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The Bio-Rad VARIANT™ II TURBO Hemoglobin Alc Program is intended for the percent determination of hemoglobin A1c in human whole blood using ion-exchange high performance liquid chromatography (HPLC).

The VARIANT II TURBO Hemoglobin A1c Program is intended for Professional Use Only. For In Vitro Diagnostic Use.

Measurement of percent hemoglobin A1c is effective in monitoring long-term glucose control in individuals with diabetes mellitus.

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

The new feature in this submission is the upgrade in CDM software. The current software (CDM 3.6T) requires Windows NT. This product is nearing the end of its lifecycle. CDM 4.0 software is needed to transfer the CDM software to Microsoft XP Operating System.

The provided text describes the acceptance criteria and the study conducted to demonstrate the substantial equivalence of the VARIANT™ II TURBO Hemoglobin A1c Program with CDM 4.0 software to its predicate device (VARIANT II TURBO Hemoglobin A1c Program with CDM 3.6T).

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical targets that the device needed to meet independently for clinical accuracy. Instead, the study's goal was to demonstrate that the new device's performance was substantially equivalent to the predicate device. Therefore, the "reported device performance" is a comparison to the predicate device.

2. Sample Sizes and Data Provenance

• Accuracy (Test Set):
  • Sample size: 40 EDTA whole blood samples.
  • Data provenance: Not specified (e.g., country of origin). The samples were described as "whole blood samples," suggesting they were human clinical samples. It's retrospective in the sense that these samples likely existed prior to the test for the software upgrade.
• Precision (Test Set):
  • Sample size:
    • New device (CDM 4.0): 40 for Normal Sample, 40 for Diabetic Sample. (Note: These refer to the 'n' in the precision table, likely representing the number of data points or runs contributing to the precision calculation, not unique individuals).
    • Predicate device (CDM 3.6T): 80 for Normal Sample, 80 for Diabetic Sample.
  • Data Provenance: Not specified (e.g., country of origin). Human EDTA whole blood patient samples were used. The samples for the new device and predicate were run at "different time periods," implying they may not be the exact same set of physical samples, but rather samples representative of similar clinical conditions. This suggests a retrospective analysis of previously run precision studies for the predicate, and a new prospective study for the updated device, using similar protocols.

3. Number of Experts and Qualifications for Ground Truth

• Not Applicable. This is an in-vitro diagnostic (IVD) device, specifically a lab instrument measuring a biochemical marker (HbA1c). The ground truth is established by the analytical method itself (HPLC), not by expert interpretation of images or clinical data. The "ground truth" for comparison is the measurement obtained by the predicate device.

4. Adjudication Method for the Test Set

• Not Applicable. As mentioned above, this is an IVD device for quantitative measurement. There is no human interpretation or adjudication involved in determining the "ground truth" or the device's output. The comparison is objective, based on analytical results.

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

• Not Applicable. This device is an automated laboratory instrument. There are no human readers involved in the primary function (measuring HbA1c), so no MRMC study was performed or is relevant.

6. Standalone (Algorithm Only) Performance Study

• Yes, in essence. The study assessed the performance of the "VARIANT™ II TURBO Hemoglobin A1c Program run on the VARIANT II TURBO Hemoglobin Testing System using CDM 4.0" as a standalone system by comparing its results to results from the predicate system. The core software (CDM 4.0) is the "algorithm" here, and its performance is evaluated in direct comparison to the previous software version (CDM 3.6T) on essentially the same hardware.

7. Type of Ground Truth Used

• The ground truth used for comparison was the analytical measurement obtained from the predicate device (VARIANT II TURBO Hemoglobin A1c Program with CDM 3.6T). For the accuracy study, the individual sample results from the new device were compared against individual sample results from the predicate. For precision, the statistical measures (Mean, %CV) of replicate measurements were compared between the new device and the predicate.

8. Sample Size for the Training Set

• Not specified / Not applicable in the traditional sense of AI training. This submission describes a software upgrade for an existing analytical instrument, primarily focusing on migrating the operating system and making minor adjustments to data management. There is no mention of a machine learning or AI algorithm being trained on a specific dataset. The "development" of the CDM 4.0 software likely involved traditional software engineering and testing, not a data-driven training process in the way AI models are trained.

9. How Ground Truth for the Training Set Was Established

• Not applicable. As noted above, there's no indication of a machine learning or AI training set as part of this submission. The "ground truth" for software functionality and performance would have been established through standard software development and verification/validation processes against predefined specifications for the new operating system and database changes.

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