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The S TEST Reagent Cartridge Blood Urea Nitrogen (BUN) is intended for the quantitative measurement of BUN in serum, lithium heparin plasma, K3 EDTA plasma, and sodium citrate plasma on the Hitachi Clinical Analyzer E40. The test system is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. BUN measurements are used in the diagnosis and treatment of certain renal and metabolic diseases.

The S TEST Reagent Cartridge Creatinine (CRE) is intended for the quantitative measurement of creatinine in serum, lithium heparin plasma, K3 EDTA plasma, and sodium citrate plasma on the Hitachi Clinical Analyzer E40. The test system is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

Device Description

The Hitachi Clinical Analyzer is an automatic, bench-top, wet chemistry system intended for use in clinical laboratories or physician office laboratories. The instrument consists of a desktop analyzer unit, an operations screen that prompts the user for operation input and displays data, a printer, and a unit cover. The analyzer unit includes a single probe, an incubation rotor, carousels for sample cups and reagent cartridges, and a multi-wavelength photometer. The single-use reagent cartridges may be placed in any configuration on the carousel, allowing the user to develop any test panel where the reagent cartridges are available.

The S TEST reagent cartridges are made of plastic and include two small reservoirs capable of holding two separate reagents (R1 and R2), separated by a reaction cell/photometric cuvette. The cartridges also include a dot code label that contains all chemistry parameters, calibration factors, and other production-related information, c.g., expiration dating, dimensions of the reagent cartridges are: 13.5 mm (W) × 28 mm (D) × 20.2 mm (H).

System operation: After the sample cup is placed into the carousel, the analyzer pipettes the sample, pipettes the reagent, and mixes (stirs) the sample and reagent together. After the sample and reagent react in the incubator bath, the analyzer measures the absorbance of the sample, and based on the absorbance of the reactions. it calculates the concentration of analyte in the sample. The test system can measure analytes in scrum or plasma and results are available in approximately 15 minutes per test. This submission is for reagent cartridge test systems for glucose.

AI/ML Overview

The provided text describes the performance of the Hitachi S TEST Reagent Cartridge Blood Urea Nitrogen (BUN) and S TEST Reagent Cartridge Creatinine (CRE) for use with the Hitachi Clinical Analyzer E40. These are in vitro diagnostic devices, not AI/ML-driven as commonly understood in medical imaging or other AI applications. Therefore, many of the requested categories (e.g., number of experts, adjudication method, MRMC study, training set ground truth) are not applicable to this type of device.

Below is a summary of the acceptance criteria and reported device performance based on the provided document, adapted for an in vitro diagnostic device regulatory submission.

1. Table of Acceptance Criteria and Reported Device Performance

Performance Characteristic	Acceptance Criteria (Implicit from Predicate/Study Design)	Reported Device Performance (BUN)	Reported Device Performance (CRE)
Analytical Sensitivity (LoD)	Comparable to predicate or suitable for intended use	0.8 mg/dL	0.1 mg/dL
Linearity/Reportable Range	Consistent linear correlation across dynamic range	Linear between 0.9 mg/dL and 110 mg/dL. Reportable range: 1.5 mg/dL to 80 mg/dL.	Linear between 0.1 mg/dL and 31.3 mg/dL. Reportable range: 0.1 mg/dL to 25 mg/dL.
In-house Precision (%CV)	Low %CVs indicating good reproducibility	Level 1: 5.0% (Total), Level 2: 2.7% (Total), Level 3: 2.3% (Total)	Level 1: 8.5% (Total), Level 2: 3.4% (Total), Level 3: 2.9% (Total), Level 4: 1.4% (Total)
Interference	No significant interference at specified levels (within 10% of neat)	Hemoglobin: no interference up to 1,000 mg/dL.
Unconjugated bilirubin: no interference up to 50 mg/dL.
Lipemia (Intralipid®): no interference up to 1,000 mg/dL.
Ascorbic acid: no interference up to 50 mg/dL.	Hemoglobin: no interference up to 250 mg/dL.
Unconjugated bilirubin: no interference up to 25 mg/dL.
Lipemia (Intralipid®): no interference up to 1,000 mg/dL.
Ascorbic acid: no interference up to 25 mg/dL.
Method Comparison (Regression)	High correlation (r-value close to 1), slope close to 1, intercept close to 0 compared to a standard lab system	n=162, r=0.997, Slope=0.96 (95% CI: 0.95 to 0.97), y-intercept=-0.27 (95% CI: -0.64 to 0.10)	n=100, r=0.999, Slope=0.99 (95% CI: 0.98 to 1.00), y-intercept=-0.13 (95% CI: -0.18 to -0.07)
Matrices Comparisons (Plasma vs. Serum Regression)	High correlation (r-value close to 1), slope close to 1, intercept close to 0 compared to serum	Heparinized: r=0.999, Slope=1.01 (-0.56 int.)
EDTA: r=0.999, Slope=1.01 (-0.61 int.)
Na Citrate: r=0.998, Slope=0.99 (-0.98 int.)	Heparinized: r=0.999, Slope=0.99 (-0.02 int.)
EDTA: r=0.999, Slope=1.01 (-0.06 int.)
Na Citrate: r=0.999, Slope=1.00 (-0.05 int.)
External Site Precision (%CV)	Demonstrates acceptable reproducibility in a POL setting	Site 1: 0.9-1.8% Total CV
Site 2: 1.2-3.6% Total CV
Site 3: 0.6-2.0% Total CV (across levels A, B, C)	Site 1: 2.1-6.8% Total CV
Site 2: 0.0-3.8% Total CV
Site 3: 4.4-6.7% Total CV (across levels A, B, C)
External Site Method Comparison (Regression)	High correlation (r-value close to 1), slope close to 1, intercept close to 0 compared to a reference method	Site 1: n=75, r=0.999, $y = 0.98x - 0.23$
Site 2: n=74, r=0.999, $y = 0.94x - 0.24$
Site 3: n=73, r=0.999, $y = 0.95x - 0.05$	Site 1: n=45, r=0.999, $y = 0.97x - 0.06$
Site 2: n=46, r=0.999, $y = 0.98x - 0.09$
Site 3: n=47, r=0.999, $y = 0.96x - 0.04$

