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ARKIT HbA1c is a laboratory test intended for the quantitative determination of hemoglobin A1c % in blood by an enzymatic method, to monitor long-term blood glucose control in individuals with diabetes mellitus.

The ARKIT HbA1c Calibrator and ARKIT HbA1c Control are designed to be used with the ARKIT HbA1c test for the determination of HbA1c in blood.

For in vitro diagnostic use only.

The ARKIT HbA1c kit is a laboratory test kit, intended for quantitative determination of hemoglobin A1C % in blood by an enzymatic method, to monitor long-term glucose control in individuals with diabetes mellitus.

The ARKIT HbA1c kit is comprised of a Reagent 1, Reagent 2, Reagent 3 and an Hb Reagent (all of these components/materials are provided within the ARKIT HbA1c kit). It also offers an optional ARKIT HbA1C Calibrator (2 level; low and high) intended to be used as an exclusive calibrator of ARKIT HbA1c test as well as an optional ARKIT HbA1c Control, also 2 level; low and high, recommended as a control for the ARKIT test kit. The optional Calibrator and Control materials are required, but not provided within the ARKIT HbA1c kit.

Measurement of hemoglobin A1c % can be determined from the use of red blood cells or whole blood. The measurement principle of hemoglobin concentration is alkaline hematin method that is a general measurement method using Hb Reagent. However, Hb Reagent may not be used by the performance of chemistry analyzer. In this case, hemoglobin is measured simultaneously with hemoglobin A1c by using Reagent 2 and this measurement principle is the oxyhemoglobin method that is a general measurement method.

Hemoglobin A1c in a hemolysate sample is digested proteolysis for glycated hemoglobin sites by specific protease and the product is measured by fructosyl amino acid oxidase (FAOD), peroxidase (POD) and coupler.

Erythrocytes are hemolyzed to prepare a sample. Hemoglobin is contained in the hemolyzed sample and is digested with protease and fructosyl amino acid for generates. Fructosyl amino acid oxidase acts on this fructosyl amino acid and generates hydrogen peroxide. The concentration of this hydrogen peroxide is in direct proportion to that of hemoglobin A 1c in blood. Adding POD to this sample develops color by catalysis of POD. The concentration of hydrogen peroxide can be determined by measuring the concentration of the pigment. As a result, the concentration of hemoglobin A1c in blood can be determined.

The provided text describes the ARKIT HbA1C device, its intended use, and a study comparing its performance to a predicate device. However, it does not explicitly state "acceptance criteria" in a tabulated format as often seen in regulatory submissions with specific numerical thresholds for performance metrics.

Instead, the document highlights the device's performance through:

• Accuracy and Precision: Stating "ARKIT HbA1C assays demonstrate excellent accuracy and precision results."
• Method Comparison: Indicating "ARKRAY HbA1c assays yielded very close correlations in all samples, across the intended, usable range of the device" when compared to the predicate device.

Below is an attempt to structure the information based on the provided text, acknowledging that specific "acceptance criteria" values are not explicitly stated. The study proves the device meets these unstated criteria by demonstrating "excellent accuracy and precision" and "very close correlations" with the predicate.

Acceptance Criteria and Device Performance

Since explicit numerical acceptance criteria are not provided, the table below interprets the study's conclusions as the implicit acceptance criteria that the device met.

• Studied three levels of samples for accuracy.
• Within-run accuracy: Each sample studied twenty times within one batch; mean, standard deviation (SD), and coefficient of variation (CV) calculated.
• Between-run and between-days accuracy: Studied per NCCLS Guidelines (EP05-A); mean, SD, and CV calculated. |
  | Precision: Demonstrate excellent precision. | "ARKIT HbA1C assays demonstrate excellent ... precision results."
• Studied three levels of samples for precision.
• Within-run precision: Each sample studied twenty times within one batch; mean, SD, and CV calculated.
• Between-run and between-days precision: Studied per NCCLS Guidelines (EP05-A); mean, SD, and CV calculated. |
  | Method Comparison/Correlation: Yield very close correlations with the predicate device (Roche UNIMATE HBA1C) across the intended, usable range. | "the ARKRAY HbA1c assays yielded very close correlations in all samples, across the intended, usable range of the device."
• Compared to Roche UNIMATE HBA1C.
• In independent measurement studies of hemoglobin and simultaneous measurement of hemoglobin, and comparison with the predicate device in both independent and simultaneous measurements. |
  | Equivalence of Hemoglobin Measurement Methods: Performance of simultaneous hemoglobin measurements with HbA1c is equivalent to independent Hb measurement using the Hb reagent. | Performance is equal based upon the results of "Evaluation of Precision," "Method comparison and Correlation," "Linearity," and "Correlation of measurement of hemoglobin." (This suggests that the equivalence itself was an implicit acceptance criterion met by these specific performance metrics.) |

Study Details

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

   • Sample Size: 98 diabetic patient samples were used for the method comparison study.
   • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). It mentions "diabetic patient samples," implying human samples.

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

   • Not applicable. This is an In Vitro Diagnostic (IVD) device for quantitative determination of a biomarker, not image interpretation by experts. Ground truth is established by the reference method or predicate device performance.

3. Adjudication method for the test set:

   • Not applicable. This is an IVD device comparison study, not an expert-adjudicated diagnostic study.

4. 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 IVD device for laboratory determination, not an AI-assisted diagnostic imaging device with human readers.

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

   • Yes, the performance study describes the standalone performance of the ARKIT HbA1c assay. The entire study evaluated the device's output (quantitative determination of HbA1c) directly.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" or reference for comparison was the Roche UNIMATE HBA1C device (predicate device). Additionally, the device's own performance metrics (accuracy, precision, linearity) were evaluated against established analytical chemistry principles (e.g., NCCLS Guidelines).

7. The sample size for the training set:

   • Not applicable for this type of IVD device. The description does not mention a training set in the context of machine learning or AI. IVD devices are typically developed based on chemical/enzymatic principles and analytical validation, not statistical models trained on data in the traditional AI sense.

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

   • Not applicable, as no training set (in the AI/ML context) is mentioned.

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