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The UniCel DxC Synchron Systems Hemoglobin A1c3 (HbA1c3) Reagent, when used in conjunction with UniCel DxC 600/800 SYNCHRON Systems, UniCel DxC SYNCHRON Systems HbA1c3 Calibrators and HbDIL reagent, is intended for the quantitative determination of hemoglobin A1c concentration in human whole blood.

The A1c3 and Hb3 values generated as part of the HbA1c3 assay are intended for use in the calculation of the A1c3/Hb3 ratio and must not be used individually.

Measurement of hemoglobin A1c measures long-term glycemic control in patients with diabetes mellitus.

The UniCel DxC SYNCHRON Systems Hemoglobin A1c3 (HbA1c3) Reagent is intended for the quantitative determination of hemoglobin A1c concentration in human whole blood. The UniCel DxC Systems utilize two unique cartridges, Hb3 and A1c3, to determine hemoglobin A1c concentration as a ratio of total hemoglobin.

Hb3 reagent is used to measure total hemoglobin concentration by a colorimetric method. The system automatically proportions the appropriate sample and reagent volumes into the cuvette. The ratio used is one part sample to 8,6 parts reagent. The system monitors the change in absorbance at 410 nanometers. This change in absorbance is directly proportional to the concentration of total hemoglobin in the sample and is used by the system to calculate and express total hemoglobin concentration.

A1c3 reagent is used to measure the hemoglobin A1c concentration by a turbidimetric immunoinhibition method. In the reaction. hemoglobin A1c antibodies combine with hemoglobin A1c from the sample to form soluble antigen-antibody complexes. Polyhaptens from the reagent then bind with the excess antibodies and the resulting agglutinated complex is measured turbidimetrically. The system automatically proportions the appropriate sample and reagent volumes into the cuvette. The ratio used is one part sample to 28 parts reagent. The system monitors the change in absorbance at 340 nanometers. This change in absorbance is inversely proportional to the concentration of hemoglobin A1c in the sample and is used by the systems to calculate and express hemoglobin A1c concentration as a ratio of total hemoglobin.

Here's an analysis of the acceptance criteria and study detailed in the provided 510(k) summary for the UniCel DxC SYNCHRON Systems Hemoglobin A1c3 (HbA1c3) Reagent:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria and Device Performance for Analytical Studies

Precision Data (EP5-A2 and Additional Within-run)

The document primarily reports SD and %CV for various sample types and instruments, derived from experiments following CLSI EP5-A2 guidelines. No explicit "acceptance criteria" (e.g., maximum allowable %CV) are stated for these precision values within the provided text, but the data is presented as a summary of performance. The precision results demonstrate low variability across controls and human whole blood samples for both DxC 600 and DxC 800 instruments, indicating good analytical precision.

2. Sample Sizes and Data Provenance

• Method Comparison:
  • DxC 600: N = 119 samples
  • DxC 800: N = 118 samples
  • Data Provenance: Not explicitly stated, but the context of an FDA submission for a diagnostic kit suggests these would be human blood samples from a clinical laboratory setting. It is not specified if they are retrospective or prospective.
• Anticoagulant Study: The N-value for these studies is not explicitly stated in the summary, but given the Deming Regression analyses, it would involve a sufficient number of samples across the range to establish the stated regressions.
• CLSI EP5-A2 Precision Study:
  • DxC 600: 80 data points for each of 5 sample types (2 controls, 3 human whole blood samples) = 400 data points total.
  • DxC 800: 80 data points for each of 5 sample types (2 controls, 3 human whole blood samples) = 400 data points total.
  • Data Provenance: "Whole Blood Control" and "Human Whole Blood Sample" indicates human samples. Not specified if retrospective or prospective or country of origin.
• Additional Within-run Precision Study:
  • DxC 800: 20 data points for one human whole blood sample (@14% HbA1c).
  • DxC 600: 20 data points for one human whole blood sample (@14% HbA1c).
• Interference Study: "Whole blood samples spiked with..." various substances. N-values for these individual spiked samples are not specified, but the study was conducted across three HbA1c levels (5%, 7%, & 10% NGSP).
• Linearity Study: N-values for linearity curves are not explicitly stated, but the strong R-values (R > 0.99) indicate a sufficient number of data points were used across the analytical range to establish robust linearity.
• Specificity Study: N-values for samples with HbS, HbC, HbF, etc., are not specified.

3. Number of Experts and Qualifications for Ground Truth

• No human "experts" are referenced for establishing ground truth in this context. The UniCel DxC SYNCHRON Systems Hemoglobin A1c3 (HbA1c3) Reagent is an in vitro diagnostic (IVD) device that quantitatively measures a biomarker (HbA1c).
• For IVD devices, the "ground truth" and comparison methods are typically other established laboratory methods or reference methods. The predicate device (UniCel DxC SYNCHRON Systems Hemoglobin A1c- Reagent, K121492) serves as the primary "ground truth" for method comparison, which itself would have been validated against a gold standard.
• The calibrator traceability is reported as the IFCC HbA1c reference method, which is a globally recognized, highly accurate, and standardized method for HbA1c measurement, effectively serving as the ultimate "ground truth" for calibration and accuracy.

4. Adjudication Method

• Not applicable for this type of IVD device study. Adjudication methods (like 2+1, 3+1) are typically used in imaging studies or clinical trials where human interpretation or consensus is required to establish a ground truth or resolve discrepancies in observations. This submission is for an analytical instrument's performance.

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

• No, an MRMC comparative effectiveness study was not done. This type of study (comparing human readers with and without AI assistance) is relevant for AI/ML-driven diagnostic aids that assist human interpretation, particularly in radiology or pathology. This device is an automated in vitro diagnostic reagent system, not an AI-assisted interpretation tool.

6. Standalone (Algorithm Only) Performance Study

• Yes, this entire submission is a standalone performance study (algorithm only, in the context of an automated analytical instrument). The device (UniCel DxC SYNCHRON Systems HbA1c3 Reagent) on the DxC 600/800 SYNCHRON Systems operates as a quantitative analytical instrument, without human-in-the-loop interpretation impacting the result generation. The performance metrics (method comparison, precision, linearity, interference) directly assess the analytical output of the system.

7. Type of Ground Truth Used

• The ground truth used for validation is primarily comparison to the predicate device (UniCel DxC SYNCHRON Systems Hemoglobin A1c- Reagent, K121492), which itself is established against the IFCC HbA1c reference method (mentioned for calibrator traceability). For linearity and precision studies, the intrinsic property of the samples (e.g., known concentrations for linearity, reproducibility for precision) serves as the ground truth.

8. Sample Size for the Training Set

• Not applicable. This device is an in vitro diagnostic device based on established chemical and immunochemical reactions. It is not an AI/ML device that requires a "training set" in the machine learning sense. The device is developed and optimized through traditional analytical chemistry and immunochemistry principles. Therefore, there is no "training set" as understood in AI/ML.

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

• Not applicable. As there is no "training set" for an AI/ML algorithm, the concept of establishing ground truth for it does not apply here. The analytical performance of the new reagent system is compared against the predicate device and established analytical methods.

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