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The Beckman Coulter DxC 700 AU Clinical Chemistry Analyzer is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only. Applications include colorimetric, latex agglutination, and ion selective electrode.

The Glucose test system is for the quantitative measurement of glucose in human serum, plasma, urine and cerebrospinal fluid on Beckman Coulter AU analyzers. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemnia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

System reagent for the quantitative determination of C-Reactive Protein in human serum and plasma on Beckman Coulter AU Analyzers. Measurement of CRP is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases. Measurements may also be useful as an aid in the identification of individuals at risk for future cardiovascular disease. High sensitivity CRP (hsCRP) measurements, when used in conjunction with traditional clinical laboratory evaluation of acute coronary syndromes, may be useful as an independent marker of prognosis for recurrent events, in patients with stable coronary disease or acute coronary syndromes.

Reagents for the quantitative determination of Sodium, Potassium and Chloride concentrations in human serum, plasma and urine on the Beckman Coulter ISE modules.

The sodium test system is intended for the quantitative measurement sodium in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.

The potassium test system is intended for the quantitative measurement of potassium in serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels.

The chloride test system is intended for the quantitative measurement of the level of chloride in plasma, serum, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

The Beckman Coulter DxC 700 AU Clinical Chemistry Analyzer carries out automated analysis of serum, plasma, urine samples and other body fluids and automatically generates results. The device is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only. Applications include colorimetric, latex agglutination and ion selective electrode. Electrolyte measurement is performed using a single cell Ion Selective Electrode (ISE) which is also common among the other members of the AU family.

The ISE module for Na*, K*, and Cl employs crown ether membrane electrodes for sodium and potassium and a molecular oriented PVC membrane for chloride that are specific for each ion of interest in the sample. An electrical potential is developed according to the Nernst Equation for a specific ion. When compared to the Internal Reference Solution, this electrical potential is translated into voltage and then into the ion concentration of the sample.

In this Beckman Coulter procedure, glucose is phosphorylated by hexokinase (HK) in the presence of adenosine triphosphate (ATP) and magnesium ions to produce glucose-6-phosphate (G-6-P) and adenosine diphosphate (ADP). Glucose-6-phosphate dehydrogenase (G6P-DH) specifically oxidizes G-6-P to 6-phosphogluconate with the concurrent reduction of nicotinamide adenine dinucleotide (NAD+) to nicotinamide adenine dinucleotide, reduced (NADH).

The CRP Latex reagent is an in vitro diagnostic device that consists of ready to use buffer and latex particles coated with rabbit anti-CRP antibodies. Depending on the application used (different instrument settings), two measuring ranges are available: Normal application (CRP Concentrations ranging between 1.0-480 mg/L) and Highly Sensitive (Cardiac/ Neonatal) Application- (CRP concentrations ranging between 0.2- 80mg/L).

This document is a 510(k) Pre-Market Notification from Beckman Coulter for their DxC 700 AU Clinical Chemistry Analyzer and associated reagents (ISE Reagents, Glucose, and CRP Latex). This type of submission aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, rather than proving its safety and effectiveness de novo. Therefore, the "acceptance criteria" and "proof" are focused on demonstrating substantial equivalence through comparative performance testing against a predicate device, rather than setting absolute performance thresholds for a novel device.

The study proves the device meets the acceptance criteria by showing its performance is comparable to the predicate device (AU5800 Clinical Chemistry Analyzer) across various analytical parameters.

Here's a breakdown of the information as requested, largely based on the provided text, while noting the differences that arise from a 510(k) submission's nature:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission, the "acceptance criteria" are not absolute performance metrics but rather a demonstration that the new device performs similarly to or better than the predicate device. The goal is to show substantial equivalence. The tables below summarize the key performance parameters tested for the DxC 700 AU and its reagents against predicate devices/established guidelines. No explicit "acceptance criteria" values are stated in terms of thresholds, but meeting the "required specifications" (which would be internal to the manufacturer, often based on CLSI guidelines or clinical relevance) is implied by the "Pass" results.

