Rightest Blood Glucose Monitoring System, Model GM550
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K092052 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 GM550, is a portable in vitro diagnostic device designed for self-monitoring of blood glucose levels. Classified under the product code NBW, it is intended for use by both home users and healthcare professionals to measure capillary whole blood glucose concentrations. The system provides rapid and accurate results, supporting diabetes management through continuous monitoring outside the body. Its design adheres to clinical chemistry standards for reliable diagnostic performance.
The GM550 is supplied as a single-use or reusable system, depending on the test strips and lancets used, and is intended for use in non-clinical settings such as homes or outpatient care. It is not sterile and requires proper handling to ensure accuracy; test strips and lancets must be stored according to manufacturer instructions to maintain performance. The device has been cleared by the FDA under 510(k) number K092052, with a decision date of June 18, 2010, and is classified under the Clinical Chemistry advisory committee. No MRI safety information is provided in the specifications.
Frequently asked questions
What is the Rightest GM550 Blood Glucose Monitor used for?
The Rightest GM550 is designed for self-monitoring of blood glucose levels in non-clinical settings, such as homes or outpatient care. It measures capillary whole blood glucose concentrations to support diabetes management by providing reliable results outside traditional clinical environments. This makes it suitable for both home users and healthcare professionals who need portable, on-demand glucose monitoring.
Is the Rightest GM550 Blood Glucose Monitor sterile?
No, the Rightest GM550 Blood Glucose Monitor is not sterile. It is intended for use in non-clinical settings where sterility is not required for the specific application of blood glucose measurement. However, proper handling and adherence to manufacturer instructions for test strips and lancets are essential to ensure accurate results and maintain device performance.
Can the Rightest GM550 Blood Glucose Monitor be reused?
The Rightest GM550 system itself is reusable, but its performance depends on the type of test strips and lancets used. Some components, like test strips, may be single-use, while others may allow for reuse. Always follow the manufacturer’s guidelines for the specific strips and lancets to ensure accuracy and reliability. Reuse of consumables should align with their intended design to avoid compromising test results.
How should test strips and lancets for the GM550 be stored?
Test strips and lancets for the Rightest GM550 must be stored according to the manufacturer’s instructions to maintain their performance and accuracy. Improper storage, such as exposure to moisture, heat, or light, can degrade the strips and affect glucose readings. Always check the packaging for specific storage conditions, typically involving cool, dry environments and sealed containers until use.
What regulatory clearance does the Rightest GM550 Blood Glucose Monitor hold?
The Rightest GM550 Blood Glucose Monitor has been cleared by the FDA under the 510(k) process, with clearance number K092052. It was determined to be substantially equivalent to a predicate device and falls under the Clinical Chemistry advisory committee. This clearance allows it to be marketed for its intended use in the United States, adhering to clinical chemistry standards for diagnostic performance.
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 GM550 USER MANUAL Pdf Download | ManualsLib, BIONIME RIGHTTEST GM550 USER MANUAL Pdf Download, PDF Blood Glucose Monitoring System - RIGHTEST 瑞特, GM550 Blood Glucose Meter - BIONIMEUSA.COM, PDF Blood Glucose Monitoring System GM550 - Bionime
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K092052 | Class II | Active |
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Manufacturer
- Manufacturer
- Bionime Corporation
Sources (1)
- FDA 510(k) K092052 24 fields · synced Oct 6, 2026