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The pHoenix ISE Reagents for Beckman CX Systems are intended for use as ISE Reagents for the determination of Na , K , C1 and C02 in human serum samples on the Beckman CX Systems.

The Electrolyte Buffer is diluted with the Wash Solution and introduced into the serum samples for the quantitative determination of Na+, K+, Cl- and C02.

The Electrolyte Reference Reagent is to provide reference points for Na+, K+, C1- and C02.

The C02 Acid Reagent is to release C02 from serum samples.

The C02 Alkaline Buffer is to provide a constant C02 concentration as reference for the C02 electrode. The Wash Concentrate is intended to be diluted with de-ionized water. The working Wash Solution is used to wash the systems sample probe and to dilute reagents on Beckman CX Systems.

The Calibrators are used for the calibration of the CX ISE Modules for the quantitative determination of Na+, K+ Cl+and C02 in serum samples.

pHoenix Diagnostics, Inc. is submitting a 510 (k) notification for the following: (1) Electrolyte Buffer, (2) Electrolyte Reference Reagent and (3) C02 Acid Reagent, (4) C02 Alkaline Buffer, (5) Wash Concentrate and (6) ISE Calibrator Level 1,2 and 3. These ISE Reagents are intended for use on the ISE Module of the Beckman CX Systems for the quantitative determination of Na+, K+, C1- and C02 in human serum.

The Electrolyte Buffer is intended to provide constant ionic strength for measuring electrolytes in human serum samples. The Electrolyte Buffer is combined with the Wash Solution and introduced into the serum samples for the quantitative determination of Na+, K+, C1- and C02. The Electrolyte Reference Reagent is to provide reference points for Na+, K+, C1- and C02. The C02 Acid Reagent is to release C02 from serum samples, The C02 Alkaline Reagent is to provide a constant C02 concentration as reference for the C02 electrode. The Wash Concentrate is intended to be diluted with de-ionized water. The working Wash Solution is used to wash the systems sample probe and to dilute reagents on Beckman CX Systems. The Calibrators are used for the calibration of the CX ISE Modules.

1. Table of Acceptance Criteria and Reported Device Performance

The device is a set of reagents for an In Vitro Diagnostic (IVD) system. Performance is primarily evaluated through precision and correlation studies against a predicate device.

Note: The document does not explicitly state acceptance criteria in numerical terms. The "acceptance criteria" presented above are inferred from the stated goal of demonstrating "performance equivalence" to the predicate devices and the robust correlation coefficients and low CV% values typically expected for IVD assays.

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

• Precision Study:
  • Sample Size: For each analyte (Na+, K+, Cl-, CO2), two levels of serum controls were measured. Each level had 80 total measurements (2 runs per day, 2 times per run for 20 days).
  • Data Provenance: The document states "Typical Results are as follows," suggesting the data was generated specifically for this submission. The origin of the serum controls (e.g., country) is not specified. It is a prospective study as the testing was conducted using the pHoenix reagents on Beckman CX Systems.
• Correlation Study:
  • Sample Size: 50 samples were used for each analyte (Na+, K+, Cl-, CO2).
  • Data Provenance: The samples included "patient serum samples, control samples and spiked samples." The country of origin is not specified. This is a prospective study as the measurements were taken using pHoenix reagents and compared to measurements with Beckman Coulter reagents on the same analyzer.

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

Not applicable. This device is an IVD reagent set, and the "ground truth" for performance studies (precision and correlation) is based on quantitative measurements generated by laboratory instruments, not expert interpretation. The comparison is made against a legally marketed predicate device (Beckman Coulter reagents).

4. Adjudication Method for the Test Set

Not applicable. As noted above, performance is based on quantitative laboratory measurements, not subjective interpretation requiring adjudication among experts.

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

Not applicable. This device is an IVD reagent set, not an AI-powered diagnostic imaging or interpretation tool. The study focuses on the analytical performance of the reagents.

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

Not applicable. This device is an IVD chemical reagent set. Its performance inherently involves an instrument (Beckman CX Systems) and a human operator to perform the tests, although the performance data collected (precision and correlation) represents the analytical performance of the reagents themselves.

7. The Type of Ground Truth Used

For the precision study, the ground truth is the quantitative measurement obtained over multiple runs, and the benchmark is the expected variability for such assays (as indicated by NCCLS Guideline EP5-T). For the correlation study, the "ground truth" for comparison is the results obtained using the legally marketed predicate Beckman Coulter reagents. This is a comparative study against an established method.

8. The Sample Size for the Training Set

Not applicable. This document describes the validation of an IVD reagent set, not a machine learning model. There is no concept of a "training set" in this context. The reagents themselves are "trained" through their manufacturing process to consistently produce accurate results.

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

Not applicable. (See #8).

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