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

Analytical Sensitivity (LoD): No specific sample size for a test set is provided, as this is typically determined by testing multiple replicates of low-concentration samples.
Linearity/Reportable Range: Not specified as a distinct "test set" sample size beyond the creation of concentration series.
20-day In-house Precision:
- BUN: n=80 per level (3 levels), so 240 measurements in total.
- CRE: n=80 per level (4 levels), so 320 measurements in total.
Interference Testing: Two serum pools per analyte, spiked with various concentrations of interfering substances. Specific number of total samples not explicitly stated but implies multiple measurements for each.
Method Comparison (Internal):
- BUN: 162 clinical specimens.
- CRE: 100 clinical specimens.
Matrices Comparisons:
- BUN: 36 matched serum/plasma samples.
- CRE: 39 matched serum/plasma samples.
External Site Precision: Each of 3 sites tested 3 blinded serum samples (low, middle, high levels) 6 times a day for 5 days. For each level, n=30 replicates per site.
External Site Method Comparison:
- BUN: Approximately 75 serum specimens at each of 3 sites (total ~225).
- CRE: Approximately 45 serum specimens at each of 3 sites (total ~135).

Data Provenance: The studies were performed "in-house" (Hitachi Chemical Diagnostics, Inc.) and at "three external POL-type sites" (Physician Office Laboratory). The clinical specimens are implied to be human serum or plasma. No country of origin is explicitly stated for the clinical data, but the company is in the USA. The studies are prospective in the sense that they were designed and executed to evaluate the device performance for this 510(k) submission.

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

This is not applicable to this type of in vitro diagnostic device. The "ground truth" for chemical analyzers is established through reference methods and calibrated samples, not expert consensus in the way a radiologist would interpret an image. The comparative methods used in the method comparison studies serve as the reference.

4. Adjudication Method for the Test Set

Not applicable. This is a quantitative chemical assay. Discrepancies are resolved through re-testing or investigation of analytical issues, not by expert adjudication of interpretations.

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 automated chemical analyzer, not an AI-assisted diagnostic imaging tool that involves human readers interpreting cases.

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

Yes, the device operates in a standalone (algorithm only) manner. It is an automated instrument that performs the assay and calculates results based on the detected absorbance. Humans are involved in operating the instrument, loading samples, and interpreting the numerical output, but the measurement and calculation itself is automated. The performance metrics listed (precision, linearity, method comparison, etc.) reflect this standalone analytical performance.

7. The Type of Ground Truth Used

The ground truth for evaluating the device's performance is established by:

Reference materials/calibrators: Used for linearity, detection limits, and precision studies.
Comparative methods/Standard laboratory systems: The results from the Hitachi system are compared against established, legally marketed systems (e.g., Roche Cobas c systems) which serve as the reference or "ground truth" for method comparison and accuracy studies. These are not "expert consensus, pathology, or outcomes data" in the traditional sense, but rather established analytical methods.

8. The Sample Size for the Training Set

Not applicable. This device is a wet chemistry system, not an AI/ML model that requires a training set in that context. The "training" of such a system involves chemical reagent formulation and instrument calibration, not data-driven model training.

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

Not applicable. As noted above, this is not an AI/ML model with a data-driven training set.

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