(744 days)
The Unistrip1™ Test Strips are used with the OneTouch "Ultra", OneTouch" Ultra2", OneTouch" UltraMini and One-Touch UltraSmart meters purchased before October 2012, set at calibration code 49, for measuring glucose (sugar) in whole capillary blood. The Unistrip1™ is meant for self-testing of blood . glucose as an aid to monitor the effectiveness of diabetes control.
They are for single patient use only and should not be shared.
They are used to quantitatively measure glucose in fresh capillary whole blood samples taken from the finger, palm, or forearm.
Testing is done outside the body (in vitro diagnostic use).
They are indicated for use by people with diabetes in their home as an aid to monitor the effectiveness of diabetes control.
Not intended for the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates.
UniStrip1™ Test Strips allow alternate site testing (AST) from the fingertip, palm and/or the forearm. (Use of palm AST is not to be done with OneTouch Ultra meter). Alternative site testing should only be done during steady-state times (when glucose is not changing rapidly). Alternative site testing (AST) testing should only be done during steady-state times (when glucose is not changing rapidly).
The UniStrip1™ Test Strips are used with the OneTouch® Ultra®, OneTouch® Ultra2®, OneTouch® UltraMini® and QneTouch® UltraSmart® blood glucose monitoring systems. The UniStrip1™ test Strips is intended for use outside the body (in vitro diagnostic use) by people with diabetes using the OneTouch® Ultra®, OneTouch® Ultra2®, OneTouch® UltraMini® and OneTouch® UltraSmart® blood glucose monitoring systems as an aid to monitor the effectiveness of diabetes control. The UniStrip1™ Test Strips allow alternate site testing (AST) from the fingertip, palm and/or the forearm. (Use of palm AST is not to be done with OneTouch Ultra meter).
The UniStrip1™ Test Strip can only be used on the OneTouch®Ultra®, OneTouch®Ultra2®, OneTouch® UltraMini® and OneTouch® UltraSmart® meters purchased before October 2012. UniStrip1™ Test Strips are only for use with calibration code 49.
The UniStrip1™ Test Strips are intended for use with specific OneTouch® blood glucose monitoring systems to measure glucose in capillary whole blood. The device manufacturer, UniStrip Technologies, LLC, conducted several non-clinical studies to demonstrate the safety and effectiveness of the UniStrip1™ Test Strips.
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document does not explicitly state numerical acceptance criteria for each test. Instead, it lists the types of tests conducted (e.g., NCCLS EP5-A Precision Test, ISO 15971 System Accuracy Evaluation) and concludes that "no new issues of safety and effective have been raised." This implies that the device results met the established performance standards of these internationally recognized test protocols. For example, for an ISO 15971 System Accuracy Evaluation, typical acceptance criteria would involve a certain percentage of results falling within specific deviation ranges from a reference method (e.g., within ±15 mg/dL for glucose concentrations
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.