U.S. FDA Approval Clinical Study ISO:2013 Results EU Approval
Download – U.S. FDA approval letter
- UniStrip1 fulfills the stringent requirements of the U.S. FDA and on November 6, 2013 received 510 (k) clearance for marketing as a medical device Class 1 in the U.S.
- 510 (k) approval from the U.S. FDA is based upon a comparison of UniStrip1 with another medical product (reference product), which previously has been approved by the FDA.
- The manufacturer of UniStrip1 is subject to unannounced inspections from the U.S. FDA to determine compliance with quality system regulations.
Download – Clinical Study
- The study was conducted for the U.S. FDA and submitted for approval.
- The study compares the accuracy and precision between UniStrip1 test strips and OneTouch® Ultra® test strips with the following four OneTouch® Ultra® blood glucose meters: 1. OneTouch® Ultra®, 2. OneTouch® Ultra®2, 3. OneTouch® UltraMini® (UltraEasy® in Europe), 4. OneTouch® UltraSmart®
- The results show that UniStrip1 fulfills both the accuracy and precision requirements of the new ISO 15197:2013 standards:
- 100% of the measured values obtained with UniStrip1 in all four blood glucose meters lie within the zones A and B of the Consensus Error Grid (Parkes Error Grid)
- More than 95% of the measured values are within ± 15% (0.83 mmol/L) at concentrations of less than 5.6 mmol/L (within ± 15 mg/dl at concentrations of less than 100 mg/dl)
- At least 95% of the measured values are within ± 15% (0.83 mmol/L) at concentrations of 5.6 mmol/L or more (within ± 15 mg/dl at concentrations of 100 mg/dl or more)
Download – Summary
- Summary of the UniStrip1 clinical study results for measurement accuracy and precision as required by ISO 15197:2013
Download – EU Approval
- UniStrip1 test strips have been certified since April 8, 2014 by TÜV SÜD.
- The European Directive 93/42 / EEC (known as the Medical Device Directive or under the abbreviation MDD) defines the essential requirements to be met by both manufacturers and importers, before the CE marking can be applied to their products allowing these products to be legally sold in the European market.