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RNA1c Control for NycoCard HbA1c is intended for use to verify the performance of the Axis-Shield NycoCard HbA1c reader with normal and elevated glycosylated hemoglobin levels within the reportable range.

RNA1c Control for NycoCard HbA1c is intended to be used to monitor and evaluate the analytical performance of the Axis-Shield NycoCard HbA1c reader for the measurement of glycosylated hemoglobin. The use of quality control materials is indicated as an objective assessment of the precision of methods and techniques in use and is an integral part of good laboratory practice. The two levels of controls allow performance monitoring within the clinically important range.

For In Vitro Diagnostic Use

Glycosylated Hemoglobin (HbA1c) is a human hemoglobin A (HbA0) with glucose irreversibly bound to the N-terminal valine of the beta-chain. %HbA1c is the percentage of glycolsylated hemoglobin molecules as a percentage of the total hemoglobin concentration.

%HbA1c is quantified on medical devices by turbidimetric inhibition immunoassay (TINIA), ion-exchange HPLC, boronate affinity HPLC or gel electrophoresis.

The Axis-Shield NycoCard reader determines HbA1c concentration by the boronate affinity test principle and hemoglobin concentration photometrically. Using the values obtained for each of these two analytes, the percentage of the total hemoglobin that is glycated is calculated and reported as HbA1c%.

RNA1c Control for NycoCard HbA1c is a two-level, glycated bovine hemoglobin liquid control solution with dyed polystyrene beads to provide the appropriate total hemoglobin value. The concentration of dyed beads and glycated hemoglobin are optimized for the Axis-Shield NycoCard reader to provide measurement values for HbA1c equivalent to the predicate device, Primus Liquid Control for GHb/A1c.

RNA1c Control for NycoCard HbA1c provides a convenient method of performing periodic QC checks for laboratories selecting to measure liquid QC material as a part of their quality assurance program. The product is packaged in a glass bottle.

RNA1c Control for NycoCard HbA1c is a minimally hazardous liquid control solution containing no human biological materials and requires no reconstitution prior to use.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Bionostics RNA1c Control for NycoCard HbA1c device:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes a control device, not a diagnostic device with performance metrics like sensitivity, specificity, or accuracy for diagnosing a condition. Instead, the "performance" of a control device relates to its stability and its ability to correlate with a predicate control device.

Therefore, the "acceptance criteria" here are drawn from the "Summary of non-clinical tests" and the "Comparison of Technological Characteristics." The reported device performance is then how the new device meets those characteristics or stability claims.

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

The document does not specify particular "test sets" in the context of individual patient samples. For a control device, the "test set" would refer to the number of control units tested for stability, correlation, and precision.

• Sample Size for Stability: Not explicitly stated (e.g., how many vials were tested over the 12-month period for closed bottle stability or 30-day period for opened bottle stability).
• Sample Size for Correlation: Not explicitly stated (e.g., how many measurements were taken with the new control vs. the predicate).
• Data Provenance: The studies are described as "non-clinical tests" conducted by "Bionostics, Inc." (Devens, MA, USA). The data is retrospective in the sense that these tests were performed prior to submission, but they are directly evaluating the manufactured product to establish its performance characteristics under controlled conditions. This is not patient-data driven but product-performance driven.

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

This is not applicable to this type of device and study. The "ground truth" for a control material is its chemical composition and its measured value when run on a specific instrument. This is established through analytical chemistry and instrumentation validation, not expert consensus on patient data.

4. Adjudication Method for the Test Set

Not applicable. There is no ambiguous patient data or image interpretation requiring adjudication by experts. The "ground truth" is analytical.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This is a quality control material, not a diagnostic device based on human interpretation or AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a quality control material, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on:

• Analytical Chemistry and Manufacturing Specifications: The known concentration of glycated bovine hemoglobin and dyed polystyrene beads in the control solution.
• Reference Method/Predicate Device Comparison: The established performance and values of the predicate device (Primus Liquid Control for GHb/A1c) on the Axis-Shield NycoCard reader serve as a reference for equivalency in the correlation studies.

8. The Sample Size for the Training Set

Not applicable. This is a control material, not a machine learning model. There is no concept of a "training set" in this context.

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

Not applicable for the same reason as above.

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