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Hepatic Enzymes reagents, with associated calibrators and controls, are intended for Hopano Enlighted Chemistry Analyzer to measure a variety of analytes.

ABX PENTRA AST CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of aspartate aminotransferase in human serum and plasma based on a UV test using L-aspartate and 2-oxoglutarate. Aspartate aminotransferase measurements are used in the diagnosis and treatment of certain types of liver and heart diseases.

The ABX PENTRA Multical is a calibrator for use in the calibration of quantitative Horiba ABX methods on Horiba ABX clinical chemistry analyzers.

The ABX PENTRA N Control is for use in quality control by monitoring accuracy and precision.

The ABX PENTRA P Control is for use in quality control by monitoring accuracy and precision.

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 400 offers both Closed and Open channels for a multitude of parameters (clinical chemistry, DAT, TDM, plasma protein, hemostasis, optional ISE module).

All reagents described in this submission are for the quantitative in-vitro determination of their respective parameters

Here's a breakdown of the acceptance criteria and study information for the ABX PENTRA AST CP reagent, ABX PENTRA Multical, ABX PENTRA N Control, and ABX PENTRA P Control, as derived from the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Study Details:

The provided document describes a premarket notification (510(k)) submission, which primarily focuses on demonstrating substantial equivalence to a predicate device rather than conducting a full-scale clinical effectiveness study as might be seen for novel devices. The performance data presented are used to support this substantial equivalence claim.

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

• Sample Size for Correlation Study: n=103 (for the ABX PENTRA AST CP reagent).
• Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. Given the manufacturer (Horiba ABX Company) is based in France, it is likely that at least some, if not all, of the data originated from studies conducted in France or related European sites. For in vitro diagnostic devices, method validation studies are typically prospective.

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 document. For in vitro diagnostic assays like this, "ground truth" for method comparisons is typically established by comparing the candidate device's results against a well-established, often FDA-cleared or gold standard, reference method or predicate device, rather than expert consensus on individual cases. The correlation data (Y = 0.99 x + 1.25 with r² = 0.9963) refers to this type of comparison.

4. Adjudication Method for the Test Set

• This concept of "adjudication method" (like 2+1 or 3+1) is not applicable to this type of in vitro diagnostic device study. Adjudication usually refers to a process in diagnostic imaging or clinical trials where multiple human readers or clinicians evaluate cases and resolve discrepancies. For this blood test device, performance is evaluated through analytical methods (precision, accuracy, correlation to a reference method).

5. 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 medical imaging AI devices that assist human interpretation, not for an in vitro diagnostic chemistry analyzer and its associated reagents and controls. The device described here is for quantitative measurement of a biochemical marker, not for interpreting complex human data like radiology images.

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

• This device is essentially a standalone device in terms of its ability to perform the measurement. The ABX PENTRA 400 analyzer (the platform) and the ABX PENTRA AST CP reagent system measure AST levels, and this measurement is done by the automated system without direct human interpretation of the "result generation" process for each test. The human "in the loop" is the lab technician who loads samples, ensures quality control, and reviews the reported numerical results. The performance metrics provided (detection limit, accuracy, precision, measuring range, correlation, stability) all reflect the standalone analytical performance of the system.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

• The "ground truth" for the ABX PENTRA AST CP reagent and the associated controls/calibrators is implicitly established by comparison to a predicate device (K801118) and likely other well-established or reference analytical methods for AST measurement. The correlation study directly relates the device's measurements (Y) to those of a comparator (x), which serves as the "truth" or reference for the study's purpose of demonstrating substantial equivalence. For calibrators and controls, ground truth relates to their assigned values and their stability characteristics under various conditions.

8. The Sample Size for the Training Set

• This information is not applicable in the context of this 510(k) submission for an in vitro diagnostic reagent system. "Training set" refers to data used to train machine learning models. This device is a chemical reagent and an automated analyzer, not an AI/ML-based diagnostic tool. The development process would involve extensive analytical validation experiments, but not a "training set" in the AI sense.

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

• As stated above, the concept of a "training set" and associated "ground truth establishment" for it does not apply to this type of device. The ground truth for analytical performance, as discussed in point 7, is established through comparison with established reference methods or predicate devices.

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