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ABX PENTRA Urea CP reagent with associated calibrators and controls are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer for quantitative in vitro diagnostic determination of urea / urea nitrogen (an end-product of nitrogen metabolism) in human serum, plasma and urine based on an enzymatic UV test using urease and qlutamate dehydrogenase. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.

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

Device Description

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 Urea CP is an in vitro diagnostic assay for the quantitative determination of urea / urea nitrogen (an end-product of nitrogen metabolism) in human serum, plasma and urine based on an enzymatic UV test using urease and glutamate dehydrogenase. It is composed of a bi-reagent cassette, with 60 ml and 15 ml compartments. Reagents are chemical solutions with additives.

The ABX PENTRA Urine Control L/H is a two-level (Low and High) quality control consisting of liquid solutions prepared from human urine with chemical additives and materials of biological origin added as required to obtain given component levels. 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 control level is provided in one vial of 10 ml.

AI/ML Overview

The provided 510(k) summary describes the acceptance criteria and performance study for the ABX PENTRA Urea CP reagent (for urine samples) and ABX PENTRA Urine Control L/H.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Device: ABX PENTRA Urea CP (for urine samples)

Acceptance Criteria	Reported Device Performance
Detection Limit	Urea: 12.6 mmol/l
	BUN: 35 mg/dl
Accuracy and Precision	CV Total < 7.50%
Measuring Range	Urea: 12.6 - 750.0 mmol/l
	BUN: 35 - 2106 mg/dl
Upper Linearity Limit	Urea: 750 mmol/l (3750 mmol/l with automatic post-dilution)
	BUN: 35 mg/dl (2106 mg/dl with automatic post-dilution)
Correlation	Urea: $Y = 1.13 x - 0.71$ with $r^2 = 0.9947$
	BUN: $Y = 1.13 x - 2.08$ with $r^2 = 0.9947$
Calibration Stability	8 days
Reagent Stability	Closed: 24 months at 2-8°C
	On-board: 70 days

Device: ABX PENTRA Urine Control L/H

Acceptance Criteria	Reported Device Performance
Analytes Covered	Amylase, Calcium, Creatinine, Phosphorus, Urea / Blood Urea Nitrogen, Urinary proteins (some were already cleared, Urea/BUN is included in this submission).
Format	Liquid solution prepared from human urine with chemical additives and materials of biological origin.
Stability	Closed: 2 years at 2-8°C
	Open: 30 days at 2-8°C

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

Sample Size for Test Set:
- For the Correlation study of ABX PENTRA Urea CP (urine samples), n=147 samples were used.
- No specific sample size is explicitly stated for other performance metrics (Detection Limit, Accuracy, Precision, Measuring Range, Linearity, Stability) but these are typically tested with a sufficient number of replicates and samples to satisfy internal validation protocols.
Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective.

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

This information is not provided in the document. The studies described are for an in vitro diagnostic (IVD) reagent and control, where "ground truth" often refers to reference methods or comparative assays, not expert consensus in the same way it would for imaging diagnostics.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies involving interpretation by multiple human readers, not for analytical performance testing of biochemical assays.

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

This information is not applicable and not provided. MRMC studies are relevant for imaging devices or software that assist human interpretation. This submission is for an in vitro diagnostic reagent and control.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The performance data presented is for the reagent and control used on the ABX PENTRA 400 analyzer, which is an automated clinical chemistry analyzer. Therefore, the reported performance metrics (detection limit, accuracy, precision, measuring range, linearity, correlation, stability) represent the standalone performance of the device system (reagent + analyzer) without human interpretive input. The product is not an "algorithm" in the sense of AI/ML, but a chemical test system.

7. Type of Ground Truth Used

For the Correlation study of ABX PENTRA Urea CP, the reported correlation coefficients ($r^2$) and linear equations imply a comparison against a reference method or predicate device's results (denoted as 'x' in the equations). The document does not explicitly name the reference method, but states the device demonstrates "substantial equivalence to their respective predicate devices."

For the other analytical performance characteristics (Detection Limit, Accuracy, Precision, Measuring Range, Linearity, Stability), the "ground truth" would be established through a combination of:

Use of reference materials or calibrators with known analyte concentrations.
Comparison with established laboratory methods or predicate devices.
Internal validation procedures demonstrating adherence to pre-defined specifications.

8. Sample Size for the Training Set

This information is not provided and not applicable in the context of this traditional IVD product. Training sets are typically associated with machine learning or AI-based devices. This submission describes a chemical reagent and control.

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

This information is not provided and not applicable as there is no "training set" in the context of this device.

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