GlucoSure HT Plus Blood Glucose Monitoring System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K202885 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 GlucoSure HT Plus Blood Glucose Monitoring System is a Blood Glucose Monitoring Device designed to measure glucose levels quantitatively in blood samples. It is intended for use in the diagnosis and management of carbohydrate metabolism disorders, including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, as well as monitoring for pancreatic islet cell carcinoma.
This system is supplied as a reusable device with single-use test strips, featuring an underfill detection mechanism to prevent erroneous readings from insufficient samples. It operates in clinical and home healthcare settings, adheres to FDA 510(k) clearance (K202885) and In Vitro Diagnostic Device (IVDD) regulations, and requires proper storage to maintain accuracy and sterility. The system includes a minimal blood sample requirement of 0.5 µL per test.
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: GlucoSure HT Plus Blood Glucose Monitoring System, PDF GlucoSure HT Plus DM-0724-20240801 - apexbio.com, K202885 - GlucoSure HT Plus Blood Glucose Monitoring System
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 | K202885 | Class II | Active |
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Manufacturer
- Manufacturer
- Apex Biotechnology Corp.
Sources (2)
- FDA 510(k) K202885 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 18, 2026