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The Bio-Rad D-10 Hemoglobin A1c Program is intended for the percent determination of hemoglobin A1c in human whole blood using ion-exchange high performance liquid chromatography (HPLC). The D-10 Hemoglobin A1c Program is intended for use only with the Bio-Rad D-10 Hemoglobin Testing System. For In Vitro Diagnostic Use.

The D-10 Hemoglobin Testing System uses the principles of high performance liquid chromatography (HPLC). The D-10 Hemoglobin A1c Program is based on chromatographic separation of Hemoglobin A1c on a cation exchange cartridge.

This document describes the Bio-Rad D-10™ Hemoglobin A1c Program, a device intended for the percent determination of hemoglobin A1c in human whole blood. The submission focuses on establishing substantial equivalence to a predicate device, the VARIANT™ II Hemoglobin A1c Program.

1. Table of Acceptance Criteria and the Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a quantitative manner as typically seen for novel devices. Instead, it aims to demonstrate substantial equivalence to a predicate device through method correlation. Therefore, the "acceptance criteria" can be inferred as achieving excellent correlation with the predicate device.

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

• Sample Size: 40 anticoagulated whole blood samples.
• Data Provenance: Not explicitly stated but clinical samples of human whole blood. The document doesn't specify the country of origin or if it's retrospective or prospective. Given the nature of a 510(k) submission for an in vitro diagnostic device, these samples would likely be collected specifically for the study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This is an analytical performance study comparing two similar devices for measuring HbA1c, not a study involving expert interpretation of images or clinical outcomes. The "ground truth" for the test set samples is the measurement provided by the predicate device (VARIANT II Hemoglobin A1c Program).

4. Adjudication method for the test set:

Not applicable. This study compares quantitative measurements, not subjective assessments requiring adjudication.

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 an analytical performance study of an in vitro diagnostic device, not an AI-assisted diagnostic imaging study involving human readers.

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

Yes, this is a standalone performance assessment of the D-10 Hemoglobin A1c Program against the predicate device. The device reports a quantitative value (percent HbA1c) directly.

7. The type of ground truth used:

The "ground truth" for this study is the measurement obtained from the predicate device, the VARIANT™ II Hemoglobin A1c Program. Both devices are standardized to the Diabetes Control and Complications Trial (DCCT) reference method and IFCC, and certified via the National Glycohemoglobin Standardization Program (NGSP).

8. The sample size for the training set:

Not applicable. This device is a pre-programmed ivD based on established HPLC principles, not a machine learning or AI model that requires a training set in the typical sense. Its "training" is inherent in its design and calibration processes, which are themselves subject to standardization (DCCT, IFCC, NGSP).

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

Not applicable. As above, this is an analytical instrument, not an AI/ML model with a distinct training set and ground truth establishment methodology. The device's accuracy relies on its adherence to established analytical principles and standardization protocols (DCCT, IFCC, NGSP).

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