Nova Max Plus Blood Glucose and B-Ketone Monitor System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K091547 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 Nova Max Plus Blood Glucose and B-Ketone Monitor System is a diagnostic device designed for the self-monitoring of blood glucose and ketone levels. It allows users to perform both glucose and ketone testing using a single meter, providing glucose results in five seconds and ketone results in ten seconds.
This system is intended for use by people with diabetes to assist in the management of their condition. The device is authorized under FDA 510k clearance and is supplied as a meter, with control solutions available for quality testing.
Frequently asked questions
What is the primary purpose of the Nova Max Plus monitor system?
The Nova Max Plus system is a diagnostic device intended for the self-monitoring of blood glucose and ketone levels. It is designed to assist individuals with diabetes in the management of their condition by providing rapid test results.
How quickly does the Nova Max Plus system provide test results?
The system provides blood glucose results in five seconds and blood ketone results in ten seconds, allowing for efficient testing using a single meter.
How is the Nova Max Plus system supplied and how is quality testing performed?
The system is supplied as a meter, and Nova Max Plus B-Ketone control solutions are available for performing quality testing to ensure the device is functioning correctly.
What is the regulatory status of the Nova Max Plus monitor system?
The Nova Max Plus Blood Glucose and B-Ketone Monitor System is authorized under FDA 510k clearance, which indicates it has been found substantially equivalent to legally marketed predicate devices.
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: Nova Max® Plus Glucose/Ketone | Nova Biomedical, Nova Max Plus | American Diabetes Association, Amazon.com: Nova Max Plus Glucose Meter : Health & Household, Nova Max Plus Glucose & Ketone Meter - Diabetic Outlet
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K091547 | Class II | Active |
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Manufacturer
- Manufacturer
- Nova Biomedical Corp.
Sources (1)
- FDA 510(k) K091547 24 fields · synced Oct 6, 2026