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510(k) Data Aggregation
(100 days)
The "Wiener lab. Creatinina cinética AA" creatinine test system is a device intended to measure creatinine levels in human serum, plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as calculation basis for measuring other urine analytes.
The Creatinine assay is a clinical chemistry assay in which the creatinine in the sample, at an alkaline pH, reacts with picrate to form a creatinine-picrate complex. The rate of increase in absorbance at 500 nm due to the formation of this complex is directly proportional to the amount of creatinine in the sample
Here's a breakdown of the acceptance criteria and study information for the "Wiener lab. CREATININA CINETICA AA" test system, based on the provided text:
Important Note: This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices, not necessarily on presenting a full study report with detailed acceptance criteria and performance data for every characteristic. Therefore, some information, particularly regarding specific acceptance criteria thresholds for each performance metric, may not be explicitly stated as "acceptance criteria" but can be inferred from the comparison to the predicate devices. The study is a comparative effectiveness study against predicate devices. No information is available for training set.
1. Table of Acceptance Criteria (Inferred) and Reported Device Performance
For the "Wiener lab. CREATININA CINETICA AA" test system, acceptance criteria are implicitly tied to demonstrating performance that is equivalent to or better than the predicate devices ("RANDOX CREATININE" and "DMA CREATININE").
| Performance Metric | Acceptance Criteria (Inferred from Predicate) | Reported Device Performance (Wiener Lab.) |
|---|---|---|
| Intended Use | Quantitative determination of creatinine in human serum and plasma (RANDOX); Quantitative determination of creatinine in human serum and urine (DMA). | Quantitative determination of creatinine in human serum, plasma and urine. (Broader than RANDOX, matched with DMA) |
| Test Principle | The Creatinine assay is a clinical chemistry assay in which the creatinine in the sample, at an alkaline pH, reacts with picrate to form a creatinine-picrate complex. The rate of increase in absorbance at 500 nm due to the formation of this complex is directly proportional to the amount of creatinine in the sample. | The Creatinine assay is a clinical chemistry assay in which the creatinine in the sample, at an alkaline pH, reacts with picrate to form a creatinine-picrate complex. The rate of increase in absorbance at 500 nm due to the formation of this complex is directly proportional to the amount of creatinine in the sample. (Identical) |
| Essential Components | Picric acid and NaOH (RANDOX & DMA) | Picric acid and NaOH (Identical) |
| Reagents | RANDOX: R1: Picric acid/Surfactant, R2: NaOH; DMA: R2: Picric acid, R1: NaOH, sodium borate and surfactant. | R1: Picric acid, R2: Carbonate / NaOH. (Similar but with Carbonate in R2 for Wiener Lab.) |
| Preparation of Working Reagent | Mixture of R1 and R2 (1:1) (RANDOX & DMA) | Mixture of R1 and R2 (1:1) or they can be used separately. (More flexible) |
| Working Reagent Stability | RANDOX: Stable 3 days at 15-25°C in closed plastic bottle; DMA: Stable 14 days at 15-30°C in closed plastic bottle. | Stable 7 days at room temperature in closed plastic bottle and 24 hours on autoanalyzer. (Better than RANDOX, different from DMA with both longer room temp and autoanalyser stability) |
| Sample | Human serum and plasma (RANDOX); Human serum and urine (DMA). | Human serum, plasma and urine. (Broader than RANDOX, identical to DMA) |
| Working Temperatures | RANDOX: 25 - 30 - 37°C; DMA: 30 - 37°C. | 25 - 30 - 37°C (Matches RANDOX, broader than DMA) |
| Wavelength of Reading | 490-510 nm (RANDOX & DMA) | 490-510 nm (Identical) |
| Calibrator & Serum Controls | Available - provided separately (RANDOX & DMA) | Available - provided separately (Identical) |
| Linearity | RANDOX: 10 mg/dl; DMA: 20 mg/dl. | 20 mg/dl (Better than RANDOX, identical to DMA). |
| Minimum Detection Limit | RANDOX: Not specified; DMA: 0.06 mg/dl. | 0.012 mg/dl (Significantly better than DMA, and specified unlike RANDOX). |
| Expected Values (Serum) | RANDOX: Male: 0.6-1.1 mg/dl, Female: 0.5-0.9 mg/dl; DMA: 0.4-1.6 mg/dl. | 0.8-1.4 mg/dl. (Comparable ranges, within typical variations for healthy populations) |
| Expected Values (Urine) | RANDOX: N/A; DMA: 0.6-1.6 g/24hs. | 0.8-2.0 g/24hs. (Comparable range, slightly larger upper end) |
