This 510(k) Substantial Equivalence Determination Decision Summary Assay features a comparison study performed by Shasta Technologies, LLC that shows GenStrip50 delivers same results as OneTouch Ultra test strips. FDA approved the study results clearing GenStrip50 as a generic alternative for OneTouch Ultra.
GenStrip50 blood glucose test strip is a generic alternative to the One Touch Ultra test strips. GenStrip50 delivers precise glucose readings at much lower costs. GenStrip50 test strips are safe and simple to use, approved by the FDA, and works like Ultra strips with the same sample size and same fast results.
Shasta Technologies performed several tests using GenStrip50 and OneTouch Ultra, Ultra 2, and UltraMini meters purchased before July 2010. Three GenStrip test strip calibration codes (10, 13, and 4) were used in each of the performance evaluations. PharaTech studies show that there is no difference in performance or technology between meters made before or after 2010.
To assess system accuracy, results from the GenStrip50 test strips and the OneTouch Ultra, Ultra2 and UltraMini meters were compared to a reference method, YSI 2300D Glucose Analyzer. Results were analyzed by comparing blood glucose results from the GenStrip50 test strip obtained by lay-users with capillary samples from fingerstick, forearm and palm to the YSI results. The results of the study supported the Shasta’s claimed glucose measurement range of 20-600 mg/dL. The samples used in the study ranged from 59-521 mg/dL as measured by YSI. Click here to see the study details.
The results of this study supported a substantial equivalence decision by FDA that GenStrip50 test strips with calibration codes 4, 10 and 13 are for use with OneTouch Ultra, Ultra2 and UltraMini Meter purchased before July 2010.
GenStrip50 Test Strips are for use with OneTouch Ultra, Ultra2 and UltraMini Meters. They are used to quantitatively measure glucose in fresh capillary whole blood samples taken form the finger, forearm or palm. Testing is done outside the body (in vitro diagnostic use). They are indicated for use by individuals with diabetes in their home as an aid to monitor the effectiveness of diabetes control.
- Minimal, Smart, and Sleek Design
- Alternate site testing
- Easy-Fill window makes it easy to see when blood sample is ready
- GenStrip50 requires the same tiny sample size as leading brand name test strips
- Easy to handle size for easy removal from with mouth vial
- GenStrip50 delivers the same fast results that you have come to expect
- Offers safe and accurate testing at the a price you can afford
- Made in the USA