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RNA Medical® Brand Glucose and ß-Ketone Calibration Verification Controls are assayed materials for confirming the calibration and linearity of glucose and ß-ketone at the upper and lower limits of the reportable range and at three (3) points within the range. This product is for use with the Precision Xceed Pro Blood Glucose and ß-ketone Monitoring System, which uses Precision Xceed Pro Blood Glucose Test Strips and Precision Xceed Pro Blood B-Ketone Test Strips. It is not for use with the Precision PCx System or the i-STAT® 1 Analyzer, which use Precision PCx Test Strips, Precision PCx Plus Test Strips, or i-STAT 1 glucose cartridges.

RNA Medical Glucose and ß-Ketone Calibration Verification Controls is intended for use by healthcare professionals.

For In Vitro Diagnostic Use

RNA Medical Glucose and ß-Ketone Calibration Verification Controls is a five-level. viscosity-adjusted, aqueous liquid glucose and ß-ketone control linearity set optimized for use with the Abbott Diabetes Care Precision Xceed Pro™ Blood Glucose and B-Ketone Monitoring System using Precision Xceed Pro Blood Glucose Test Strips and Precision Xceed Pro Blood β-Ketone Test Strips. RNA Medical Glucose and β-Ketone Calibration Verification Controls provides a convenient method of performing periodic QC checks for laboratories selecting to measure liquid QC material as part of their quality assurance program. 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.

RNA Medical Glucose and β-Ketone Calibration Verification Controls contains glucose and ketone values at the lower and upper limits of reportable range as well as three points within the range and therefore, may be used to assess the linearity and calibration, or verify performance of the blood glucose and blood ketone systems listed on the package insert.

This material is comprised of an aqueous solution of glucose (0.03% - 0.40%), β-hydroxybutyrate (0.01% - 0.12%), and non-reactive ingredients (viscosity enhancing agent, dye, buffer, and preservative) prepared in five specific glucose and ketone concentrations. These controls contain no hazardous or human biological materials.

Acceptance Criteria and Study for RNA Medical Glucose and ß-Ketone Calibration Verification Controls

Based on the provided document, the "RNA Medical Glucose and ß-Ketone Calibration Verification Controls" is a control product used to assess the performance of a blood glucose and β-ketone monitoring system, not an AI device. As such, the typical metrics and study designs applicable to AI/ML medical devices (e.g., sensitivity, specificity, MRMC studies, standalone performance) are not relevant here.

Instead, the acceptance criteria and supporting studies focus on the stability and accuracy of the control solution itself, ensuring it provides reliable and consistent reference points for calibration verification and linearity testing.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list "acceptance criteria" in a quantitative table format for performance metrics. Instead, it describes "specific performance requirements" that were verified. The reported device performance is presented as the intended target values for the different levels of the control.

Here's an interpretation of the implied acceptance criteria and the device's reported performance (target values):

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

• Sample Size for Test Set: The document does not specify a "test set" sample size in terms of patient data or clinical samples, as this is a control solution, not a diagnostic device directly analyzing patient samples. The testing involved multiple measurements of the control solution itself. The exact number of runs or samples per stability or precision study is not detailed in this summary.
• Data Provenance: Not applicable in the context of patient data for a control solution. The data would originate from laboratory testing performed internally by the manufacturer (Bionostics, Inc.) during product development and validation. The country of origin for the testing would presumably be the USA (Devens, MA), where the company is located. The studies would be prospective in nature, as they involve testing the newly developed control solution.

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

• Number of Experts: Not applicable. For a control solution like this, the "ground truth" for the test set is established by precise chemical formulation and analytical testing, not by expert interpretation of images or clinical cases.
• Qualifications of Experts: N/A. The "experts" involved would be analytical chemists, quality control specialists, and metrologists responsible for formulating the controls and verifying their concentrations using established laboratory methods and traceable standards.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Adjudication typically refers to resolving discrepancies between multiple human readers or between human readers and an AI system for clinical assessments. For a chemical control, the "truth" is determined by objective analytical measurements and verified against established chemical standards to ensure the stated concentration levels are correct.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (especially those involving image interpretation or clinical decision-making) where human performance is compared to human performance with AI assistance. The RNA Medical Glucose and ß-Ketone Calibration Verification Controls are calibration and linearity controls, not a diagnostic device.

6. Standalone (Algorithm Only) Performance Study

• Standalone Performance Study: No, a standalone performance study was not done. This type of study is relevant for AI algorithms to assess their performance without human intervention. The device in question is a chemical control solution, not an algorithm.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth for the control solution's values (glucose and ß-ketone concentrations) is established through analytical chemistry and metrology. This involves precise formulation and quantitative measurement using highly accurate reference methods and traceable standards to determine the exact concentration of glucose and ß-hydroxybutyrate in each level of the control. The manufacturer refers to an internal document "EDMS014536 Rev. 001, Summary of Expected G3CH And Ketones II Values for Bionostics Calibration Verification Control Solutions," which would contain these detailed analytical ground truth values.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device is a chemical control solution, not an AI/ML algorithm that requires a "training set" of data.

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

• How Ground Truth for Training Set Was Established: Not applicable. As there is no training set for an AI algorithm, there is no ground truth to be established for it. The ground truth for the control product itself is established through precise chemical formulation and analytical validation during manufacturing.

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