GlucoLeader Enhance 2 Blood Glucose Monitoring System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K212248 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 GlucoLeader Enhance 2 Blood Glucose Monitoring System is a blood glucose meter classified as a Blood Glucose Monitoring Device (NBW product code) under FDA and IVDD regulatory frameworks. It is designed to quantitatively measure glucose concentrations in capillary and venous whole blood, providing results compliant with ISO 15197:2013 standards for accuracy and reliability.
This system is intended for single-use per patient and delivers results in less than five seconds. It features an 800-test memory with date and time tracking, adjustable averaging intervals (7, 14, 21, or 28 days), and automatic power-saving shutoff after three minutes of inactivity. Supplied as a complete monitoring solution, it is regulated under FDA 510(k) clearance (K212248) and IVDD compliance.
Frequently asked questions
What types of blood samples can the GlucoLeader Enhance 2 measure, and how quickly does it provide results?
The GlucoLeader Enhance 2 is designed to measure glucose concentrations in both capillary and venous whole blood. It delivers accurate results in less than five seconds per test, making it suitable for quick clinical or home monitoring.
Is the GlucoLeader Enhance 2 intended for single-use or repeated use, and how many tests can it store?
The GlucoLeader Enhance 2 is intended for single-use per patient, meaning each device is meant to be used once. However, it includes an 800-test memory to store results, allowing for tracking of glucose levels over time with a new device for each patient.
What features does the GlucoLeader Enhance 2 include to help manage and track blood glucose readings?
The device offers date and time tracking for each test result, adjustable averaging intervals (7, 14, 21, or 28 days) to monitor trends, and an automatic power-saving function that turns off after three minutes of inactivity to conserve battery life.
How is the GlucoLeader Enhance 2 regulated, and which regulatory bodies have approved it?
The GlucoLeader Enhance 2 is regulated under the FDA’s 510(k) clearance pathway (K212248) and complies with the In Vitro Diagnostic Device Directive (IVDD). It is classified as a Blood Glucose Monitoring Device (NBW product code) and is intended for use in both clinical and home settings.
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: GlucoLeader | | Enhance | NS101 - HMD Biomedical, HMD Biomedical GlucoLeader Enhance 2 Blood Glucose Monitoring System ..., GlucoLeader Enhance 2 Blood Glucose Monitoring System, HMD BioMedical | GlucoLeader | Diabetes Care
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 | K212248 | Class II | Active |
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Manufacturer
- Manufacturer
- Hmd Biomedical Inc.
- FDA Applicant
- Hmd Biomedical, Inc.
Sources (2)
- FDA 510(k) K212248 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026