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CRP reagent, with associated calibrators and controls, are intended for use on ABX PENIRA 400 ClinicaLChemistry Analyzer to measure C-reactive Protein analyte.

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

The ABX PENTRA Low CRP Control is for use in quality control by monitoring accuracy and precision for the quantitative ABX PENTRA CRP CP method.

ABX PENTRA CRP CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of the C-reactive protein in human serum and plasma based on an immunoturbidimetric assay.

The ABX PENTRA Immuno I Control L/H is for use in quality control by monitoring accuracy and precision for CRP.

Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissue.

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 CRP CP is an in vitro diagnostic assay for the quantitative determination of C-reactive protein in human serum and plasma based on an immunoturbidimetric test. The assay is composed of a bi-reagent cassette, with 25 ml and 23.5 ml compartments. Reagents are chemical solutions with additives.

The ABX PENTRA CRP Cal is a liquid human serum calibrator with chemical additives. It has 5 levels to be used for the calibration of the crp assay. The assigned values are given on the calibrator vials. This calibrator is provided in five vials of 1 ml.

The ABX PENTRA Immuno I Control L/H is a lyophilized two-level quality control product consisting of human serum. The assigned values of the control components are given in the enclosed annex, ensuring control of the appropriate HORIBA ABX methods on the ABX PENTRA 400 analyzer. Each level of control is provided in one vials of 3 ml.

The ABX PENTRA Low CRP Control is a liquid assayed control prepared by diluting crp at low concentration in human serum. It has to be used for the quality control of low levels measured with the crp assay. The assigned value is given in the enclosed annex. This control is provided in four vials of 1 ml.

The ABX PENTRA Clean-Chem CP and ABX PENTRA Clean-Chem 99 CP are ready-to-use chemical cleaning solutions for use on the ABX Pentra 400 system. They are respectively provided in mono-reagent 30 ml and 4 x 99 ml cassettes.

The provided document describes the Horiba ABX PENTRA CRP CP reagent and associated calibrators, controls, and cleaning solutions for use on the ABX PENTRA 400 clinical chemistry analyzer. The study detailed is aimed at demonstrating substantial equivalence to predicate devices for these in vitro diagnostic products.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" as a distinct set of pre-defined thresholds. Instead, it presents "Performance Data" for the reagents, which are implicitly considered in evaluating substantial equivalence. For the purpose of this response, I will interpret the 'Performance Data' section for the ABX PENTRA CRP CP reagent as the established performance and thus the implicit criteria met by the device.

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

• Sample Size for the Test Set: For the "Correlation" study, a sample size of n=190 was used.
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given the submitter (Horiba ABX) is located in France, it's plausible the studies were conducted in France or Europe, but this is not confirmed. The nature of the studies (e.g., "Performance Data" for accuracy, precision, stability) suggests these are likely prospective studies conducted during the device development and validation.

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

This type of information is generally not applicable to in vitro diagnostic (IVD) devices like the CRP assay described. The "ground truth" for chemical assays like CRP is typically established by comparing the device's results to a predicate device or a well-established reference method, not by expert consensus in the same way it would be for imaging diagnostics. The document doesn't mention any experts for establishing ground truth, as it relies on analytical performance metrics.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies, often involving human readers interpreting data where there might be subjective differences. For analytical performance of an IVD like a CRP assay, measurements are quantitative, and the "ground truth" is derived from the reference method, not through consensus or adjudication amongst human observers.

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

Not applicable. The device described is an in vitro diagnostic reagent and system for measuring C-reactive protein. It is not an AI-assisted diagnostic tool or an imaging device that involves human readers interpreting cases. Therefore, an MRMC comparative effectiveness study is not relevant to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. The device is a chemical reagent and an automated analyzer, not an algorithm. Its performance is inherent to the chemical reaction and the analytical instrument, which operates without "human-in-the-loop" interpretation for the actual CRP measurement (though a human operator initiates tests and reviews results). The "standalone" performance here refers to the analytical performance of the system itself.

7. The Type of Ground Truth Used

The ground truth for the ABX PENTRA CRP CP assay is established through correlation with a predicate device or a well-established reference method. The correlation data (Y = 1.03 x - 0.18 with r² = 0.997) suggests a comparison against another method (likely the predicate device K023828). This is a form of analytical ground truth, where the accuracy of the new device is verified against a method known to provide accurate measurements.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning or AI. For in vitro diagnostic assays, the development process involves extensive internal testing and optimization of reagent formulations, calibration curves, and instrument parameters, which could be considered analogous to "training" data. However, the exact sample sizes for such internal optimization are not provided, nor is this typically reported in a 510(k) summary for this type of device. The reported sample size of 190 (for correlation) is for the performance validation/test set.

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

As "training set" is not explicitly defined or discussed in the context of this IVD, the method for establishing its ground truth is not provided. Assuming "ground truth" for an IVD refers to accurate concentration values, these would typically be established using traceable reference materials or highly accurate reference methods during the development and optimization phases.

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