VivaChek Fad Blood Glucose Monitoring System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K222126 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 VivaChek Fad Blood Glucose Monitoring System is a portable, in-vitro diagnostic device designed for the quantitative measurement of glucose levels in whole capillary blood. It employs electrochemical technology with eight electrodes per test strip to deliver accurate results across varying haematocrit levels, humidity conditions, and operating temperatures.
This system is intended for single-use, non-invasive monitoring by patients or healthcare professionals in home, clinical, or ambulatory settings. Supplied as a sterile, disposable test strip and meter combination, it requires no special storage conditions beyond protection from extreme temperatures and moisture. The device holds FDA 510(k) clearance (K222126) and conforms to the In Vitro Diagnostic Device Directive (IVDD) under product code NBW.
Frequently asked questions
What types of settings can the VivaChek Fad Blood Glucose Monitoring System be used in, and who can operate it?
The VivaChek Fad system is designed for use in home, clinical, or ambulatory settings. It is intended for single-use monitoring by both patients and healthcare professionals, making it versatile for self-management or professional oversight of blood glucose levels.
How accurate is the VivaChek Fad system, and what conditions does it account for in its measurements?
The system uses electrochemical technology with eight electrodes per test strip to provide accurate glucose readings in whole capillary blood. It is specifically designed to perform reliably across varying haematocrit levels, humidity conditions, and operating temperatures, ensuring consistent results in diverse environments.
Is the VivaChek Fad Blood Glucose Monitoring System reusable, and what storage requirements does it have?
The VivaChek Fad system is intended for single-use only, with each test strip and meter combination supplied as a disposable unit. No special storage conditions are required beyond protecting the device from extreme temperatures and moisture, making it easy to store in standard clinical or home settings.
What regulatory approvals does the VivaChek Fad Blood Glucose Monitoring System hold, and what does that mean for its use?
The system holds FDA 510(k) clearance (K222126) and conforms to the In Vitro Diagnostic Device Directive (IVDD) under product code NBW. This means it has been evaluated for safety and performance by regulatory authorities and can be legally marketed and used in the respective jurisdictions where these approvals apply.
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: Home | VivaChek, VivaChek™ Fad Blood Glucose Monitoring System, VivaChek™ Fad Smart ..., Fad Blood Glucose Meter | VivaChek Biotech, VivaChek Blood Glucose System | Medical Device Navigator
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K222126 | Class II | Active |
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Manufacturer
- Manufacturer
- VivaChek Biotech (Hangzhou) Co., Ltd.
Sources (2)
- FDA 510(k) K222126 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced Jun 19, 2026