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The Bio-Rad VARIANT™ II TURBO HbA1c Kit - 2.0 is intended for the quantitative determination of hemoglobin A1c in human whole blood using ion-exchange high performance liquid chromatography (HPLC) on the VARIANT™ II TURBO Hemoglobin Testing System. Measurement of hemoglobin A1c is effective in monitoring long term glycemic control in individuals with diabetes mellitus. The Bio-Rad VARIANT™ II TURBO HbA1c Kit-2.0 is intended for Professional Use Only.

Device Description

The VARIANT II TURBO Hemoglobin Testing System uses the principles of high performance liquid chromatography (HPLC). The VARIANT II TURBO HbA12 Kit - 2.0 is based on chromatographic separation of Hemoglobin A10 on a cation exchange cartridge. The VARIANT II TURBO HbA1c Kit - 2.0 contains an analytical cartridge, 5 prefilters, Elution Buffer A and B, Calibrator Level 1, Calibrator Level 2, Whole Blood Primer, sample vials and a CD-ROM with test parameters.

The VARIANT II TURBO Hemoglobin Testing System provides an integrated method for sample preparation, separation and the quantitative determination of HbAle in EDTA human whole blood. The VARIANT II TURBO Hemoglobin Testing System is a fully automated, high-throughput hemoglobin analyzer. It consists of two modules - the VARIANT II Chromatographic Station (VCS) and the VARIANT II Sampling Station (VSS). There have been hardware updates due to obsolescence of parts and firmware updates to support the replacement hardware components.

A personal computer is used to control the VARIANT II TURBO Hemoglobin Testing System using updated Clinical Data Management (CDM) software version 5.1.1.

AI/ML Overview

Here's an analysis of the provided 510(k) summary, structured to answer your questions about acceptance criteria and the supporting study:

Some of the requested information, such as the specific country of origin for the data, the exact qualifications of experts, and the adjudication method for the test set, are not explicitly detailed in the provided 510(k) summary. This is typical for such regulatory documents, which focus on summarizing key performance data rather than granular study design details.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the "Method Comparison" study were based on a relative bias not exceeding +/- 10% at the decision points of 6% and 9% HbA1c.

Criteria	Acceptance Criteria (Bias)	Reported Device Performance (Predicted Bias by regression)	Upper 95% confidence limit	Lower 95% confidence limit
Decision point: 6.0 %HbA1c	Between -10% and +10% relative bias	0.2%	0.5%	-0.1%
Decision point: 9.0 %HbA1c	Between -10% and +10% relative bias	-0.1%	0.1%	-0.3%

The "Analytical Specificity" study aimed to show no significant interference from common hemoglobin variants at specified concentrations.

Interference Type	Acceptance Criteria	Reported Device Performance
Hemoglobin variants (HbS, HbC, HbD, HbE)	No significant interference (implicitly, results within pre-defined clinical limits or not exceeding a certain difference from non-variant samples). The predicate had issues with specific variants showing > ±10% difference.	No significant interference was observed at the following concentrations: HbS ≤67%, HbC ≤72%, HbD ≤55%, and HbE ≤41%.
Interference from HbA2	No interference from β-thalassemia trait HbA2 concentrations up to 10% of total hemoglobin.	β-thalassemia trait, as indicated by increased HbA2 concentrations up to 10%, does not interfere with the assay.

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

Sample Size (Method Comparison): 100 EDTA whole blood human samples and 16 samples prepared by mixing EDTA whole blood samples with either purified HbAo or purified HbA1c. Total: 116 samples.
Sample Size (Analytical Specificity): Not explicitly stated as a number of individual samples, but described as "Two fresh, EDTA non-variant human blood sample pools at 6.5% and 8.0-9.0% HbA1c" and "Fresh, EDTA human homozygous blood samples for each of the 4 hemoglobin variants (e.g. E, D, S, and C)." Series of test sample pools prepared by dilution.
Data Provenance: The data used for method comparison and analytical specificity were "EDTA whole blood human samples" and "fresh, EDTA human homozygous blood samples." The country of origin is not specified but is implicitly from a clinical laboratory setting. The studies appear to be prospective or concurrent as they involved preparing and running samples specifically for the study.

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

This information is not provided in the summary. The ground truth for the method comparison study was established by the predicate device's software version 4.03. For the analytical specificity, the "true" HbA1c values for the variant samples were likely determined by a reference method or assumed based on the preparation of the samples (e.g., dilution of homozygous variant samples).

4. Adjudication Method for the Test Set

This information is not provided in the summary. For a quantitative assay like HbA1c, adjudication typically involves comparing the device's results against a gold standard or a highly accurate reference method. In the method comparison, the predicate device's results served as the reference for the modified software.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable here. This document describes a medical device, the Bio-Rad VARIANT™ II TURBO HbA1c Kit - 2.0, which is an automated in vitro diagnostic (IVD) assay to measure HbA1c. It is not an AI-based diagnostic tool that assists human readers/interpreters.

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

The device itself is a standalone automated system for quantitative determination of HbA1c. The evaluation performed (method comparison and analytical specificity) effectively represents its standalone performance because it directly measures HbA1c levels without human interpretation of complex images or signals requiring AI assistance. The study compares the performance of the updated software/system to a previous version, which is a standalone comparison.

7. The Type of Ground Truth Used

Method Comparison: The ground truth for the method comparison study was established by the predicate device's software version 4.03 (meaning the measurements obtained from the same system running the older software). This is a "comparative ground truth" when assessing software changes.
Analytical Specificity: For variant interference, the ground truth was effectively implicit in the preparation of the samples (known variant concentrations, and expected HbA1c values in the pools). The goal was to show that the presence of these variants does not interfere with the HbA1c measurement, meaning the device's reading should remain accurate despite the variant's presence.

8. The Sample Size for the Training Set

This information is not provided in the summary. This device is an in vitro diagnostic (IVD) kit using high-performance liquid chromatography (HPLC) and associated software. While software might undergo internal development and validation (which could involve "training" in a broad sense, especially for algorithms identifying peaks), the concept of a "training set" as it applies to machine learning or AI models is not directly relevant or typically disclosed for this type of IVD device in a 510(k) summary. The summary focuses on comparing the new software's performance against the old, representing an update to an established analytical method.

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

As noted above, a "training set" in the context of AI/ML is not directly applicable. If one considers the development of the analytical method and software, the ground truth for establishing parameters would have been derived from extensive analytical chemistry principles and experiments, likely involving reference methods and characterized samples to ensure accurate chromatographic separation and calculation of HbA1c. This foundational work would be part of the product's overall development, not explicitly detailed as a "training set" in this 510(k) summary.

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