(408 days)
The XL-200 Clinical Chemistry Analyzer is an automated random access, computer controlled, bench top, clinical analyzer for clinical chemistry tests. The instrument provides in vitro quantitative measurements for glucose, sodium, potassium and chloride in serum. This device is intended for clinical laboratory use.
The JAS Glucose Reagent is intended for the in vitro quantitative measurement of glucose in serum on the XL-200 clinical chemistry analyzer. This device is intended for clinical laboratory use. 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 ISE Reagent Pack is intended for the in vitro quantitative measurement of sodium, and chloride concentrations in serum on the XL-200 clinical chemistry analyzer. This device is intended for clinical laboratory use.
Sodium measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus and other diseases involving electrolyte imbalance.
Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels.
Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
The XL-200 Clinical Chemistry Analyzer is an automated bench top, random access, open analyzer for clinical chemistry and immunoturbidimetric analysis on serum, urine, and other body fluids. The analyzer mainly uses colorimetric, turbidimetric, and ion selective electrode methods for analysis of samples.
The instrument includes of the following main parts;
- . Sampling Arm (for sample addition to cuvettes)
- Reagent Arm (for reagent addition to cuvettes) .
- Reaction Station (cuvettes) .
- Sample Plate Station (for loading samples) .
- Reagent Plate Station (for on board reagents) .
- . Photometer (for reaction analysis reading)
- Wash Station (for cleaning of reaction cuvettes) .
- Electronic Boards (for controlling the open functions) .
The JAS Glucose Reagent is intended for the quantitative measurement of glucose in serum on the XL-200 Clinical Chemistry Analyzer. The Reagent is a single vial liquid that is placed for use on the XL-200 Clinical Chemistry Analyzer reagent carousel. The reagent uses the enzymatic (Hexokinase/G-6-P) UV (340nm) method. This device is for clinical laboratory use.
The JAS ISE Module consists of ion selective electrodes for sodium, potassium, and chloride, a reference electrode and accessory reagents.
Here's a breakdown of the acceptance criteria and study information for the JAS XL-200 Clinical Chemistry Analyzer, JAS Glucose Reagent, and ISE Reagent Pack, based on the provided text:
Important Note: The provided document is a 510(k) summary for a medical device. This type of document focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical trials. Therefore, information regarding human reader studies (MRMC), standalone AI performance, and expert qualifications for ground truth in the traditional sense of AI/ML studies are not typically found in these submissions as the device is not an AI/ML diagnostic tool. The "ground truth" here refers to established, validated reference methods or materials in clinical chemistry.
1. Table of Acceptance Criteria and Reported Device Performance
Device: XL-200 Clinical Chemistry Analyzer, JAS Glucose Reagent, ISE Reagent Pack
Tests: Glucose, Sodium, Potassium, Chloride
| Performance Characteristic | Acceptance Criteria (Implicit from Results) | Reported Device Performance (Glucose) | Reported Device Performance (Sodium) | Reported Device Performance (Potassium) | Reported Device Performance (Chloride) |
|---|---|---|---|---|---|
| Linearity | Data linear within allowable nonlinearity (e.g., 3mg/dL or 5%) | 9 to 500 mg/dL | 100 to 200 mEq/L | 1.0 to 10.0 mEq/L | 50 to 150 mEq/L |
| Slope between 0.90 and 1.10 | 1.001 (Glucose linearity) | - | - | - | |
| Intercept close to 0 mg/dL | -0.1 mg/dL (Glucose linearity) | - | - | - | |
| Calibrator Traceability Accuracy | "Accuracy test passed and results linear" with acceptable slope and intercept. | Slope: 0.972, Intercept: 2.1mg/dL, Error: 1.4% | Slope: 1.007, Intercept: 4.4mmol/L, Error: 0.1% | Slope: 0.902, Intercept: 0.1mmol/L, Error: 1.3% | Slope: 1.012, Intercept: 2.0mmol/L, Error: 1.3% |
| Interferences | Glucose values remain within 10% of unspiked sample value. | Hemoglobin: up to 400 mg/dLBilirubin: up to 21.4 mg/dLLipemia: up to 412 mg/dLAscorbic Acid: up to 10.0 mg/dL | Hemolyzed samples should not be usedLipemia: up to 1084 mg/dL*Bilirubin: up to 22.5 mg/dL | Hemolyzed samples should not be usedLipemia: up to 1084 mg/dL*Bilirubin: up to 22.5 mg/dL | Hemolyzed samples should not be usedLipemia: up to 1084 mg/dL*Bilirubin: up to 22.5 mg/dL |
| Method Comparison (Correlation) | R > 0.95, Slope between 0.90 and 1.10, Intercept close to 0 | R: 0.9970, Slope: 1.002, Intercept: 1.8 mg/dL (vs. Olympus 400 Glucose Reagent) | R: 0.9917, Slope: 0.984, Intercept: 2.256 mmol/L (vs. Olympus 400 ISE) | R: 0.9954, Slope: 0.999, Intercept: 0.05 mmol/L (vs. Olympus 400 ISE) | R: 0.9856, Slope: 1.070, Intercept: -4.3 mmol/L (vs. Olympus 400 ISE) |
| Precision/ Reproducibility (CV%) | CV (%) |
§ 862.2160 Discrete photometric chemistry analyzer for clinical use.
(a)
Identification. A discrete photometric chemistry analyzer for clinical use is a device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes. Different models of the device incorporate various instrumentation such as micro analysis apparatus, double beam, single, or dual channel photometers, and bichromatic 2-wavelength photometers. Some models of the device may include reagent-containing components that may also serve as reaction units.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.