History & Major Events

Calibration Codes vs. No-Code Technology

The transition from Calibration Codes to No-Code Technology represents a critical evolution in diabetic test strip safety and usability. Originally, manufacturing variations in enzyme activity and electrode surface area required users to manually input batch codes or insert chips to calibrate the meter. This reliance on human intervention resulted in high error rates (up to 25%), leading to dangerous insulin dosing errors.

Modern "No-Code" systems eliminate this risk through two primary methods: Auto-Coding, where the strip transmits calibration data to the meter via resistive or digital contact patterns on the electrode tail; and Universal Calibration, where manufacturing tolerances are tightened so severely that batch-to-batch variation is negligible. This shift was driven by the need to meet stricter ISO 15197 accuracy standards and reduce hypoglycemia risks associated with miscoded meters.

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Calibration Codes vs. No-Code Technology

Introduction

Diabetic test strips have come a long way! They used to require manual input of batch codes or chip insertion, leading to a whopping 25% error rate. This caused dangerous insulin dosing mistakes.

Ditching Calibration Codes

Manufacturing variations needed calibration, but humans made mistakes. No-Code Technology saves the day! It uses two methods: Auto-Coding and Universal Calibration.

  • Auto-Coding: Strips send calibration data to meters via special contact patterns.
  • Universal Calibration: Manufacturers tighten tolerances, making batch variations negligible.

Driving Change

Stricter ISO 15197 standards drove this shift. It reduces hypoglycemia risks from miscoded meters.

The Bottom Line

No-Code Technology makes diabetic test strips safer and easier to use. It's a game-changer!

References

  1. ISO 15197:2013 - In vitro diagnostic test systems -- Requirements for blood-glucose monitoring systems for self-testing in managing diabetes

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