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The BS-200 Chemistry Analyzer is an automated chemistry analyzer for in vitro diagnostic use in clinical laboratories. The analyzer is designed for the in vitro quantitative determination of clinical chemistries in serum, plasma, urine or cerebral spinal fluid samples.

The BS-200 Chemistry Analyzer is designed for clinical laboratory use, making direct quantitative measurements of Na+ (sodium), K+ (potassium), Cl-(chloride) in serum, plasma and urine samples and Glucose in serum samples. Additionally, other various chemistry assays may be adaptable to the analyzer depending on the reagent used to induce a photometric reaction.

Sodium measurements are used in the diagnosis and treatment diseases involving electrolyte imbalance.

Potassium measurements monitor electrolyte balance and in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.

Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders.

Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

The BS-200 Chemistry Analyzer is an automated clinical chemistry analyzer capable of performing various in vitro photometric assays. The Glucose was cleared under K002199 and is the chosen assay to demonstrate performance for the photometric unit. The BS-200 Chemistry Analyzer has an optional Ion-Selective Electrode (ISE) module which measures the concentration of the electrolytes, sodium, potassium, and chloride, in samples using ion selective electrode technology.

The provided text describes the performance characteristics of the BS-200 Chemistry Analyzer through various tests, including precision, linearity, method comparison, limits of detection, and interference. However, it does not explicitly state predetermined "acceptance criteria" for these performance metrics. Instead, it presents the reported performance values without defining specific thresholds for approval. The study aims to demonstrate substantial equivalence to predicate devices.

Here's an analysis based on the provided text, addressing your points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, explicit "acceptance criteria" are not provided in the text. The table below lists the reported performance data. The implicit acceptance criterion is that these reported performances demonstrate "substantial equivalence" to the predicate devices.

| Performance Metric | Analytes/Levels | Reported Device Performance |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Method Comparison (Correlation with Predicate Device) | GLU (mg/dL) | Slope: 1.015, Intercept: -0.0288, Correlation Coefficient (r): 0.9992 |
| | K (mmol/L) serum(ISE) | Slope: 0.9864, Intercept: 0.1226, Correlation Coefficient (r): 0.9980 |
| | Na (mmol/L) serum(ISE) | Slope: 0.9903, Intercept: 1.3158, Correlation Coefficient (r): 0.9845 |
| | CL (mmol/L) serum(ISE) | Slope: 0.9815, Intercept: 3.4021, Correlation Coefficient (r): 0.9905 |
| | K (mmol/L)Urine(ISE) | Slope: 0.9668, Intercept: 0.5307, Correlation Coefficient (r): 0.9991 |
| | Na (mmol/L) Urine(ISE) | Slope: 0.9479, Intercept: -3.1284, Correlation Coefficient (r): 0.9977 |
| | CL (mmol/L)Urine(ISE) | Slope: 1.001, Intercept: -6.9595, Correlation Coefficient (r): 0.9887 |
| Within-Run Precision (CV%) | Glucose (Level I: 55.9 mg/dL) | 0.9% |
| | Glucose (Level II: 121.5 mg/dL) | 0.6% |
| | Glucose (Level III: 295.63 mg/dL) | 0.5% |
| | K serum(ISE) (Level I: Mean ≈ 3.7) | 0.7% |
| | K serum(ISE) (Level II: Mean ≈ 6.77) | 0.8% |
| | Na serum(ISE) (Level I: 136.13) | 0.4% |
| | Na serum(ISE) (Level II: 146.74) | 0.5% |
| | CL serum(ISE) (Level I: 99.59) | 0.7% |
| | CL serum(ISE) (Level II: 115.68) | 0.5% |
| | K Urine(ISE) (Level I: 37.09) | 1.2% |
| | K Urine(ISE) (Level II: 67.49) | 0.9% |
| | Na Urine(ISE) (Level I: 99.23) | 1.1% |
| | Na Urine(ISE) (Level II: 170.84) | 0.8% |
| | CL Urine(ISE) (Level I: 82.90) | 1.6% |
| | CL Urine(ISE) (Level II: 132.16) | 0.9% |
| Between-Run Precision (CV%) | Glucose (Level I: 55.9 mg/dL) | 2.7% |
| | Glucose (Level II: 121.5 mg/dL) | 2.0% |
| | Glucose (Level III: 295.63 mg/dL) | 1.8% |
| | K serum(ISE) (Level I: 4.11 mmol/L) | 1.6% |
| | K serum(ISE) (Level II: 6.77 mmol/L) | 1.0% |
| | Na serum(ISE) (Level I: 136.13 mmol/L) | 1.6% |
| | Na serum(ISE) (Level II: 146.74 mmol/L) | 1.1% |
| | CL serum(ISE) (Level I: 99.59 mmol/L) | 1.8% |
| | CL serum(ISE) (Level II: 115.68 mmol/L) | 1.0% |
| | K Urine(ISE) (Level I: 37.09 mmol/L) | 1.3% |
| | K Urine(ISE) (Level II: 67.49 mmol/L) | 1.0% |
| | Na Urine(ISE) (Level I: 99.23 mmol/L) | 1.7% |
| | Na Urine(ISE) (Level II: 170.84 mmol/L) | 1.4% |
| | CL Urine(ISE) (Level I: 82.90 mmol/L) ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| 1.8% |
| | CL Urine(ISE) (Level II: 132.16 mmol/L) -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| 1.6% |
| Linearity Range | GLU (mg/dL) -----------------------------------------------------------------------------| Lower limit: 1, Upper limit: 686 |
| | K (mmol/L) serum(ISE) -----------------------------------------------------------------------------| Lower limit: 1.1, Upper limit: 8.6 |
| | Na (mmol/L) serum(ISE) -----------------------------------------------------------------------------| Lower limit: 113, Upper limit: 194 |
| | CL (mmol/L) serum(ISE) -----------------------------------------------------------------------------| Lower limit: 53, Upper limit: 154 |
| | K (mmol/L)Urine(ISE) -----------------------------------------------------------------------------| Lower limit: 13, Upper limit: 184 |
| | Na (mmol/L) Urine(ISE) -----------------------------------------------------------------------------| Lower limit: 27, Upper limit: 372 |
| | CL (mmol/L)Urine(ISE) -----------------------------------------------------------------------------| Lower limit: 42, Upper limit: 422 |
| Limit of Detection | GLU (mg/dl) -----------------------------------------------------------------------------| LoB: 0.04, LoD: 0.22, LoQ: 0.97 |
| | K (mmol/L) serum (ISE) -----------------------------------------------------------------------------| LoB: 0.1, LoD: 0.16, LoQ: 0.42 |
| | Na (mmol/L) serum(ISE) -----------------------------------------------------------------------------| LoB: 1.15, LoD: 2.67, LoQ: 5.3 |
| | CL (mmol/L) serum (ISE) -----------------------------------------------------------------------------| LoB: 2.95, LoD: 5.0, LoQ: 12.0 |
| | K (mmol/L)Urine(ISE) -----------------------------------------------------------------------------| LoB: 0.26, LoD: 0.58, LoQ: 1.34 |
| | Na (mmol/L) Urine(ISE) -----------------------------------------------------------------------------| LoB: 5.85, LoD: 8.27, LoQ: 22.2 |
| | CL (mmol/L)Urine(ISE) -----------------------------------------------------------------------------| LoB: 4.5, LoD: 6.29, LoQ: 17.1 |
| Interference | GLU (mg/dl) -----------------------------------------------------------------------------| Hemoglobin: 250mg/dl, Bilirubin: 18 mg/dl, Intralipids®: 300mg/dl (no interference at these levels) |
| | K (mmol/L) serum(ISE) -----------------------------------------------------------------------------| Hemoglobin: >500mg/dl, Bilirubin: >20mg/dl, Intralipids®: >1000 mg/dl (no interference at these levels) |
| | Na (mmol/L) serum(ISE) -----------------------------------------------------------------------------| Hemoglobin: >500mg/dl, Bilirubin: >20mg/dl, Intralipids®: >1000 mg/dl (no interference at these levels) |
| | CL (mmol/L) serum(ISE) -----------------------------------------------------------------------------| Hemoglobin: >500mg/dl, Bilirubin: >20mg/dl, Intralipids®: >1000 mg/dl (no interference at these levels) |

