Yes! UniStrip1 blood glucose test strips are the first generic test strips for the LifeScan OneTouch Ultra Family of Blood Glucose Meters (OneTouch Ultra, Ultra2, UltraEasy and UltraSmart), which fulfill the strict regulatory requirements of the U.S. FDA (pharmaceutical and medical device regulatory authority in the United States, similar to the BfArM Federal Institute for Drugs and Medical Devices in Germany) and are approved for use in the European Union (CE marked).
UniStrip1 blood glucose test strips are manufactured by a company other than the blood glucose meter manufacturer. The OneTouch Ultra Family of Blood Glucose Meters are manufactured and marketed by LifeScan Inc., a Johnson & Johnson Company. UniStrip1 blood glucose test strips are manufactured by OK Biotech Co., Ltd. and marketed by Weatherfield Management GmbH in Germany.
An independent study, which was specifically required for regulatory approval by the U.S. FDA, confirmed that the accuracy of UniStrip1 blood glucose test strips is at least equal to the accuracy of the original test strip.
UniStrip1 blood glucose test strips already fulfill most of the new ISO 2013 Standards, especially testing accuracy and precision. The DIN EN ISO 15197:2013 certification for full compliance is currently in process with TÜV Süd and completion is expected before December 2015.
UniStrip1 blood glucose test strips are approved for use with the following blood glucose meters of the OneTouch® Ultra® Family of Blood Glucose Meters:
The date of manufacture of the blood glucose meter is irrelevant.
Yes, with the first use of UniStrip blood glucose test strips you must enter calibration code 49.
Proceed as follows:
1. Insert the UniStrip1 blood glucose test strip into your existing LifeScan OneTouch Ultra®, Ultra2™, or UltraEasy® UltraSmart® meter to turn on the meter.
2. Check that the code displayed on the meter matches the code on the UniStrip1 test strip vial. If the codes do not match, use the buttons on the meter to adjust the code until these match.
3. Once the code is set wait until a drop appears in the display. You are now ready to begin testing.
4. When using a new vial of UniSrip1 blood glucose test strips, perform a control solution test as usual with the UniStrip1 Control Solution.
The blood glucose test strips are used for the quantitative measurement of glucose in fresh capillary whole blood obtained from either the fingertip, palm or forearm. UniStrip1™ blood glucose test strips are for single use for an individual patient. They may not be re-used and not be shared with other patients.
The measurement is performed exclusively outside the body (in vitro diagnostic use). The test strips are intended for use by people with diabetes in their personal environment and for health professionals and serve as an aid for monitoring the effectiveness of diabetes therapy. They are not intended for the diagnosis of or screening of diabetes mellitus or use in neonates.
Typically, the blood glucose measurement is performed in fresh capillary whole blood obtained from the fingertip. UniStrip1™ blood glucose test strips allow for blood glucose tests to be performed at alternative test sites [Alternate Site Testing (AST)*] such as on the palm and forearm. Blood glucose testing on alternative test sites (AST) should be performed only during a state of equilibrium, i.e., when the blood glucose level is not subject to rapid change. UniStip1 blood glucose test strips use a very small amount of blood 5 µl and deliver the measurement results within 5 seconds.
* Palmar AST should not be performed with the OneTouch® Ultra® Meter.
YES. Blood glucose test strips do not require a prescription. If your insurance company has reimbursed your LifeScan OneTouch Ultra® blood glucose test strips, then it will also reimburse UniStrip1 blood glucose test strips. UniStrip1 blood glucose test strips can be either obtained with a prescription or purchased out-of-pocket in every pharmacy. The pharmacy can order UniStrip1 blood glucose test strips either via the pharmaceutical wholesaler or directly from the distributor Weatherfield Management GmbH.
YES. The German pharmaceutical central number/reimbursement code (PZN) is 11001103.