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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 < 100 mg/dL and within ±15% for glucose concentrations ≥ 100 mg/dL). However, these specific numerical criteria and the detailed performance results are not provided in this summary.

Therefore, the table below will list the tests performed, and for "Reported Device Performance," it will indicate that the tests were conducted and their outcomes were deemed satisfactory by the manufacturer for substantial equivalence.

2. Sample Size Used for the Test Set and the Data Provenance:

The document does not explicitly state the sample sizes used for each of the non-clinical tests (e.g., for the ISO 15971 System Accuracy Evaluation). It also does not specify the country of origin of the data or whether the tests were retrospective or prospective. It only lists the types of tests performed.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

This information is not provided in the document. The studies listed are primarily non-clinical laboratory tests, which typically rely on reference methods (e.g., laboratory analyzers) rather than expert consensus for ground truth establishment.

4. Adjudication Method for the Test Set:

This information is not provided in the document. Given that the studies were non-clinical laboratory tests, adjudication methods like 2+1 or 3+1 (commonly used for subjective interpretations by multiple human readers) would not be applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical studies were conducted." The studies performed were non-clinical laboratory and bench tests.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Yes, all the listed studies were standalone performance evaluations of the UniStrip1™ Test Strips in conjunction with the specified blood glucose meters. There was no human-in-the-loop component in these non-clinical tests; they evaluated the device's inherent measurement capabilities.

7. The Type of Ground Truth Used:

The ground truth for the non-clinical tests would typically be established using reference laboratory methods or calibrated instruments as defined by the standards (e.g., ISO 15971, NCCLS EP documents). For instance, in a system accuracy evaluation, blood glucose values would be determined by a sophisticated laboratory analyzer, and these values would serve as the "ground truth" against which the UniStrip1™ Test Strips' measurements are compared.

8. The Sample Size for the Training Set:

The concept of a "training set" is relevant for machine learning algorithms. Blood glucose test strips are typically electrochemical or photometric devices, and while they involve internal calibration curves, they generally do not involve a "training set" in the sense of a machine learning algorithm. The document does not mention any artificial intelligence or machine learning components that would necessitate a training set. Therefore, this information is not applicable and not provided.

9. How the Ground Truth for the Training Set Was Established:

As explained in point 8, the concept of a "training set" as it pertains to machine learning is not applicable to this device. Therefore, the method for establishing ground truth for a training set is not provided.

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