Clever Choice Mini Blood Glucose Monitoring System Model TD-4265
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K093941 FDA 510(k)
- FDA Product Code
- CGA 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 Clever Choice Mini Blood Glucose Monitoring System Model TD-4265 is a glucose monitoring system that utilizes electrochemical biosensor technology with glucose oxidase to measure glucose in capillary whole blood. It comprises a glucose meter, test strips, and control solutions, and is designed for quantitative glucose readings to aid in monitoring diabetes control effectiveness.
The device is used by patients at home or clinicians in clinical settings. It is supplied as a system for self-monitoring of blood glucose and is authorized under FDA 510(k) clearance K093941, with product code CGA and regulation number 862.1345. The system supports alternative site testing only during steady-state blood glucose conditions.
Frequently asked questions
What is the Clever Choice Mini Blood Glucose Monitoring System Model TD-4265 used for?
The Clever Choice Mini Blood Glucose Monitoring System Model TD-4265 is used to measure glucose levels in capillary whole blood to aid in monitoring diabetes control effectiveness. It is designed for quantitative glucose readings and can be used by patients at home or clinicians in clinical settings for self-monitoring of blood glucose.
What components are included in the Clever Choice Mini Blood Glucose Monitoring System Model TD-4265?
The Clever Choice Mini Blood Glucose Monitoring System Model TD-4265 comprises a glucose meter, test strips, and control solutions. These components work together to enable quantitative glucose measurements using electrochemical biosensor technology with glucose oxidase.
Can the Clever Choice Mini Blood Glucose Monitoring System Model TD-4265 be used for alternative site testing?
Yes, the Clever Choice Mini Blood Glucose Monitoring System Model TD-4265 supports alternative site testing, but only during steady-state blood glucose conditions. This means alternative sites such as the forearm or palm can be used when glucose levels are stable, not during rapid changes like after meals or exercise.
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: Clever Choice Mini Blood Glucose Monitoring System Model Td-4265, Clever Choice Mini Blood Glucose Monitoring System Model Td-4265, PDF K093941 - Clever Choice Mini Blood Glucose Monitoring System Model Td-4265, fda.innolitics.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K093941 | Class II | Active |
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Manufacturer
- Manufacturer
- Taidoc Technology Corporation
Sources (1)
- FDA 510(k) K093941 24 fields · synced Oct 6, 2026