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Glucose Control Solution for TheraSense FreeStyle Blood Glucose Monitoring System is intended for use to verify the performance of the FreeStyle BGM System at multiple glucose levels within the reportable range. The Glucose Control Solution is intended for use by healthcare professionals and people with diabetes mellitus at home.

For In Vitro Diagnostic Use

Glucose Control Solution for TheraSense FreeStyle is a three-level, viscosityadjusted, aqueous liquid glucose control solution. Glucose Control Solution for TheraSense FreeStyle provides a convenient method of performing periodic QC checks for laboratories selecting to measure liquid QC material as a part of their circuits for laoving or am. The product is packaged in plastic bottles with dropper tips for application of the solution to test strips. The control has a red color to help users see the solution while dispensing onto a test strip.

Glucose Control Solution for TheraSense FreeStyle contains glucose values at three points within the reportable range and verify performance of the TheraSense FreeStyle BGM.

Glucose Control Solution for TheraSense FreeStyle is a non-hazardous aqueous solution containing no biological materials.

The Bionostics Glucose Control Solution for TheraSense FreeStyle is a multi-analyte control solution intended to monitor and evaluate the analytical performance of the TheraSense FreeStyle Blood Glucose Monitoring (BGM) system. It is a three-level, viscosity-adjusted, aqueous liquid glucose control solution.

Here's a breakdown of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of acceptance criteria with specific numerical thresholds for performance metrics. Instead, it lists the types of tests conducted to ensure specific performance requirements. Since this is a control solution, the "performance" is more about its stability and its ability to provide target glucose values for the BGM, rather than a diagnostic accuracy metric itself.

It's important to note that the document states "Tests were conducted to verify specific performance requirements" rather than providing the numerical results or the acceptance thresholds themselves. The implication is that these tests were successfully passed, indicating the device meets its intended performance characteristics for stability and providing appropriate glucose levels for QC.

2. Sample Sizes and Data Provenance:

• Test Set Sample Size: The document does not specify exact sample sizes for the "tests were conducted" bullet points (closed bottle stability, open stability, correlation, precision/range).
• Data Provenance: The studies were conducted by Bionostics, Inc. The document does not specify the country of origin of the data beyond the company's location in Devens, MA, USA. The studies are non-clinical, implying laboratory-based testing rather than patient data. They are retrospective in the sense that the testing was completed as part of the premarket notification.

3. Number of Experts and Qualifications for Ground Truth:

Not applicable. This device is a control solution, and its "ground truth" refers to its intrinsic chemical properties and the accuracy of its stated glucose values, not a diagnostic judgment by experts. The "ground truth" for the glucose concentration would be established through laboratory methods (e.g., gravimetric D-glucose as mentioned).

4. Adjudication Method for Test Set:

Not applicable. As described above, this is a non-clinical product.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. This is not an AI or diagnostic imaging device that involves human readers interpreting results.

6. Standalone (Algorithm Only) Performance:

Not applicable. This is a chemical control solution, not an algorithm. Its performance is evaluated based on its chemical stability and the accuracy of its assigned values when measured by the target BGM system. The document focuses on the control solution's characteristics rather than the BGM system's standalone performance.

7. Type of Ground Truth Used:

The ground truth for the glucose concentration in the control solutions would be established through laboratory analytical methods, specifically "correlation to gravimetric D-glucose." This refers to defining the true concentration of glucose by weighing it directly or using a highly accurate reference method.

8. Sample Size for Training Set:

Not applicable. This is a physical control solution, not an AI model that requires training data.

9. How Ground Truth for Training Set was Established:

Not applicable.

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