Glucocard 01 Blood Monitoring System

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Arkray Glucocard 01 Blood Monitoring System

510(k) Number

K073416 ↗

FDA Product Code

CGA

Device Class

Class II

Regulation

21 CFR Part 862.1345

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Assure Platinum and Glucocard Vital Blood Glucose Monitoring Systems

  Class II

  FDA 510(k) K091102 Active Cleared 23 Oct 2009

• Arkray Diabetes Data Management Software (Smbg Viewer)

  Class II

  FDA 510(k) K093819 Active Cleared 9 Jun 2010

• Glucocard 01-Mini Blood Glucose Monitoring System, Model 73110

  Class II

  FDA 510(k) K082417 Active Cleared 21 Oct 2008

• Assure Pro Blood Glucose Monitoring System, Model 46001

  Class II

  FDA 510(k) K090332 Active Cleared 14 Aug 2009

• Glucocard X-Meter Blood Glucose Monitoring System

  Class II

  FDA 510(k) K063771 Active Cleared 9 Aug 2007

• Assure Platinum Blood Glucose Monitoring System

  Class II

  FDA 510(k) K092104 Active Cleared 24 Nov 2009

See all devices from Arkray Factory USA, Inc. →

• What types of blood samples can the Glucocard 01 Blood Monitoring System measure, and why is this important for users?

  The Glucocard 01 is designed specifically for capillary whole blood samples, such as those obtained from a fingerstick. It is not intended for serum, plasma, or venous whole blood. This distinction is critical because glucose levels in whole blood differ from those in plasma or serum due to the presence of red blood cells, which can affect measurement accuracy. Clinicians and patients must ensure the correct sample type is used to avoid inaccurate readings.

• Is the Glucocard 01 Blood Monitoring System intended for reuse, or is it meant for single-use only? How does this impact clinical workflow?

  The Glucocard 01 is explicitly designed for single-use only, meaning each test strip and associated components are intended for one measurement. This design reduces the risk of cross-contamination and ensures consistent performance. Clinicians should follow the manufacturer’s instructions to avoid reuse, as this could compromise sterility, accuracy, and regulatory compliance.

• What regulatory pathways has the Glucocard 01 Blood Monitoring System undergone, and what does this mean for healthcare providers?

  The device has received FDA 510(k) clearance and complies with In Vitro Diagnostic Device Directive (IVDD) requirements, classifying it as a Class II medical device. This means it has undergone rigorous review by regulatory authorities to ensure safety, performance, and accuracy for self-monitoring of blood glucose in home or clinical settings. Providers can rely on its compliance with these standards for reliable diagnostic use.

• How should the Glucocard 01 Blood Monitoring System be stored, and why is proper storage important?

  The system follows standard sterile procedures for point-of-care diagnostic devices, though specific storage instructions are not detailed in the provided data. Generally, such devices require protection from extreme temperatures, moisture, and direct sunlight to maintain accuracy and sterility. Proper storage ensures the device remains functional and safe for use, preventing degradation of components like test strips or the meter itself.

• What is the primary method used by the Glucocard 01 to measure glucose levels, and how does this affect its performance?

  The device employs the glucose oxidase method, a biochemical process that converts glucose into gluconic acid and hydrogen peroxide, generating an electrical signal proportional to glucose concentration. This method is widely recognized for its accuracy and reliability in measuring glucose in whole blood, making it suitable for diabetes management. The system’s performance depends on this validated chemical reaction, ensuring consistent and clinically relevant results.