(365 days)
The Biolis 24i Clinical Chemistry Analyzer is a discrete photometric clinical chemistry analyzer. The device is intended to duplicate manual analytical procedures by automating various steps such as pipetting, heating, measuring color intensity, and reporting results. The device is intended to be used with certain materials to measure various analytes of diagnostic interest including glucose.
The Biolis 24i analyzer with glucose hexokinase assay is intended to measure glucose quantitatively in human serum. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic glycemia, and of the pancreatic islet cell carcinoma.
Using photometry, the Biolis 24i instrument measures the glucose concentration in serum by monitoring the change in absorbance at 340 nm. Additionally, the Biolis 24i with Ion-Selective Elective module additionally measures the concentration of the electrolytes, sodium, potassium and chloride in serum, using indirect potentiometry.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Tokyo Boeki Medisys Inc. Biolis 24i Clinical Chemistry Analyzer, specifically for glucose measurement:
Acceptance Criteria and Device Performance for Biolis 24i Clinical Chemistry Analyzer (Glucose)
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state pre-defined acceptance criteria values for each performance characteristic. Instead, it presents the results of the performance studies and implicitly suggests that these results demonstrated substantial equivalence to the predicate device. For the purpose of this response, I infer the reported performance as the outcome that met the (unspecified) acceptance criteria for substantial equivalence.
| Performance Characteristic | Acceptance Criteria (Inferred) | Reported Device Performance (Biolis 24i) |
|---|---|---|
| Method Comparison (vs. Predicate SYNCHRON CX 7) | Correlation Coefficient (R) close to 1 | GLU: 0.999 |
| Slope (Least-Squares) close to 1 | GLU: 0.974 | |
| Y-axis intercept close to 0 | GLU: 2.22 | |
| Precision (Repeatability) | Low Coefficient of Variation (CV%) | Serum 1: 1.3% |
| Serum 2: 1.3% | ||
| Serum 3: 1.2% | ||
| Serum 4: 1.1% | ||
| Serum 5: 1.5% | ||
| Precision (Total Imprecision) | Low Coefficient of Variation (CV%) | Analyzer 2229450610: |
| Control 1: 2.4% | ||
| Serum Pool 1: 2.5% | ||
| Serum Pool 2: 2.1% | ||
| Control 2: 2.3% | ||
| Analyzer 2227671109: | ||
| Control 1: 1.9% | ||
| Serum Pool 1: 2.3% | ||
| Serum Pool 2: 1.9% | ||
| Control 2: 2.2% | ||
| Linearity | Correlation close to 1 | 0.9982 |
| Slope close to 1 | 0.948 | |
| Intercept close to 0 | 2.45 | |
| Range of linearity | 25 - 500 mg/dL | |
| Sensitivity | Low values for LoB, LoD, LoQ | LoB: 3.64 mg/dL |
| LoD: 5.64 mg/dL | ||
| LoQ: 10 mg/dL | ||
| Interferences |
§ 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.