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The ABX PENTRA Urine Cal is a calibrator for use in the calibration of the quantitative method : ABX PENTRA Urinary Proteins CP on Horiba ABX PENTRA 400 clinical chemistry analyzer.

The calibrator included in this submission is for use on the ABX PENTRA 400 (K052007), which is a discrete photometric benchtop clinical chemistry analyzer. The ABX PENTRA Urine Cal is a liquid calibrator based on a buffered aqueous solution, with chemical additives and materials of biological origin. The assigned values of the calibrator components are given in the enclosed annex, ensuring optimal calibration of the appropriate HORIBA ABX methods on the ABX PENTRA 400 analyzer. This calibrator is provided in three vials of 1 ml.

This document describes the premarket notification for the ABX PENTRA Urine Calibrator, a device intended for use on the ABX PENTRA 400 clinical chemistry analyzer to quantify total proteins in urine.

1. Acceptance Criteria and Reported Device Performance:

The document states that the performance testing data demonstrated that the device met all acceptance criteria, and its safety and effectiveness are not compromised. The specific, quantitative acceptance criteria are not explicitly detailed in the provided text, nor are specific performance metrics like accuracy, precision, or linearity values for the calibrator directly reported beyond the general statement of meeting criteria. The document primarily focuses on demonstrating substantial equivalence to a predicate device.

2. Sample Size for Test Set and Data Provenance:

The document does not specify the sample size used for the test set (performance testing) of the ABX PENTRA Urine Calibrator. It also does not mention the country of origin of the data or whether the study was retrospective or prospective.

3. Number and Qualifications of Experts for Ground Truth:

The document does not mention the use of experts to establish ground truth for the test set.

4. Adjudication Method:

The document does not mention any adjudication method for the test set. This is not typically relevant for a calibrator study.

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

A MRMC comparative effectiveness study was not performed or reported. This type of study is not applicable for a device like a calibrator, which is evaluated for its analytical performance rather than impact on human reader interpretation.

6. Standalone Performance (Algorithm Only):

The device is a calibrator, not an algorithm, so a standalone performance study in the context of an "algorithm only" is not applicable. The performance testing described relates to the analytical performance of the calibrator itself and its interaction with the analyzer and reagent.

7. Type of Ground Truth Used:

The document does not explicitly state the type of "ground truth" used for performance testing. For a calibrator, the ground truth would typically be established by reference methods or gravimetric/volumetric analysis to assign precise values to the calibrator components. The document mentions "assigned values of the calibrator components are given in the enclosed annex," implying that these assigned values serve as the reference for performance evaluation.

8. Sample Size for Training Set:

The concept of a "training set" is typically associated with machine learning algorithms. Since the ABX PENTRA Urine Cal is a calibrator and not an AI/ML device, a training set in that context is not applicable and therefore not reported.

9. How Ground Truth for Training Set Was Established:

As there is no training set mentioned or applicable for this device, the method for establishing its ground truth is not applicable.

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