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

• Sample Sizes:
  • Method Comparison: 60 samples for Glucose, 40 samples for K, Na, and Cl in serum, and 40 samples for K, Na, and Cl in urine.
  • Precision (Within-Run & Between-Run): Three levels tested for Glucose and two levels for ISE chemistries. The exact number of replicates per level is not specified, but typically precision studies involve multiple replicates over several days.
  • Linearity, Limit of Detection, Interference: Sample sizes for these tests are not explicitly stated.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable to this type of device and study. This is a clinical chemistry analyzer, and the "ground truth" for its performance is typically established by reference methods or validated predicate devices, not by human expert interpretation for subjective analysis.

4. Adjudication Method for the Test Set

This is not applicable. The data presented are quantitative measurements from a chemistry analyzer, not qualitative assessments requiring adjudication by experts.

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

This is not applicable. An MRMC study involves human readers interpreting cases/images, often with and without AI assistance, to assess the impact of AI on reader performance. This study is for a clinical chemistry analyzer, which provides automated quantitative results, not interpretations by human readers.

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

Yes, this study is inherently a standalone performance evaluation. The BS-200 Chemistry Analyzer is an automated device designed to produce quantitative results directly. The performance tests (precision, linearity, limits of detection, interference, and comparison to predicate devices) all evaluate the algorithm's and the device's ability to accurately measure without human intervention in the measurement process itself.

7. The Type of Ground Truth Used

The "ground truth" in this context is established by:

• Comparison to Legally Marketed Predicate Devices: The primary method for demonstrating substantial equivalence is by comparing the BS-200 Chemistry Analyzer's results to those obtained from the previously cleared Boehringer Mannheim/Hitachi 917 Analyzer (for photometric assays like Glucose) and the EasyElectroLyte/RapidLyte Na/K/Cl Analyzer (for ISE assays). The predicate devices serve as the reference for accurate measurement.
• Internal Validation Studies: Precision, linearity, limits of detection, and interference studies demonstrate the device's inherent analytical performance, with the understanding that these metrics are typically verified against established laboratory standards and methods.

8. The Sample Size for the Training Set

This information is not provided and is generally not relevant for 510(k) submissions of traditional clinical chemistry analyzers. These devices are typically developed and calibrated based on established chemical principles and known concentrations, rather than being "trained" in the machine learning sense on a large dataset.

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

This information is not provided and is likely not applicable as per the explanation in point 8. The "training" in such devices involves calibration using materials with known, precisely determined concentrations, which serve as the reference standard.

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