History & Major Events
Evolution of diabetic test strips and key milestones in technology
Electrochemical vs. Photometric Detection
The evolution of diabetic test strips is a move from **photometric** detection, where a meter reads a color change on the strip, to **electrochemical*...
Electron Mediator Technologies
Electron mediators are the chemicals in electrochemical test strips that carry electrons from the glucose enzyme to the electrode, a job oxygen did in...
Evolution of Calibration (Coding)
Test strip calibration, or coding, matches a blood glucose meter to each batch of strips. We trace it from color charts and two-point calibration thro...
ISO 15197 Accuracy Standards Evolution
ISO 15197 is the international standard that sets accuracy and testing requirements for blood glucose monitoring systems used for self-testing. The fi...
US Market Leader Product Generations
LifeScan's OneTouch, Roche's Accu-Chek, Ascensia's Contour and Abbott's FreeStyle test strips each went through US product generations that FDA record...
Electron Transfer Mediators
**Electron Transfer Mediators** were the chemistry that let diabetic test strips move from clinical labs to home use. Early **First Generation** senso...
ISO 15197:2013 Accuracy Standards Evolution
How the ISO 15197 accuracy standard for blood glucose meters and test strips evolved from the 2003 edition to ISO 15197:2013, what its accuracy criter...
Mediator Chemistry and Electron Transfer
Diabetic test strips measure glucose by moving electrons from an enzyme to an electrode, and the molecule that carries those electrons defines each ge...
The Rise of White-Label and Generic Test Strips
White-label test strips are store-brand meter systems that manufacturers such as i-SENS and Trividia Health build and sell under retailer names, while...
Calibration Codes vs. No-Code Technology
The evolution from **Calibration Codes** to **No-Code Technology** took a common user error out of diabetic test strip use. Older meters had to be mat...
Enzyme Chemistries: GOx vs. GDH-PQQ vs. GDH-FAD
Diabetic test strips use glucose oxidase (GOx) or glucose dehydrogenase (GDH) paired with a PQQ, FAD or NAD cofactor, and each chemistry has different...
Third-Party Generic Strip Litigation
Third-party generic strip litigation in the United States centers on LifeScan's patent suits against the makers of GenStrip, a strip built for OneTouc...
Continuous Glucose Monitoring (CGM) Algorithms
Continuous Glucose Monitoring (CGM) relies on **algorithms** that turn a sensor's raw electrochemical signal into a glucose reading. They filter noise...
Evolution of Electron Mediators
Electron mediators carry electrons from the enzyme to the electrode in electrochemical diabetic test strips. This article dates how they changed, from...
Interoperability Standards (IEEE 11073)
In the evolution of blood glucose meters into connected devices, **ISO/IEEE 11073** is the family of interoperability standards for how personal healt...
Regulatory Pathways (510k) for Test Strips
Diabetic test strips and their meters reach the US market through the FDA 510(k) premarket notification pathway, as Class II glucose test systems show...
Third-Generation Direct Electron Transfer (DET)
Third-Generation **Direct Electron Transfer (DET)** glucose sensors aim to remove both oxygen (1st Gen) and artificial mediators (2nd Gen) from the re...