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The ISE Reagents are intended for use on the ISE Module of the BMD Hitachi Clinical Chemistry Systems. The ISE High and Low Calibrators are intended to provide calibration points for the Na +, K+, and Cl- Electrodes on the ISE Subsystem. The IN KCI Solutions are intended to provide stable reference potential for the Na +, K+, and Cl- Electrodes. The ISE Diluent dilutes all measured patient samples for the quantitative determination of Na +, K+, and Cl- in Serum, Plasma and Urine by ISE. The ISE Internal Reference Solutions are intended as a means of compensating for calibration drift in the quantitative determination of Na +, K+, and Cl- in Serum, Plasma and Urine samples on the BMD Hitachi Clinical Chemistry Systems.

All product(s) encompassed by this 510(k) submission are Class I (75JJG) and Class II (75JIX) In Vitro Diagnostic Solutions manufactured by ALKO Diagnostic Corporation. The ISE Reagents are intended for use on the ISE Module of the BMD Hitachi Clinical Chemistry Systems. The ISE High and Low Calibrators are intended to provide calibration points for the Na +, K+, and Cl- Electrodes on the ISE Subsystem. The IN KCI Solutions are intended to provide stable reference potential for the Na +, K+, and Cl- Electrodes. The ISE Diluent dilutes all measured patient samples for the quantitative determination of Na +, K+, and Cl- in Serum, Plasma and Urine by ISE. The ISE Internal Reference Solutions are intended as a means of compensating for calibration drift in the quantitative determination of Na +, K+, and Cl- in Serum, Plasma and Urine samples on the BMD Hitachi Clinical Chemistry Systems.

Here's an analysis of the acceptance criteria and study detailed in the provided text:

Device: ALKO Diagnostic Corporation ISE Reagents for BMD Hitachi Clinical Chemistry 700 Series and 911 Systems

Description of Device: ISE Reagents (Diluent, Internal Reference Solution, 1N KCI Solution, Low Standard, High Standard) intended for use on the ISE Module of BMD Hitachi Clinical Chemistry Systems for the quantitative determination of Na+, K+, and Cl- in Serum, Plasma, and Urine. They are designed as direct replacements for Boehringer Mannheim Diagnostic (BMD) products.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the sponsor's claim of "performance equivalence" to the predicate BMD reagents. The study aims to demonstrate that results obtained with ALKO reagents are comparable to those obtained with BMD reagents, and that ALKO reagents exhibit acceptable precision.

Performance Equivalence (Correlation Study):
The acceptance criteria are not explicitly stated as numerical thresholds (e.g., "slope must be between X and Y"). Instead, the document presents linear regression results (Slope, Intercept, R-squared) between ALKO and BMD reagents, implying that a slope close to 1, an intercept close to 0, and a high R-squared value (close to 1) indicate equivalence. For the purpose of this table, we will highlight the reported statistics.

Precision Study:
The acceptance criteria for precision are also not explicitly stated in numerical terms (e.g., "CV% must be < X%"). The reported data includes Total Standard Deviation (Ttl SD) and Total Coefficient of Variation (Ttl CV%), as well as Within-Run Standard Deviation (WR SD) and Within-Run Coefficient of Variation (WR CV%). The expectation is that these values should be within generally accepted limits for clinical chemistry assays, and the sponsor presents them as evidence of acceptable precision.

Study to Prove Device Meets Acceptance Criteria

The studies conducted are described as:

1. Comparative Analysis (Correlation Study): Comparing results from BMD Hitachi Chemistry Systems calibrated with ALKO products versus BMD products.
2. Precision Study: Measuring samples over 20 runs on BMD Hitachi Clinical Chemistry Systems with ALKO products.

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

• Correlation Study (Urine Samples):
  • Hitachi 736 System: N=40
  • Hitachi 704 System: N=40
  • Hitachi 737 System: N=42
  • Hitachi 911 System: N=42
• Correlation Study (Plasma Samples):
  • Hitachi 736 System: N=59
  • Hitachi 704 System: N=57 (Na, K); N=59 (Cl)
  • Hitachi 737 System: N=59
  • Hitachi 911 System: N=59
• Precision Study (Urine Samples): For each analyte (Na, K, Cl) at two levels (Level 1, Level 2) on systems 704, 717, 736, and 737, the sample size (N) is 20.

Data Provenance: Not explicitly stated in the provided text. It is a retrospective analysis comparing against an existing predicate. The document refers to "samples measured on Hitachi..." suggesting patient samples were collected and analyzed. No mention of country of origin.

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

N/A. This is a study comparing analytical reagent performance, not an AI or diagnostic imaging device requiring expert interpretation for ground truth. The "ground truth" for the correlation study is the measurement obtained using the predicate (BMD) reagents.

4. Adjudication Method for the Test Set

N/A. Not applicable for this type of analytical performance study. The adjudication is the agreement between the ALKO and BMD reagent measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

N/A. This is not an MRMC study. It is an analytical performance study of reagents.

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

N/A. This is not an AI or algorithm-based device. It's a chemical reagent. The performance described is the standalone performance of the ALKO reagents in terms of their analytical output on the specified instruments.

7. The Type of Ground Truth Used

For the correlation study, the ground truth is the measurements obtained using the Boehringer Mannheim Diagnostic (BMD) predicate reagents on the same Hitachi Clinical Chemistry Systems. This is a comparative type of ground truth where the new device's performance is gauged against an established, accepted method.

For the precision study, the ground truth is implicitly the statistical expectation of minimal variability around the mean value of repeated measurements of the same sample. There isn't an external "ground truth" measurement, but rather an assessment of the consistency of the device's own measurements.

8. The Sample Size for the Training Set

N/A. This is not a machine learning or AI device that requires a training set. The reagents are chemical formulations.

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

N/A. Not applicable.

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