meets established standards for blood glucose measurement. Users can rely on these clearances as indicators of the system’s reliability and compliance with international and U.S. regulatory requirements for diagnostic devices.
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 | K123008 | Class II | Active |
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Manufacturer
- Manufacturer
- Bionime Corporation
Sources (2)
- FDA 510(k) K123008 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026