The BS-400/CLC 720 Chemistry Analyzers are 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 plasma and urine 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-400/CLC 720 Chemistry Analyzer is an automated clinical chemistry analyzer capable of performing various in vitro photometric assays. The Glucose was cleared under K970664 and is the chosen assay to demonstrate performance for the photometric unit. The BS-400 Chemistry Analyzer has an optional lon-Selective Electrode (ISE) module which measures the concentration of the electrolytes, sodium, potassium, and chloride, in samples using ion selective electrode technology.
Here's an analysis of the provided 510(k) summary, extracting the requested information about the device's acceptance criteria and the supporting study:
The document describes the Shenzhen Mindray Bio-medical Electronics Co., LTD BS-400 Chemistry Analyzer (and CLC 720 Chemistry Analyzer, which is stated to be the same model). The device is an automated clinical chemistry analyzer for in vitro diagnostic use, performing photometric assays and having an optional Ion-Selective Electrode (ISE) module.
Summary of Acceptance Criteria and Device Performance:
The primary method for demonstrating performance is through correlation analysis with predicate devices and internal precision, linearity, and limit determination tests. The acceptance criteria are implicitly defined by the reported performance metrics falling within acceptable ranges for clinical diagnostic devices.
| Performance Characteristic | Analyte | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|---|
| Correlation Coefficient (R²) | GLU (mg/dL) | Close to 1.0 | 0.999 |
| Serum K+ (mmol/L) (ISE) | Close to 1.0 | 0.9973 | |
| Serum Na+ (mmol/L) (ISE) | Close to 1.0 | 0.9975 | |
| Serum Cl- (mmol/L) (ISE) | Close to 1.0 | 0.9957 | |
| Urine K+ (mmol/L) (ISE) | Close to 1.0 | 0.9996 | |
| Urine Na+ (mmol/L) (ISE) | Close to 1.0 | 0.9994 | |
| Urine Cl- (mmol/L) (ISE) | Close to 1.0 | 0.9996 | |
| Within Run Precision (%CV) | Glucose (ranges by concentration) | Low %CV | 0.6% - 1.7% |
| ISE analytes (ranges by level) | Low %CV | 0.33% - 2.48% | |
| Total Precision (%CV) | Glucose (ranges by concentration) | Low %CV | 0.9% - 2.1% |
| Between-Run Imprecision (%CV) | ISE analytes (ranges by level) | Low %CV | 0.56% - 4.75% |
| Linearity Range (Lower/Upper Limits) | GLU (mg/dL) Serum/Plasma | Defined clinical range | 5 - 700 |
| GLU (mg/dL) Urine | Defined clinical range | 2 - 700 | |
| K (mmol/L) serum(ISE) | Defined clinical range | 0.94 - 8.18 | |
| Na (mmol/L) serum(ISE) | Defined clinical range | 71.00 - 232.28 | |
| CL (mmol/L) serum(ISE) | Defined clinical range | 49.60 - 198.18 | |
| K (mmol/L) Urine(ISE) | Defined clinical range | 3.50 - 209.25 | |
| Na (mmol/L) Urine(ISE) | Defined clinical range | 9.25 - 725.50 | |
| CL (mmol/L) Urine(ISE) | Defined clinical range | 7.25 - 693.25 | |
| Limit of Detection (LoD) | GLU (mg/dL) Serum/Urine | Low LoD | 2.6 / 0.9 |
| ISE analytes | Low LoD | 0.10 - 8.98 | |
| Interference (Implicit Criterion) | Shift in results |
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. 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.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.