| Within-run Precision | RANDOX: No stated in insert; DMA: Normal Serum Control: CV = 2.9%, Abnormal Serum Control: CV = 1.3%. | Normal Serum Control: CV = 1.0%; Abnormal Serum Control: CV = 0.6%; Low Level Urine: CV = 0.4%; High Level Urine: CV = 0.5%. (Significantly better CV than DMA; specified when RANDOX was not). |
| Total Precision | RANDOX: No stated in insert; DMA: Normal Serum Control: CV = 4.2%, Abnormal Serum Control: CV = 1.7%. | Normal Serum Control: CV = 1.7%; Abnormal Serum Control: CV = 1.0%; Low Level Urine: CV = 0.7%; High Level Urine: CV = 1.1%. (Significantly better CV than DMA; specified when RANDOX was not). |
Summary of Device Performance vs. Predicates:
The Wiener lab. Creatinina Cinetica AA test system generally meets or exceeds the performance characteristics of its predicate devices, especially in areas like linearity, minimum detection limit, and precision (which are more quantitative metrics with direct comparison available). The "Conclusion" section explicitly states that the "Above mentioned data show substantial equivalency to the predicate devices."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for the Test Set: Not explicitly stated. The document presents comparative performance data (e.g., precision, linearity, detection limits, expected values) but does not detail the number of individual patient samples or control runs used to generate this data. It only lists performance metrics.
- Data Provenance: Not explicitly stated. The submitter is Wiener Laboratorios S.A.I.C. based in Rosario, Argentina. It is not specified whether the data for the performance characteristics was generated in Argentina or elsewhere, nor whether it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts & Qualifications: Not applicable. This device is a clinical chemistry assay, not an imaging or diagnostic device requiring expert interpretation for ground truth. The "ground truth" for such assays typically comes from established reference methods, spiked samples, or certified control materials with known concentrations. The document does not describe the methodology for establishing ground truth for the performance studies, other than implying the use of controls and calibrators.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. As a quantitative clinical chemistry assay, adjudication by multiple human readers is not relevant. Performance is measured against analytical standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices where human readers interpret results, and the AI's impact on their performance is being evaluated. This document concerns a chemical assay, not an interpretive diagnostic.
- Effect Size: Not applicable.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
- Standalone Study: Yes, in essence, the reported performance characteristics (linearity, detection limit, precision, etc.) represent the standalone performance of the assay system itself. There is no "human-in-the-loop" component in the direct operation or result generation of a creatinine assay; the system provides a direct quantitative measurement.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth for evaluating the performance metrics of a quantitative chemical assay like creatinine typically involves:
- Reference Standards/Calibrators: Solutions with precisely known concentrations of creatinine.
- Quality Control Materials: Commercial controls with established target ranges (e.g., normal serum control, abnormal serum control, urine controls).
- Spiked Samples: Patient samples to which a known amount of analyte has been added to test recovery and linearity.
- Comparison to Reference Methods: While not explicitly detailed as the "ground truth" for all metrics, the comparison to predicate devices implies that the performance is benchmarked against established, legally marketed systems.
The document does not detail the specific ground truth methods for each reported metric, but these are the standard approaches for such devices.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable/Not provided. This is a chemical assay, not a machine learning or AI-driven algorithm that requires a "training set" in the typical sense. Its performance is based on the chemical reactions and spectrophotometric measurements. The formulation of reagents and optimization of the method would be part of product development, but not an AI-style "training set."
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable. As mentioned above, there is no "training set" in the AI/machine learning context for this device.
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