Contour Next USB Blood Glucose Monitoring System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K121087 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 Contour Next USB Blood Glucose Monitoring System is a Blood Glucose Meter (Device Type: NBW) designed for self-monitoring of blood glucose levels. It provides accurate, real-time readings to assist individuals with diabetes in managing their condition. The system features a USB interface for data transfer, enabling connectivity with compatible software for trend analysis and reporting. Its compact design and user-friendly interface are intended for home use, offering convenience and reliability in glucose monitoring.
This system is supplied as a single-use, non-sterile device intended for personal use in home settings. It requires calibration and testing with designated test strips and control solutions. The device is FDA-cleared under Special 510(k) clearance (K121087) and is classified under the Clinical Chemistry advisory committee. No MRI safety information is specified, and storage conditions are not detailed in the provided data. Users should follow manufacturer instructions for proper operation and maintenance.
Frequently asked questions
Is the Contour Next USB Blood Glucose Monitoring System reusable or single-use, and how should it be handled after use?
The Contour Next USB Blood Glucose Monitoring System is designed for repeated use by the same individual—it is not a single-use device. However, the test strips and control solutions are intended for single-use only. After use, the meter itself should be cleaned according to the manufacturer’s instructions to maintain accuracy and hygiene. Since it is non-sterile, it is meant for home use only and should not be shared between patients.
What software compatibility does the Contour Next USB Blood Glucose Monitoring System support for data analysis?
The system includes a USB interface to transfer glucose monitoring data to compatible software for trend analysis and reporting. While the exact software partners aren’t detailed, the design emphasizes home-use convenience and real-time connectivity, allowing users to track patterns over time. Check Bayer Healthcare’s documentation for updated software recommendations.
How does the Contour Next USB Blood Glucose Monitoring System differ from other glucose meters in terms of its regulatory pathway?
This device follows the FDA’s Special 510(k) clearance pathway (K121087) under the Clinical Chemistry advisory committee, classified as a Non-Blood-Wetting (NBW) Blood Glucose Meter. The clearance was granted in 2012, and the device is deemed substantially equivalent to a predicate. This pathway is common for glucose meters, but the USB connectivity and software integration may distinguish its modern features from older models.
Are there any special storage instructions for the Contour Next USB Blood Glucose Monitoring System, or should it be stored with the test strips?
The provided data does not specify storage conditions for the meter itself. However, since it is a non-sterile, home-use device, it should be stored in a dry, clean environment away from extreme temperatures or moisture. Test strips and control solutions (if included) should follow Bayer Healthcare’s separate storage guidelines to ensure accuracy and shelf life. Always refer to the manufacturer’s instructions for full details.
Can the Contour Next USB Blood Glucose Monitoring System be used in clinical settings like hospitals or doctor’s offices?
The system is intended exclusively for home use by individuals managing diabetes. While it is FDA-cleared, its non-sterile design and lack of specified clinical protocols (e.g., infection control measures for shared use) make it unsuitable for hospital or office settings. Clinical environments typically require sterile or dedicated-use devices with additional validation.
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: Blutzuckermessgerät | CONTOUR®NEXT, BAYER HEALTHCARE CONTOUR NEXT USER MANUAL Pdf Download, CONTOUR® Blutzuckermesssysteme | Ascensia Diabetes Care …, BAYER HEALTHCARE CONTOUR NEXT USER MANUAL Pdf Download, Blutzuckermessgerät | CONTOUR®NEXT ONE
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K121087 | Class II | Active |
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Manufacturer
- Manufacturer
- Bayer Healthcare
Sources (1)
- FDA 510(k) K121087 24 fields · synced Oct 6, 2026