Becton Dickinson Logic Blood Glucose Monitoring System

• • Terminated Z-0763-04 FDA Unclassified (pre-2012) ·initiated 29 Jan 2004

  39 lots of BD Test strip may produce an increased frequency of E-3 messages when used during blood glucose testing.

• • Terminated Z-1221-03 FDA Unclassified (pre-2012) ·initiated 23 Jul 2003

  Test Strips may not be meeting specifications at the lower range of glucose values.

510(k) Number

K022581 ↗

FDA Product Code

NBW

Device Class

Class II

Regulation

21 CFR Part 862.1345

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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• What is the Becton Dickinson Logic Blood Glucose Monitoring System used for?

  The Becton Dickinson Logic Blood Glucose Monitoring System is a home-use diagnostic device intended for patients with diabetes mellitus to monitor blood glucose levels in a non-clinical setting by measuring glucose concentration from capillary blood samples applied to a test strip.

• How does the Becton Dickinson Logic Blood Glucose Monitoring System measure glucose levels?

  The device utilizes amperometric biosensor technology to measure glucose concentration by detecting an electrical current generated from the reaction between blood glucose and reagents on the test strip when a 0.3 µL capillary blood sample is applied.

• Is the Becton Dickinson Logic Blood Glucose Monitoring System supplied as a home-use device?

  Yes, the device is supplied as a blood glucose monitor specifically designed for home use, as stated in the device description and authorization details, and is intended for patients to use outside of clinical environments.

• What regulatory authorization does the Becton Dickinson Logic Blood Glucose Monitoring System have?

  The device is authorized under FDA 510(k) clearance K022581, which was granted on October 9, 2002, following a traditional submission process and found to be substantially equivalent to a predicate device.