DIASCAN Blood Glucose Self-Monitoring Test Strips

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

510(k) Number

K872505 ↗

FDA Product Code

CGA

Device Class

Class II

Regulation

21 CFR Part 862.1345

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Diascan Blood Glucose Monitoring Test Strip

  Class II

  FDA 510(k) K915772 Active Cleared 14 Apr 1992

• Trueresult Blood Glucose System E4H01-81 Open recall

  Class II

  FDA 510(k) K080641 Active Cleared 19 Aug 2008

• TRUE2GO Blood Glucose System, Model F4H01-81 Open recall

  Class II

  FDA 510(k) K080710 Active Cleared 13 Aug 2008

• Prestige Lx Blood Glucose Test System

  Class II

  FDA 510(k) K992988 Active Cleared 24 Sep 1999

• Modification to Truetrack Smart System Blood Glucose Meter, Test Strips and Glucose Control

  Class II

  FDA 510(k) K040670 Active Cleared 25 Mar 2004

• Truebalance Blood Glucose System Open recall

  Class II

  FDA 510(k) K090495 Active Cleared 27 Mar 2009

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• What is the DIASCAN* Blood Glucose Self-Monitoring Test Strip used for?

  The DIASCAN* Blood Glucose Self-Monitoring Test Strip is intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and pancreatic islet cell carcinoma.

• How is the DIASCAN* Blood Glucose Self-Monitoring Test Strip supplied?

  The device is supplied as test strips for self-monitoring of blood glucose, designed for use by individuals outside of clinical settings to monitor their glucose levels.

• Is the DIASCAN* Blood Glucose Self-Monitoring Test Strip a single-use or reusable device?

  The DIASCAN* Blood Glucose Self-Monitoring Test Strip is intended for single-use only, as each strip is designed to be used once per glucose measurement to ensure accuracy and prevent contamination.

• What regulatory pathway was used for the DIASCAN* Blood Glucose Self-Monitoring Test Strip?

  The DIASCAN* Blood Glucose Self-Monitoring Test Strip received FDA 510(k) clearance under submission K872505, demonstrating substantial equivalence to a legally marketed predicate device.

• What class of medical device is the DIASCAN* Blood Glucose Self-Monitoring Test Strip?

  The DIASCAN* Blood Glucose Self-Monitoring Test Strip is classified as a Class II medical device under regulation number 862.1345, as indicated in its FDA 510(k) clearance documentation.