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510(k) Data Aggregation
(257 days)
The GenChem Glucose Oxidase Reagent is for the quantitative determination of glucose in serum, plasma, urine and cerebrospinal fluid on the Beckman SYNCHRON CX3® System to aid in the diagnosis of diabetes, liver disease and certain endocrine disorders.
The Device is a solution containing sufficient Glucose Oxidase, surfactants and other ingredients necessary for optimum system operation on the Beckman CX3® Analyzer.
This submission pertains to the GenChem Glucose Oxidase Reagent for the quantitative determination of glucose. The study evaluates the device's performance against predefined criteria across various metrics.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Precision/Reproducibility | ||
| Serum Glucose (60mg/dL) | Low %CV for within-run and total imprecision | Within Run: 1.4%CV; Total: 2.1%CV |
| Serum Glucose (220mg/dL) | Low %CV for within-run and total imprecision | Within Run: 0.6%CV; Total: 1.1%CV |
| Serum Glucose (387mg/dL) | Low %CV for within-run and total imprecision | Within Run: 0.6%CV; Total: 1.3%CV |
| CSF Glucose (57mg/dL) | Low %CV for within-run and total imprecision | Within Run: 1.2%CV; Total: 2.4%CV |
| CSF Glucose (33mg/dL) | Low %CV for within-run and total imprecision | Within Run: 1.9%CV; Total: 4.1%CV |
| Urine Glucose (24mg/dL) | Low %CV for within-run and total imprecision | Within Run: 2.9%CV; Total: 5.8%CV |
| Urine Glucose (315mg/dL) | Low %CV for within-run and total imprecision | Within Run: 1.0%CV; Total: 1.6%CV |
| ORDAC Serum Glucose (557mg/dL) | Low %CV for within-run and total imprecision | Within Run: 1.5%CV; Total: 1.8%CV |
| ORDAC Serum Glucose (770mg/dL) | Low %CV for within-run and total imprecision | Within Run: 0.9%CV; Total: 1.5%CV |
| Linearity/Assay Reportable Range | Slope close to 1, Intercept close to 0, high R-squared | Slope: 1.012, Intercept: 0.1.97, R²: 1.000 |
| Normal Range (All Specimens) | Accurate detection within 5 to 450 mg/dL | 5 to 450 mg/dL (0.3 to 25 mmol/L) |
| ORDAC Range (All Specimens) | Accurate detection within 450 to 900 mg/dL | 450 to 900 mg/dL (25 to 50 mmol/L) |
| Sensitivity | Value <= 5.0 mg/dL | Observed: 0.255 mg/dL (claimed: 5.0 mg/dL) |
| Analytical Specificity | No adverse effect from interfering substances | Hemoglobin (up to 500 mg/dL), Bilirubin (up to 20 mg/dL), Lipemia (up to 1800 mg/dL) showed no adverse effect. |
| Patient Comparison | Strong correlation with predicate (slope close to 1, intercept close to 0, high R²) | Serum: Slope 1.011, Intercept -1.2, R² 0.999 Plasma: Slope 1.000, Intercept 1.0, R² 0.999 Urine: Slope 1.012, Intercept -2.1, R² 0.999 CSF: Slope 0.973, Intercept 1.0, R² 0.999 |
2. Sample Sizes Used for the Test Set and Data Provenance
- Precision/Reproducibility: Control sera and spiked urine pools were each assayed in triplicate, two times per day over 10 days. This means for each of the 9 samples (7 standard + 2 ORDAC), there were 60 individual measurements (3 tests/day * 2 times/day * 10 days).
- Linearity/Assay Reportable Range: Commercially available linearity standards were analyzed in triplicate. No specific number of standards or replicates beyond "triplicate" is given.
- Sensitivity: 21 replicates of a diluted serum control were performed.
- Analytical Specificity: Stock solutions of interfering substances were prepared and added to a 96 mg/dL glucose stock sample. No specific number of samples or replicates is mentioned beyond the description of the preparation of a test and control stock.
- Patient Comparison:
- Serum: 79 adult patient specimens
- Plasma: 80 adult patient specimens
- Urine: 81 adult patient specimens (spiked with glucose)
- CSF: 45 adult patient specimens
- Data Provenance: The document does not explicitly state the country of origin. The study appears to be prospective as it involves the collection and assaying of patient specimens and the generation of new experimental data on the device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There were no experts used to establish a ground truth for the test set in this study. The ground truth for comparative effectiveness and performance in this context is the measurement obtained from the predicate device (Beckman Glucose Reagent for the CX3) or established laboratory methods (e.g., for linearity standards, sensitivity).
4. Adjudication Method for the Test Set
No adjudication method was used for the test set. The study compares the performance of the new device to a predicate device and established laboratory guidelines for precision, linearity, and sensitivity. Discrepancies would be identified through statistical analysis (e.g., linear regression for patient comparison, %CV for precision) rather than expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study concerns the performance of an in vitro diagnostic reagent, not a system that involves human interpretation of images or other data typically associated with MRMC studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, this was a standalone study. The device (Glucose Oxidase Reagent) is a chemical reagent used on an automated analyzer (Beckman SYNCHRON CX3® System). Its performance is evaluated intrinsically through laboratory tests (precision, linearity, sensitivity, specificity) and comparison to a predicate reagent, without human intervention in the interpretation of the results themselves. The results are quantitative values.
7. The Type of Ground Truth Used
The ground truth used in this study is primarily based on:
- Reference Methods/Predicate Device: For patient comparison, the measurements from the predicate device (Beckman Glucose Reagent) on the same SYNCHRON CX3® System served as the reference.
- Established Analytical Standards: For linearity, commercially available linearity standards with known concentrations were used.
- Statistical Calculation: For sensitivity, the ground truth was derived from the statistical calculation of three standard deviations of a diluted serum control.
- Known Concentrations: For analytical specificity, interfering substances at specified concentrations were added to a stock sample with a known glucose level.
Essentially, the ground truth is derived from existing, validated analytical methods and materials.
8. The Sample Size for the Training Set
There is no mention of a "training set" in the context of this submission. The device is a chemical reagent, not a machine learning algorithm that requires a training phase.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there was no training set.
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