History & Major Events
Evolution of diabetic test strips and key milestones in technology
Electrochemical vs. Photometric Detection
The evolution of diabetic test strips is defined by the transition from **Photometric** to **Electrochemical** detection. **Photometric technology**...
Electron Mediator Technologies
Electron mediators are critical chemical components in modern diabetic test strips that shuttle electrons from the glucose enzyme to the sensor electr...
Evolution of Calibration (Coding)
ISO 15197 Accuracy Standards Evolution
The evolution of ISO 15197 represents a critical tightening of safety and accuracy benchmarks for blood glucose monitoring systems. The original **ISO...
US Market Leader Product Generations
The US diabetic test strip market is defined by the product generations of four major manufacturers: LifeScan, Roche, Ascensia, and Abbott. **Key Ge...
Electron Transfer Mediators
The evolution of **Electron Transfer Mediators** was the critical innovation that allowed diabetic test strips to move from clinical labs to home use....
Enzyme Chemistries (GOx vs GDH-PQQ vs GDH-FAD)
The evolution of diabetic test strip chemistry has been driven by the need to balance **glucose specificity** with **oxygen independence**. * **GO...
ISO 15197:2013 Accuracy Standards Evolution
Mediator Chemistry and Electron Transfer
The evolution of diabetic test strips is defined by the shift from **Oxygen-dependent (1st Gen)** to **Mediator-based (2nd & 3rd Gen)** electron trans...
The Rise of White-Label and Generic Test Strips
The diabetic test strip market has shifted from a high-margin monopoly to a price-competitive landscape driven by the **Medicare Competitive Bidding P...
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. Origi...
Enzyme Chemistries: GOx vs. GDH-PQQ vs. GDH-FAD
The chemistry of diabetic test strips has evolved through three generations to balance accuracy and safety. **Glucose Oxidase (GOx)** was the original...
Third-Party Generic Strip Litigation
The diabetic test strip market is defined by a "razor-and-blades" model, leading to aggressive litigation between **Original Equipment Manufacturers (...
Continuous Glucose Monitoring (CGM) Algorithms
The efficacy of Continuous Glucose Monitoring (CGM) relies heavily on sophisticated **algorithms** that process raw electrochemical signals into accur...
Evolution of Electron Mediators
Interoperability Standards (IEEE 11073)
The transition of Blood Glucose Meters (BGMs) from standalone devices to connected IoT nodes is underpinned by the **ISO/IEEE 11073** family of standa...
Regulatory Pathways (510k) for Test Strips
The regulatory pathway for diabetic test strips in the US is governed by the **FDA 510(k) Premarket Notification** process for Class II devices. A cri...
Third-Generation Direct Electron Transfer (DET)
Third-Generation **Direct Electron Transfer (DET)** sensors represent the theoretical apex of enzymatic glucose sensing, eliminating the need for both...