Search Results
Found 1 results
510(k) Data Aggregation
(70 days)
SYNCHRON CX SYSTEMS URIC ACID (URIC) REAGENT
The SYNCHRON Systems Uric Acid (URIC) Reagent, in conjunction with SYNCHRON MULTI™ Callbrator, is intended for use in the quantitative determination of uric acid in serum, plasma, and urine samples. This assay is designed for use with clinical chemistry analyzers from Beckman Instruments, such as the SYNCHRON CX® and LX™ Clinical Systems.
The SYNCHRON Systems Uric Acid (URIC) reagent is designed for use with clinical chemistry analyzers from Beckman Instruments, such as the SYNCHRON CX® and LXTM Clinical Systems When used in conjunction with SYNCHRON MULTI™ Calibrator, it is intended for use in the quantitative determination of uric acid concentration in serum, plasma, and unne samples. Measurements obtained by this device are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis. starvation or other wasting conditions, and of patients receiving cytotoxic drugs.
Here's a summary of the acceptance criteria and study details for the SYNCHRON® Systems Uric Acid (URIC) Reagent, based on the provided document:
1. Acceptance Criteria and Reported Device Performance
The device's performance was evaluated against a predicate device (Beckman SYNCHRON Uric Acid Reagent on the SYNCHRON CX System) to demonstrate substantial equivalence. The document doesn't explicitly state quantitative acceptance criteria thresholds but implies that performance values that are comparable to the predicate are acceptable.
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance (SYNCHRON LX System) |
|---|---|---|
| Method Comparison (Serum/Plasma) | Similar to predicate | Slope: 0.977, Intercept: -0.020 mg/dL, r: 0.9985 (n=79) |
| Method Comparison (Urine) | Similar to predicate | Slope: 0.995, Intercept: 0.116 mg/dL, r: 0.9990 (n=78) |
| Linearity (Serum - Default) | Linear across range | 0.5 - 12.0 mg/dL: linear |
| Linearity (Serum - ORDAC) | Linear across range | 9.0 - 21.0 mg/dL: linear (expanded range due to ORDAC) |
| Linearity (Urine) | Linear across range | 5.0 - 120 mg/dL: linear |
| Within-Run Imprecision (Level 1) | Low imprecision | Mean: 2.42 mg/dL, SD: 0.03 mg/dL, %C.V.: 1.1% (n=80) |
| Within-Run Imprecision (Level 2) | Low imprecision | Mean: 10.48 mg/dL, SD: 0.05 mg/dL, %C.V.: 0.5% (n=80) |
| Total Imprecision (Level 1) | Low imprecision | Mean: 2.42 mg/dL, SD: 0.05 mg/dL, %C.V.: 1.9% (n=80) |
| Total Imprecision (Level 2) | Low imprecision | Mean: 10.48 mg/dL, SD: 0.08 mg/dL, %C.V.: 0.8% (n=80) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size:
- Method Comparison (Serum/Plasma): 79 samples
- Method Comparison (Urine): 78 samples
- Imprecision (Within-Run & Total): 80 replicates per level (Level 1 and Level 2)
- Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. This device is a diagnostic reagent for quantitative measurement of uric acid, not an image analysis or interpretive device that requires expert review for ground truth. The "ground truth" in this context is the actual uric acid concentration as measured by the predicate device and the inherent chemical properties of the samples.
4. Adjudication Method for the Test Set
Not applicable. As noted above, this is a quantitative chemical assay, not an interpretive task requiring expert adjudication. The comparison is between the new device's readings and the predicate device's readings.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No. An MRMC comparative effectiveness study is designed for evaluating the performance of diagnostic tools that involve human interpretation (e.g., radiologists reading images). This document describes a chemical reagent; therefore, such a study would not be relevant.
6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, this entire study is a standalone performance evaluation of the SYNCHRON® Systems Uric Acid (URIC) Reagent on the SYNCHRON LX System. The performance metrics (method comparison, linearity, imprecision) directly reflect the device's analytical capabilities without human intervention in the measurement process itself, beyond operating the instrument.
7. The Type of Ground Truth Used
The ground truth for the performance studies was:
- Method Comparison: The measurements obtained from the Beckman SYNCHRON Uric Acid Reagent (URIC) on the SYNCHRON CX System (the predicate device) served as the reference for comparison.
- Linearity and Imprecision: The inherent chemical concentrations within the control samples and patient samples were the "ground truth." Linearity confirms the device's ability to accurately measure these concentrations across its claimed range, and imprecision evaluates the reproducibility of these measurements.
8. The Sample Size for the Training Set
Not applicable. This device is a chemical reagent and an associated analytical system. It is not an AI/ML device that requires a "training set" in the conventional sense. The performance characteristics described are based on analytical validation studies, not machine learning model training.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of this chemical reagent and analytical system.
Ask a specific question about this device
Page 1 of 1