Smartest Glucowise Blood Glucose Monitoring System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K122525 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 Smartest Glucowise Blood Glucose Monitoring System is a Blood Glucose Monitoring Device (NBW) designed for the quantitative measurement of glucose levels in fresh capillary whole blood samples. It is classified under the Clinical Chemistry device type and intended for use with blood drawn from fingertips or the forearm. The system provides results to aid in diabetes management, supporting both healthcare professionals and individuals with diabetes mellitus in monitoring treatment effectiveness.
This device is supplied as a single-use system and requires no sterilisation before use. It is intended for in-clinic and home use, with no specific MRI safety restrictions noted. The system is authorised under FDA 510(k) clearance (K122525) as substantially equivalent to a predicate device, with a special review designation. No third-party verification is required for its use.
Frequently asked questions
What is the Smartest Glucowise Blood Glucose Monitoring System used for?
The Smartest Glucowise Blood Glucose Monitoring System is designed for the quantitative measurement of glucose levels in fresh capillary whole blood samples. It is intended to assist healthcare professionals and individuals with diabetes mellitus in monitoring blood glucose levels to support diabetes management and evaluate treatment effectiveness. The device provides results that help track glucose trends over time, aiding in clinical decision-making.
How is the Smartest Glucowise Blood Glucose Monitoring System supplied, and does it require sterilization?
The Smartest Glucowise Blood Glucose Monitoring System is supplied as a single-use system, meaning each unit is intended for one-time use only. No sterilization is required before use, as the device is designed for immediate, single-patient application. This ensures safety and reduces cross-contamination risks.
Where can the Smartest Glucowise Blood Glucose Monitoring System be used, and what are its safety considerations?
This system is approved for both in-clinic and home use. It is intended for blood samples drawn from fingertips or the forearm. There are no specific MRI safety restrictions noted for this device, meaning it can be safely used in environments where MRI procedures are performed without interference. Always follow local guidelines for proper handling and disposal.
Does the Smartest Glucowise Blood Glucose Monitoring System require third-party verification for use?
No third-party verification is required for the use of the Smartest Glucowise Blood Glucose Monitoring System. The device holds FDA 510(k) clearance (K122525) as substantially equivalent to a predicate device, which means it meets regulatory standards without needing additional external validation for clinical application.
What types of blood samples can be tested with the Smartest Glucowise Blood Glucose Monitoring System?
The Smartest Glucowise Blood Glucose Monitoring System is specifically designed to measure glucose levels in fresh capillary whole blood samples. It is intended for use with blood drawn from either fingertips or the forearm, providing flexibility for both clinical and home testing environments.
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: Smartest Glucowise Blood Glucose Monitoring System, and Smartest ..., Smartest Glucowise Blood Glucose Monitoring System, and Smartest ..., Smartest Glucowise Blood Glucose Monitoring System, And Smartest ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K122525 | Class II | Active |
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Manufacturer
- Manufacturer
- Biotest Medical Corp.
Sources (1)
- FDA 510(k) K122525 24 fields · synced Oct 5, 2026