Achtung TD-4207, Clever Chek TD-4209, Clever Chek TD-4222
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K042005 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 Achtung TD-4207, Clever Chek TD-4209, and Clever Chek TD-4222 are quantitative glucose monitoring systems designed for measuring glucose levels in capillary whole blood obtained from fingersticks. These devices employ electrochemical biosensor technology to determine glucose concentration, serving both clinical and home-use settings for healthcare professionals and patients. Classified under the product code NBW, they fall within the Clinical Chemistry category and are intended for point-of-care glucose assessment. The systems are intended for single-use applications, ensuring accuracy and reliability in glucose measurement.
These glucose test systems are supplied as single-use devices, requiring no sterilization or reprocessing. They are not intended for MRI environments and are not reusable. Each system is designed for use with capillary whole blood samples from fingersticks, adhering to regulatory standards as evidenced by FDA 510(k) clearance under Special review (K042005). The devices are manufactured by Taidoc Technology Corporation and are distributed with clear instructions for single-use application in clinical or home settings.
Frequently asked questions
What is the Clever Chek TD-4222 used for?
The Clever Chek TD-4222 is a quantitative glucose monitoring system designed to measure glucose levels in capillary whole blood obtained from fingersticks. It uses electrochemical biosensor technology to provide reliable glucose concentration readings, making it suitable for both clinical and home-use settings where point-of-care glucose assessment is required.
How is the Clever Chek TD-4222 supplied and intended for use?
The Clever Chek TD-4222 is supplied as a single-use device, meaning each test strip or system is intended for one-time use only. It does not require sterilization or reprocessing, and it is explicitly designed for capillary whole blood samples from fingersticks. The system includes clear instructions for single-use application in either clinical or home environments.
Are these devices reusable or suitable for MRI environments?
No, the Clever Chek TD-4222 and related models (TD-4207, TD-4209) are not reusable. They are designed for single-use only to ensure accuracy and reliability. Additionally, these devices are not intended for use in MRI environments, as they were not tested or approved for such settings.
What regulatory approvals do these glucose monitors hold?
The Achtung TD-4207, Clever Chek TD-4209, and Clever Chek TD-4222 have received FDA 510(k) clearance under Special Review (K042005). This classification under product code NBW (Clinical Chemistry) confirms their substantial equivalence to predicate devices, ensuring compliance with U.S. regulatory standards for point-of-care glucose testing.
How should the Clever Chek TD-4222 be stored?
While the provided data does not specify storage conditions explicitly, single-use glucose monitoring systems like the Clever Chek TD-4222 typically require protection from extreme temperatures, moisture, and direct sunlight. Follow the manufacturer’s instructions included in the packaging for optimal storage to maintain device integrity and accuracy. Taidoc Technology Corporation’s guidelines should be consulted for precise storage recommendations.
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: Achtung Td-4207, Clever Chek Td-4209, Clever Chek Td-4222, Achtung Td-4207, Clever Chek Td-4209, Clever Chek Td-4222, PDF AUG 27 2OM - 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 | K042005 | Class II | Active |
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Manufacturer
- Manufacturer
- Taidoc Technology Corporation
Sources (1)
- FDA 510(k) K042005 24 fields · synced Oct 5, 2026