Blood Glucose Monitoring System 180, 182, GM280, GM280B
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K170143 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 Blood Glucose Monitoring System 180, 182, GM280, and GM280B are portable, handheld devices designed for self-monitoring of blood glucose levels. These systems fall under the category of in vitro diagnostic (IVD) devices, specifically for measuring glucose concentrations in capillary whole blood, aiding in the management of diabetes.
These systems are supplied as single-use or reusable components, depending on the model, and are intended for use in home healthcare settings. The devices are authorized under FDA 510(k) clearance and IVD Directive compliance, with no specific MRI safety restrictions noted. Storage requirements are standard for diagnostic devices, and the systems are distributed with test strips, lancets, and a meter for accurate glucose readings.
Frequently asked questions
Are these glucose monitoring systems designed for professional clinical use or home healthcare settings only?
These systems are explicitly designed for home healthcare settings to enable self-monitoring of blood glucose levels. While they are portable and handheld, their intended use aligns with patient self-testing rather than clinical laboratory or hospital environments, as noted in the description.
How do I know if the test strips, lancets, and meter are compatible with each other across the different models?
The GE Blood Glucose Monitoring System 180, 182, GM280, and GM280B are all part of the same product line from Bionime Corporation, meaning their test strips, lancets, and meters are designed to be interchangeable within the series for accurate glucose readings. However, users should verify compatibility by checking the manufacturer’s instructions or packaging to ensure the correct components are paired.
Are the lancets and test strips single-use, or can they be reused for multiple tests?
The lancets and test strips for these systems are single-use only, as is standard for blood glucose monitoring devices to ensure accuracy, hygiene, and safety. Reusing them could compromise results or introduce contamination risks, so users should replace them after each test.
What storage conditions should I follow to maintain the accuracy and performance of these devices?
The systems require standard storage conditions for diagnostic devices, which typically means keeping them in a cool, dry place (not exposed to extreme heat, moisture, or direct sunlight) and away from direct sunlight. Test strips and lancets should be stored according to the manufacturer’s instructions, often in sealed packaging until use, to preserve their integrity and accuracy.
What regulatory pathways have these devices undergone, and how does that affect their use?
These devices have been authorized through FDA 510(k) clearance (traditional pathway, classified under product code NBW) and comply with the In Vitro Diagnostic Device Directive (IVDD). This means they meet U.S. and EU regulatory standards for safety and performance, but their intended use remains self-monitoring of blood glucose in home healthcare settings, not clinical diagnosis or treatment.
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.
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 | K170143 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bionime Corporation
Sources (2)
- FDA 510(k) K170143 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026