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The DRI® Hemoglobin A1c Assay is an in vitro reagent system for the quantitative determination of Hemoglobin A1c in human whole blood using automated clinical chemistry analyzers. It is intended to aid in monitoring long-term blood glucose control in individuals with diabetes mellitus.

The DRI® Hemoglobin A1c Calibrators are intended for use in the calibration of the DRI® Hemoglobin A1c Assay in human whole blood.

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DRI Hemoglobin A1c Assay kit contains reagent 1, 2a, 2b and a hemolysis buffer. All are in liquid format.

DRI Hemoglobin A1c Calibrator kit contains four lyophilized positive calibrators with different hemoglobin Dr. Hemogrobin ATC Galibrator int colution that serves as negative hemoglobin calibrator.

This document describes the DRI® Hemoglobin A1c Assay, a diagnostic device for measuring HbA1c levels in human whole blood. The submission focuses on demonstrating substantial equivalence to a predicate device, the Tosoh G7 Automated High Performance Liquid Chromatography (HPLC) Analyzer.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a separate table. However, the "Performance" table summarizes the results of the study, which can be interpreted as demonstrating the device meets the expected performance for an HbA1c assay. The implicit acceptance criterion for this 510(k) submission is substantial equivalence to the predicate device, implying that the performance metrics of the new device are comparable or statistically equivalent within acceptable ranges to the predicate.

The "acceptance criteria" are implicitly met if the reported performance supports the claim of substantial equivalence to the Tosoh G7 HPLC Analyzer, which is NGSP certified.

2. Sample size used for the test set and the data provenance:

• Precision Test Set Sample Size: n=80 (for both normal and elevated HbA1c samples).
• Method Comparison Test Set Sample Size: n=80.
• Data Provenance: Not explicitly stated regarding country of origin or specific demographics, but the study follows current guidance (NGSP and NCCLS), implying standard clinical laboratory practices. The study is implicitly retrospective in the sense that samples would have been collected and then tested with both devices, rather than a prospective cohort study for device evaluation.

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. For a diagnostic assay, "ground truth" is typically established by a reference method with known accuracy. Here, the predicate device (Tosoh G7 Automated HPLC Analyzer) is presented as the reference method, especially given its NGSP certification and use for establishing traceable results to the DCCT. The document doesn't mention expert interpretation of results, but rather direct comparison to the predicate's quantitative output.

4. Adjudication method for the test set:

This information is not applicable as there is no mention of human adjudication for the test results. The comparison is quantitative, machine-to-machine, against the predicate device.

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:

This is not applicable. The device is an in vitro diagnostic assay, not an AI-assisted imaging or diagnostic tool requiring human reader interpretation. No MRMC study was performed.

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

Yes, the study primarily demonstrates the standalone performance of the DRI® Hemoglobin A1c Assay system. It evaluates the assay's performance characteristics (limit of detection, precision, linearity, interference) and its agreement with a predicate reference method. There is no "human-in-the-loop" aspect to the analytical performance itself; the device provides a direct quantitative measurement.

7. The type of ground truth used:

The ground truth for the method comparison study is established by the predicate device, the Tosoh G7 Automated HPLC Analyzer, which is certified by the National Glycohemoglobin Standardization Program (NGSP) and is used as a reference method for establishing traceable results to the Diabetes Control and Complications Trial (DCCT). This represents a well-established, standardized reference measurement within the field of HbA1c testing.

8. The sample size for the training set:

This information is not provided. As an in vitro diagnostic assay (specifically an immunoassay), the development process typically involves reagent formulation, optimization, and extensive analytical validation. There isn't a "training set" in the sense of machine learning algorithms. The performance data presented are for the validated product.

9. How the ground truth for the training set was established:

This is not applicable as there is no explicit mention of a "training set" for an algorithm. The development of an immunoassay involves optimizing reagents and protocols to achieve desired performance, which is then validated against reference methods like the Tosoh G7. Any "ground truth" used during development would similarly refer to reference values from established methods or certified materials.

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