Gl Goodlife Series Blood Glucose Monitoring Sysmtem
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K113307 FDA 510(k)
- FDA Product Code
- LFR 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 GoodLife Series Blood Glucose Monitoring System is a portable, battery-powered device designed for the quantitative measurement of glucose in fresh capillary whole blood. It operates as a semi-automated or automated self-testing meter, incorporating test strips, reagents, and associated accessories such as lancets and control solutions. This system falls under the category of glucose dehydrogenase-based devices, enabling accurate monitoring of blood glucose levels for diabetes management.
The system is supplied as a reusable meter paired with single-use test strips and lancets, intended for home or clinical use. It is classified as a Class II medical device under FDA regulations (862.1345) and holds an FDA 510(k) clearance (K113307) with a decision date of July 27, 2012. The device is not MRI-safe, and storage conditions must adhere to manufacturer guidelines to maintain performance. Multiple model variants (e.g., AC-11, AC302) are authorized for commercial distribution.
Frequently asked questions
What is the GoodLife Series Blood Glucose Monitoring System used for?
The GoodLife Series Blood Glucose Monitoring System is designed for the quantitative measurement of glucose levels in fresh capillary whole blood. It uses glucose dehydrogenase-based technology to provide accurate readings, making it suitable for diabetes management in both home and clinical settings. This system helps users monitor their blood glucose levels consistently for better control and decision-making regarding their condition.
How is the GoodLife Series Blood Glucose Monitoring System supplied?
The system consists of a reusable meter paired with single-use test strips and lancets. This setup ensures that each test strip is used only once, maintaining accuracy and hygiene, while the meter itself is designed for repeated use. The system also includes control solutions and other accessories necessary for reliable blood glucose monitoring.
Is the GoodLife Series Blood Glucose Monitoring System sterile?
The single-use test strips and lancets are intended to be sterile for each use, reducing the risk of contamination and ensuring accurate results. The reusable meter itself is not sterile but is designed for clinical or home use where proper hygiene practices are followed. Always follow manufacturer guidelines for handling and storage to maintain performance and safety.
Are there different models of the GoodLife Series Blood Glucose Monitoring System?
Yes, the GoodLife Series includes multiple model variants, such as the AC-11 and AC302, which are authorized for commercial distribution. These variants may offer slight differences in features or specifications, but they all share the same core functionality of glucose dehydrogenase-based blood glucose monitoring. Check with the manufacturer or distributor for specific details on the model you require.
What storage conditions should be followed for the GoodLife Series Blood Glucose Monitoring System?
The GoodLife Series Blood Glucose Monitoring System must be stored according to the manufacturer’s guidelines to ensure optimal performance and accuracy. This typically includes keeping the meter and test strips in a cool, dry place, away from direct sunlight and extreme temperatures. Proper storage conditions help preserve the integrity of the test strips and the functionality of the meter, ensuring reliable results when used.
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: Gl Goodlife Series Blood Glucose Monitoring Sysmtem, AccessGUDID - DEVICE: GL GoodLife (00389154000198), Gl Goodlife Series Blood Glucose Monitoring Sysmtem, GLGoodLife - gl-diabetes.com, AccessGUDID - DEVICE: GL GoodLife Blood Glucose Monitoring System ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K113307 | Class II | Active |
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Manufacturer
- Manufacturer
- Hmd Biomedical Inc.
- FDA Applicant
- Hmd Biomedical, Inc.
Sources (1)
- FDA 510(k) K113307 24 fields · synced Oct 5, 2026