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ABX PENTRA HBAIc WB reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of Hemoglobin A1c percentage (%HbAlc) in human whole blood based on a colorimetric and turbidimetric assay. It is intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer

Percent HbA1c measurements are used in the clinical management of diabetes to assess the long-term efficacy of diabetic control.

The ABX PENTRA HbAIc WB Cal is a calibrator for use in the calibration of quantitative Horiba ABX PENTRA HbAIc WB method on Horiba ABX clinical chemistry analyzers.

The ABX PENTRA HbAlc WB Control is for use in quality control by monitoring accuracy and precision for the quantitative ABX PENTRA HbA1c WB method.

The ABX PENTRA HbA1c WB Hemolysis Reagent is an additional reagent for use in combination for the quantitative ABX PENTRA HbA1c WB method.

All the reagents, controls and calibrators included in this submission are for use on the ABX PENTRA 400 (K052007), which is a discrete photometric benchtop clinical chemistry analyzer.

The ABX PENTRA HbA1c WB is an in vitro diagnostic assay for the quantitative determination of Hemoglobin A1c in human whole blood based on a turbidimetric and colorimetric test. The assay is composed of the following vials:

• 1 x 23 ml vial (R1) 1 x 23 ml vial (R2) 1 x 110 ml vial (R3) 2 x 21 ml vials (R4) 1 x 25 ml vial (R5)

Reagent R1 is prepared from substances of animal origin and purified with human material. Reagents R2 and R3 are prepared from substances of animal origin and chemical solutions. R4 and R5 are chemical solutions with additives.

The ABX PENTRA HbA1c Cal is a liquid multi-calibrator prepared from chemical solutions. It is used for the calibration of the HbA1c assays. The assigned values are given in the notice. This calibrator has six levels and is provided in one vial of 8 ml and five vials of 2 ml.

The ABX PENTRA HbA1c Control is a lyophilized assayed control prepared from human whole blood. It has 2 levels (Normal and Pathological) to be used for the quality control of HbA 1c assays. The assigned values are given in the enclosed annex. Each level of this calibrator is provided in two vials of 0.25 ml. The kit contains also a 2 ml reconstitution buffer vial.

The ABX PENTRA HbA1c WB Hemolysis Reagent is a chemical solution for use in the lysis of red blood cells with the HbA1c HORIBA ABX methods on the ABX Pentra 400 system. It is provided in a 110 ml vial.

Here's a breakdown of the acceptance criteria and study information for the ABX PENTRA HbA1c WB device, based on the provided 510(k) summary:

Acceptance Criteria and Reported Device Performance

The document states that the "performance testing data conclude that the safety and effectiveness of the devices are not compromised, and that they met all acceptance criteria, demonstrating that the devices are substantially equivalent to their respective predicate devices." This implies that the reported performance values across these metrics met the predefined acceptance criteria.

Study Information

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

   • Sample Size: 144 samples were used for the correlation studies (Accuracy). The document does not explicitly state the sample sizes for other performance characteristics like precision or linearity, but it can be inferred that samples were also used for these tests.
   • Data Provenance: Not explicitly stated. The document is a 510(k) summary from Horiba ABX, a company based in France. It doesn't specify if the clinical samples were collected in France, the US, or elsewhere, nor does it explicitly state if the data was retrospective or prospective.

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

   • This information is not provided in the summary. For an in vitro diagnostic (IVD) device like this, the "ground truth" for a calibrator or control would typically be established through highly accurate reference methods or by comparison to certified reference materials. For patient samples, the reference method used for comparison (e.g., HPLC, another cleared HbA1c assay) would serve as the ground truth. The summary refers to the predicate device for substantial equivalence, implying the comparison was against a previously cleared method.

3. Adjudication method for the test set:

   • This information is not applicable to this type of device and study. Adjudication methods like 2+1 or 3+1 are typically used in imaging studies where human interpretation of results is involved and discrepancies need to be resolved. For an IVD assay, the comparison is typically against a reference measurement, not subjective expert assessment.

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:

   • No, an MRMC comparative effectiveness study was not done. This type of study is relevant for imaging or diagnostic aids where human readers interpret results, often with and without AI assistance. The ABX PENTRA HbA1c WB is an automated in vitro diagnostic assay, not an AI-assisted interpretation tool for human readers.

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

   • Yes, the performance data presented (accuracy, precision, linearity, measuring range, stability) are for the standalone algorithm/device performance. This device operates as an automated clinical chemistry analyzer, and its performance characteristics are intrinsic to the device itself without direct human interaction varying the outcome beyond sample preparation and loading.

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

   • For the accuracy/correlation study, the ground truth would have been established by comparison to a reference method or predicate device. The summary states the device demonstrated "substantial equivalence" to predicate devices (K031380 (Olympus) and K955087 (Bayer)). This implies the correlation studies were performed by comparing results from the ABX PENTRA HbA1c WB against results obtained from these established, legally marketed HbA1c assays, which are themselves considered reliable "ground truth" for clinical use.

7. The sample size for the training set:

   • This information is not applicable and not provided. This device is a reagent and associated components for an existing clinical chemistry analyzer (ABX PENTRA 400). It's an in vitro diagnostic assay, not a machine learning or AI-driven algorithm that requires a "training set" in the conventional sense of AI development. The development of such assays involves chemical and biochemical optimization, not an algorithmic training phase with a labeled dataset.

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

   • This information is not applicable, as there is no "training set" in the context of an AI/machine learning algorithm for this device. The development and validation of the reagents, calibrators, and controls would involve rigorous analytical methods to ensure their chemical and functional properties meet specifications.

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