Introduction of ISO 15197:2013
The ISO 15197:2013 standard revolutionizes the diabetic test strip market. It tightens accuracy requirements to ±15% and enforces stricter interference testing. This standard forces inferior technologies out.
Key Impacts
- Photometry Obsolescence: Electrochemical sensors replace older light-based sensors due to their inability to meet new precision standards.
- Chemistry Shift: Manufacturers replace GDH-PQQ enzymes with GDH-FAD and Mut. Q-GDH chemistries to address maltose interference.
- Market Consolidation: High R&D and manufacturing costs force low-cost generic manufacturers out of regulated markets.
- Regulatory Alignment: The EU and FDA adopt these standards, leading to the discontinuation of legacy product lines and migration to modern platforms.
References
- Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use: Guidance for Industry and Food and Drug Administration StaffSource
- System Accuracy Evaluation of 43 Blood Glucose Monitoring Systems for Self-Monitoring of Blood Glucose according to DIN EN ISO 15197Source
- Lot-to-Lot Variability of Blood Glucose Monitoring SystemsSource