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extendsure lyophilized hba1c linearity controls
Canterbury Scientific
Summary: Extendsure Lyophilized HbA1c Linearity Controls are used to ensure the accuracy and reliability of HbA1c testing in laboratories. They are primarily used by clinical laboratory professionals.
FDA Clearance Information
Pathway
510K
Number
K071648 ↗
Decision Date
August 22, 2007
Product Code
JJX
Device Class
Class 1
Evidence
419 studies
The Extendsure Lyophilized HbA1c Linearity Controls were cleared via the FDA 510(k) pathway on August 22, 2007. Manufactured by Canterbury Scientific, this device is classified as a Class 1 product under the product code JJX.
What It Is
The Extendsure Lyophilized HbA1c Linearity Controls are quality control materials used in laboratory settings to verify the linearity and accuracy of HbA1c assays. These controls are lyophilized, meaning they are freeze-dried for stability and longevity, and are reconstituted with water before use. They help ensure that HbA1c measurements, crucial for diabetes management, are consistent and reliable across different testing platforms.
Clinical Applications
These controls are commonly used in clinical laboratories that perform HbA1c testing, which is critical for monitoring long-term glucose control in diabetic patients. They are particularly important in ensuring that the laboratory equipment is properly calibrated and that test results are accurate, which is essential for endocrinologists and primary care physicians managing diabetic patients. The device is suitable for use in hospital labs, reference labs, and point-of-care testing environments.
Indications for Use
The Extendsure Lyophilized HbA1c Linearity Controls are indicated for use in verifying the accuracy and linearity of HbA1c testing equipment. This is essential for ensuring that the test results used to manage diabetes are accurate and reliable.
Practical Considerations
These controls are typically provided in a range of concentrations to cover the clinically relevant range of HbA1c values. They are compatible with most HbA1c testing platforms. Reconstitution with water is required before use, and proper storage conditions should be maintained to ensure stability.
Related Literature
The linked study explored the chemical properties of Centaurium erythrea L. and its effects on carbohydrate and lipid metabolism in experimental diabetes. It found that the plant extract has potential antihyperglycemic and antilipidemic activities, which could be beneficial in managing diabetes. However, the study was conducted in an experimental setting, and further research is needed to confirm these effects in clinical practice.
Linked Studies (20)
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RCT|prospective|retrospective|case Series|other View Source →Frequently Asked Questions
What is Extendsure Lyophilized HbA1c Linearity Controls used for?
It is used to verify the accuracy and linearity of HbA1c testing equipment in laboratories.
What specialties typically use this device?
Clinical laboratory professionals, particularly those in endocrinology and primary care settings, use this device.
What are the FDA-cleared indications?
The device is indicated for verifying the accuracy and linearity of HbA1c assays, ensuring reliable diabetes management testing.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.