FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The pHoenix ISE Reagents for Olympus® AU Chemistry Systems are intended for use as ISE Reagents for the determination of Nat, K+, and Cli for the Olympus® AU Clinical Chemistry Systems.

The ISE Buffer is intended for use as a diluent for patient samples for the quantitative determination of Nat, K+ and Cl in serum by ISE.

The ISE Internal Reference Solution is intended as a means of compensating for calibration drift in the quantitative determination of Na * and Cl in serum samples on the Olympus® AU Chemistry Systems.

The ISE High and Low Standards are intended to provide calibration points for the Na , K+ and Cli Electrodes on the Olympus® AU ISE systems.

Device Description

The products encompassed by this 510 (k) submission are Class I (75JJG) and Class II (75 JIX) In Vitro Diagnostic Solutions manufactured by pHoenix Diagnostics, Inc., 8 Tech Circle, Natick, MA 01760. These pHoenix ISE Reagents are intended to serve as direct replacements to like named products manufactured by Olympus® Diagnostics. Listed below are pHoenix products and their Olympus® Diagnostics equivalents.

| pHoenix
Cat.# | Olympus
Cat. # | Description | Models | Class |
|------------------|-------------------|---------------------------------|--------|-------|
| TBD | AUH1011 | ISE Buffer | AU | 1 |
| TBD | AUH1017 | ISE Internal Reference Solution | AU | 1 |
| TBD | AUH1014 | ISE Low Standard | AU | 2 |
| TBD | AUH1015 | ISE High Standard | AU | 2 |

pHoenix uses a similar composition, description and packaging design as that used by Olympus® Diagnostics in its products.

AI/ML Overview

Here's an analysis of the provided information regarding the acceptance criteria and the study proving the device meets them:

Device: pHoenix ISE Reagents for Olympus® AU Chemistry Systems
Intended Use: For the determination of Na+, K+, and Cl- in serum by ISE. These reagents serve as direct replacements for Olympus® Diagnostics products.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" with numerical thresholds for performance. Instead, it demonstrates performance by comparing the pHoenix reagents to the predicate Olympus® Diagnostics reagents through method comparison (correlation) and precision studies. The implicit acceptance criteria are that the pHoenix reagents should perform comparably to the predicate device.

Given the absence of explicit acceptance criteria, I will infer them based on what is typically expected for a method comparison and precision study in in-vitro diagnostics, and then present the reported performance.

Performance Metric	Implicit Acceptance Criterion (Inferred)	Reported Device Performance (pHoenix Reagents)
Precision (CV%)	- Low CV% (e.g., 0.975 - 0.99) indicating strong agreement with the predicate.	Comparison with Olympus Diagnostics Standard Reagents:
(pHoenix vs. Olympus)

Na+: Slope = 1.06, Intercept = -4.9, Correlation Coefficient = 0.998
K+: Slope = 1.03, Intercept = 0.11, Correlation Coefficient = 0.999
Cl-: Slope = 0.98, Intercept = 4.8, Correlation Coefficient = 0.997 |

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

Precision Study Test Set:
- Sample Size:
  - 2 levels of serum controls
  - Measured 2 runs per day, 2 times per run for 20 days.
  - This results in: 2 levels * 2 runs/day * 2 measurements/run * 20 days = 160 individual measurements in total for each analyte. (The table lists N=80 for "Total" for each level, implying 80 measurements per level).
- Data Provenance: Not explicitly stated, but implies laboratory testing performance data rather than patient data from a specific country or retrospective/prospective collection of patient samples. The samples were "serum controls."
Method Comparison Study Test Set:
- Sample Size: 50 samples for each analyte (Na+, K+, Cl-).
- Data Provenance: The samples consisted of "patient serum samples, control samples and spiked samples." The origin (e.g., country) is not specified, nor is whether the collection was retrospective or prospective.

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

Not applicable in the conventional sense for this type of in-vitro diagnostic device (reagents for chemical analysis).
The "ground truth" for the method comparison is the results obtained using the legally marketed predicate device (Olympus® Diagnostics standard reagents) on an Olympus AU Clinical Chemistry System. This is a comparative study against an established, accepted method, not a subjective interpretation by experts.
For precision studies, the "ground truth" is the inherent variability of the analytical system, assessed statistically.

4. Adjudication Method for the Test Set

Not applicable. This is an analytical performance study for IVD reagents, not a study involving expert interpretation or medical imaging with subjective decision-making that would require adjudication.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for devices that involve human interpretation of results (e.g., medical imaging AI, pathology slides). The pHoenix ISE Reagents are for automated chemical analysis, where the result is a direct numerical output from the instrument.

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

Yes, in a sense. The performance presented (precision and method comparison) is that of the reagents and the analytical system (Olympus AU Chemistry Systems) calibrated with pHoenix reagents. There is no human interpretation component in the direct measurement process that these reagents support. The entire process is automated once the sample is loaded and the instrument is calibrated.

7. The Type of Ground Truth Used

Precision Study: Statistical measures of repeatability and reproducibility (Mean, STD, CV%). No external "ground truth" in the clinical sense, but rather a characterization of the system's inherent variation using control materials.
Method Comparison Study: The results generated by the predicate device (Olympus® Diagnostics standard reagents) on the Olympus AU Clinical Chemistry Systems. This is considered the "reference method" for comparison.

8. The Sample Size for the Training Set

Not applicable. This document describes performance verification studies for a chemical reagent, not a machine learning model that requires a "training set." The studies are designed to demonstrate the analytical performance of the product.

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

Not applicable, as there is no training set for this type of device.

Summary

Regulation Number and Section

§ 862.1170 Chloride test system.

(a)
Identification. A chloride test system is a device intended to measure the level of chloride in plasma, serum, sweat, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.(b)
Classification. Class II.