Glucosure Star Blood Glucose Monitoring System, Model AS90000E1
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K073648 FDA 510(k)
- FDA Product Code
- CGA 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 Star Blood Glucose Monitoring System, Model AS90000E1, is a blood glucose monitoring device classified under the Glucose Oxidase, Glucose category. It employs electrochemical biosensor technology to measure glucose concentration in whole blood, providing quantitative results for diabetes management.
This portable, battery-operated system is designed for use by individuals with diabetes and healthcare professionals. It operates via capillary action, drawing blood into a test strip for rapid measurement—results are displayed within six seconds. The device is single-use, non-sterile, and intended for in-home or clinical settings. Authorized under FDA 510(k) and IVDD compliance, it adheres to regulatory standards for Class II medical devices (FDA classification).
Frequently asked questions
What types of settings can the Glucosure Star Blood Glucose Monitoring System be used in, and why is this important for users?
The Glucosure Star Blood Glucose Monitoring System is designed for use in both in-home and clinical settings. This flexibility is important because it allows individuals with diabetes to monitor their glucose levels conveniently at home while also ensuring healthcare professionals can rely on it for accurate measurements in clinical environments. The device’s portability and ease of use make it suitable for routine self-monitoring or professional assessments.
How quickly does the Glucosure Star provide results, and what does this mean for a patient’s daily management of diabetes?
The Glucosure Star delivers quantitative glucose results within six seconds after drawing blood via capillary action. This rapid turnaround is critical for patients managing diabetes, as it enables timely adjustments to diet, medication, or activity levels, reducing the risk of hypoglycemia or hyperglycemia. Quick results also make it practical for frequent monitoring throughout the day.
Is the Glucosure Star Blood Glucose Monitoring System reusable, and if not, what does this mean for cost and convenience?
The Glucosure Star is explicitly designed as a single-use device, meaning each test strip and measurement is intended for one-time use only. This design choice ensures accuracy and hygiene, as reuse could introduce contamination or inaccurate readings. For users, this means regular restocking of test strips is necessary, which may impact long-term costs, but it also eliminates concerns about cross-contamination or device degradation over time.
What does the non-sterile classification mean for users of the Glucosure Star, and how should they handle the device?
The Glucosure Star is classified as non-sterile, meaning it is not intended for invasive procedures or sterile environments like surgical settings. For users, this means proper hygiene practices are essential—such as cleaning the puncture site with alcohol swabs before testing—to minimize infection risks. It is not suitable for use in sterile clinical procedures but remains appropriate for routine blood glucose monitoring in non-sterile environments like homes or outpatient clinics.
What regulatory pathways has the Glucosure Star followed, and what does this indicate about its compliance and safety standards?
The Glucosure Star has been authorized through FDA 510(k) clearance and IVDD (In Vitro Diagnostic Device Directive) compliance, indicating it meets stringent regulatory standards for Class II medical devices in the U.S. and European markets. This approval process ensures the device’s safety, performance, and equivalence to predicate devices, providing confidence in its reliability for clinical and home use. The Clinical Chemistry advisory committee review further underscores its validation for accurate glucose measurement.
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 Star Blood Glucose Monitoring System, Model As90000e1 ..., APEXBIO GLUCOSURE STAR USER MANUAL Pdf Download, Apexbio GlucoSure STAR Manuals | ManualsLib, GlucoSure STAR Blood Glucose Monitoring System Owner's Manual
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 | K073648 | Class II | Active |
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Manufacturer
- Manufacturer
- Apex Biotechnology Corp.
Sources (2)
- FDA 510(k) K073648 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 18, 2026