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510(k) Data Aggregation
(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 | < 10% bias or clinically insignificant interference at stated concentrations | Ascorbic acid: none Bilirubin: -3.3 mg/dL, -3.6% Hemoglobin: -3.6 mg/dL, -3.8% Lipemia: +4 mg/dL, +3.9% Metronidazole: +2.4 mg/dL, +3.1% Tetracycline: none |
2. Sample Size Used for the Test Set and Data Provenance
- Method Comparison: The document does not explicitly state the total number of samples used for the method comparison (correlation analysis) with the Beckman CX-7.
- Precision (Repeatability): 60 replicates for each of 5 serum samples.
- Precision (Total Imprecision): 80 replicates for each of 4 samples (2 controls, 2 serum pools) on each of two different analyzers.
- Linearity: The sample size for the linearity study is not explicitly stated, but it covered a range of 25 - 500 mg/dL.
- Interferences: The sample sizes for the interference study are not explicitly stated, but tests were performed at two glucose concentrations (e.g., 75 mg/dL and 140 mg/dL for Ascorbic acid).
- Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective clinical studies. Given the manufacturer's location (Japan) and the context of typical lab instrument validation, these are likely prospective laboratory studies rather than large-scale clinical trials. The samples used (serum, controls, serum pools) suggest laboratory-generated or purchased materials.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This device is a clinical chemistry analyzer, which measures quantitative values of analytes. The "ground truth" for such devices is established by reference methods or validated calibrated materials, not typically by human expert consensus or adjudication on individual cases.
- For Method Comparison: The "ground truth" was essentially the measurements obtained from the predicate device, the Beckman CX-7.
- For Calibration: The calibrator (Pointe Scientific Chemistry Calibrator) was verified against NIST SRM 965b (Glucose in Frozen Serum), which serves as a highly reliable reference.
- No human experts were used to establish the ground truth for the analytical performance of the test set in this context.
4. Adjudication Method for the Test Set
Not applicable. As noted above, the ground truth for this type of device is established by reference methods/calibrators, not by human expert adjudication of individual cases.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is not relevant for a standalone clinical chemistry analyzer. MRMC studies are typically used for diagnostic imaging devices where human readers interpret images or data, and the effect of AI assistance on their performance is evaluated. This device provides a quantitative measurement directly.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, this entire submission focuses on the standalone performance of the Biolis 24i analyzer as a device for measuring glucose quantitatively. There is no human-in-the-loop component in its measurement principle; it is an automated instrument.
7. The Type of Ground Truth Used
The ground truth used was based on:
- Reference measurements from a predicate device (Beckman CX-7) for method comparison studies.
- NIST Standard Reference Material (SRM 965b, Glucose in Frozen Serum) for verifying the calibrator used to establish the measurement accuracy.
- Known concentrations in control materials and serum pools for precision studies.
8. The Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of device development. Clinical chemistry analyzers are typically developed and validated using well-established analytical principles and internal testing, calibration, and verification processes rather than machine learning "training sets" in the way an AI algorithm might have one. The "training" would refer to the calibration of the instrument using known calibrators. The text states:
- The calibrator (Pointe Scientific Chemistry Calibrator) was assayed eight times over each of four analytical runs against NIST standard levels 3 and 4, each assayed in duplicate. This process helps "train" or verify the calibration curve for the device.
9. How the Ground Truth for the Training Set Was Established
As mentioned above, the "training" in this context refers to the calibration and verification process. The ground truth for the calibrator was established by comparing it to NIST SRM 965b, Glucose in Frozen Serum, which has certified glucose values (118.5 mg/dL and 294.5 mg/dL). This comparison allowed for the verification of the 185 mg/dL glucose set point for the Pointe Calibrator.
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