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

The document describes the sample sizes specifically for the performance validation studies:

• Method Comparison and Bias Estimation: A minimum of 100 serum, urine, and CSF samples were tested over five days. "No more than 20% of samples were either spiked or diluted."
• Matrix Comparison (Anticoagulation Studies): For Glucose and CRP Latex (HS), 50 samples were tested for each anticoagulant type.
• Linearity/Assay Reportable Range: High and low pools were prepared and inter-diluted. Each dilution was assayed in quadruplicate.
• Sensitivity (Detection Limits): Total of 60 blank replicates per reagent lot (4 blank samples run 5-fold for 3 days) and 280 low level sample replicates per reagent lot (7 low level samples run 5-fold for 8 days) were generated. This was across 2 lots of reagent.
• Precision/Reproducibility: n=80 for each sample level (duplicate sample analysis, twice daily, over the course of 20 days). This implies a high number of individual measurements.
• In-Use and Calibration Stability Verification: Tested using one reagent lot (where appropriate) and one calibrator lot. Controls run in duplicate at each time point.
• Interferences: All test samples assayed in quadruplicate at two analyte levels.
• Prozone: Human serum was spiked to create a prozone pool. Eleven dilutions of the high prozone pool were then prepared and run n=3.

Data Provenance:
The document does not explicitly state the country of origin for the patient samples. The studies appear to be prospective as they involved specific experimental designs, preparation of samples (e.g., spiking, dilution), and controlled testing on the new DxC 700 AU analyzer and comparison to the predicate AU5800. The studies were conducted in a controlled laboratory setting by Beckman Coulter.

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

This document describes the analytical validation of an in vitro diagnostic (IVD) device, specifically a clinical chemistry analyzer and its reagents. For such devices, "ground truth" is typically established by:

• Reference Methods/Predicate Devices: The DxC 700 AU's performance is compared against its predicate device, the AU5800, which serves as the established "truth" or reference within the context of substantial equivalence.
• Clinically Accepted Norms/Guidelines: The studies follow CLSI (Clinical and Laboratory Standards Institute) guidelines (e.g., EP09-A3, EP06-A, EP17-A2, EP05-A3, EP25-A, EP07-A2). These guidelines represent consensus standards in laboratory medicine.

Therefore, this does not involve human experts (like radiologists reading images) establishing ground truth on a per-case basis. The "experts" are the scientific and medical community that developed and validated the methodologies in the CLSI guidelines, and the manufacturers who established the predicate device's performance.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1 or 3+1 consensus) are typically used in image-based diagnostic studies where human readers provide interpretations that need to be reconciled to establish a ground truth for a test set. This document is for a clinical chemistry analyzer and reagents. The "ground truth" (or reference values) for the measured analytes (Sodium, Potassium, Chloride, Glucose, CRP) are derived from the predicate device or established laboratory methods, and direct comparison of quantitative measurements. There is no human interpretation or adjudication of individual results described in the process of establishing ground truth for this type of IVD.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging AI systems where the AI assists human readers. For a clinical chemistry analyzer, the evaluation focuses on the analytical performance of the device itself (accuracy, precision, linearity, etc.) in quantifying specific analytes, and demonstrating equivalence to a predicate device. It's a direct measurement system, not an interpretive aid for human "readers".

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

Yes, in a sense, the entire analytical validation is a "standalone" performance evaluation of the DxC 700 AU Clinical Chemistry Analyzer and its reagents. The device operates automatically to measure analytes. The performance metrics (accuracy, precision, linearity, detection limits, interference) are all measures of the analyzer's inherent capability to produce a quantitative result, without human qualitative interpretation being part of the measurement process itself. The "human-in-the-loop" refers to the operator physically loading samples and calibrating the machine, but not to the diagnostic interpretation of each individual result by a human.

7. The Type of Ground Truth Used

The "ground truth" for the performance validation in this 510(k) submission is derived from:

• Measurement against a Predicate Device: The majority of the studies (e.g., Method Comparison) demonstrate that the DxC 700 AU produces results that are substantially equivalent to those obtained from the already legally marketed AU5800 Clinical Chemistry Analyzer. This served as the primary reference for comparison.
• Established Analytical Methods: For parameters like linearity, sensitivity, precision, and interference, the ground truth is against predefined analytical and statistical specifications and expected performance characteristics for such IVD assays, often guided by CLSI standards.
• Reference Materials: For linearity, "high and low pools" were prepared, which would have analytically defined concentrations. For sensitivity, "blank and low level samples" were used.

It is not based on expert consensus (like multiple clinical reads) or pathology/outcomes data in the way it would be for a diagnostic imaging device.

8. The Sample Size for the Training Set

This document describes the validation of a laboratory instrument and reagents, not a machine learning model. Therefore, there is no concept of a "training set" in the context of this 510(k) submission. The data presented are for Analytical Performance testing to demonstrate substantial equivalence to an existing predicate device.

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

As there is no "training set" for a machine learning model, this question is not applicable to the provided document.

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