Advocate Redi-Code Dash Blood Glucose Monitoring System Model TD-4276
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K093940 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 Advocate Redi-Code Dash Blood Glucose Monitoring System Model TD-4276 is a System, Test, Blood Glucose, Over The Counter device, classified under Clinical Chemistry. It is designed for the quantitative measurement of glucose levels in fresh capillary whole blood, enabling users to monitor diabetes management at home.
This system is intended for single-use applications and is regulated under FDA 510(k) clearance (K093940) with a Special classification under product code NBW. It operates in non-sterile settings and requires no special MRI safety considerations. The device is supplied as a complete monitoring system, with no additional storage or handling requirements specified beyond standard home-use conditions.
Frequently asked questions
What is the primary use of the Advocate Redi-Code Dash Blood Glucose Monitoring System Model TD-4276, and who would typically use it?
The Advocate Redi-Code Dash Blood Glucose Monitoring System Model TD-4276 is designed for the quantitative measurement of glucose levels in fresh capillary whole blood. It is intended for home use, making it ideal for individuals managing diabetes who need to regularly monitor their blood glucose levels as part of their daily diabetes care routine.
Is the Advocate Redi-Code Dash Blood Glucose Monitoring System Model TD-4276 meant for single-use or repeated use?
The device is explicitly designed for single-use applications. This means each test strip or component intended for blood glucose measurement is intended to be used once and then discarded, ensuring accuracy and hygiene for each use.
How is the Advocate Redi-Code Dash Blood Glucose Monitoring System Model TD-4276 supplied, and are there any special storage requirements?
The system is supplied as a complete monitoring system, ready for immediate use at home. No additional storage requirements are specified beyond standard home-use conditions, meaning it can be stored in typical household environments without special precautions.
What regulatory pathway was followed for the FDA clearance of this device, and what does that classification mean for users?
The Advocate Redi-Code Dash Blood Glucose Monitoring System Model TD-4276 was cleared through the FDA’s 510(k) process, specifically under the product code NBW with a Special classification. This classification indicates that the device is substantially equivalent to a legally marketed device and is intended for over-the-counter use, meaning it is available without a prescription for consumers managing diabetes.
Does this device require any special handling or safety considerations, such as MRI compatibility?
The device does not require any special MRI safety considerations, as it is not designed for use in an MRI environment. It is intended for non-sterile settings, such as home use, and does not involve procedures that would necessitate sterile conditions.
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: Advocate Redi-code Dash Blood Glucose Monitoring System Model Td-4276, Advocate Redi-code Dash Blood Glucose Monitoring System Model Td-4276 ..., PDF APR 2 3 2010 - Food and Drug Administration
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K093940 | Class II | Active |
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Manufacturer
- Manufacturer
- Taidoc Technology Corporation
Sources (1)
- FDA 510(k) K093940 24 fields · synced Sep 19, 2026