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510(k) Data Aggregation
(366 days)
ELITech Clinical Systems CREATININE PAP SL is intended for the quantitative in vitro diagnostic determination of creatinine in human serum and plasma on Vital Scientific Selectra/Flexor analyzers. It is not intended for use in Point of Care settings. Creatinine measurements are used in the diagnosis and treatment of renal diseases, and in monitoring renal dialysis.
The device for this submission is available as kit only. It consists of 2 reagents, "R1" and "R2". Reagent R1 contains: MOPS buffer (pH 7.50), EHSPT (N-Ethyl-N-2(-Hydroxy-3-Sulfopropyl)- m -Toluidine), Creatinase (microoganism), Sarcosine oxidase (microoganism), Ascorbate oxidase (vegetal). Reagent R2 contains: MOPS buffer (pH 7.50), Amino-4-antipyrine (4-AAP), Creatininase (bacterial), Peroxidase (horseradish), and Sodium azide.
The provided text describes the ELITech Clinical Systems CREATININE PAP SL device, its calibrator (ELICAL 2), and controls (ELITROL I and ELITROL II). It details their intended use, composition, and performance characteristics, comparing them to predicate devices. The document essentially serves as a summary for a 510(k) premarket notification to the FDA, demonstrating substantial equivalence.
Here's an analysis of the acceptance criteria and the studies that prove the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a separate section with pass/fail thresholds. Instead, it presents performance data for the ELITech Clinical Systems CREATININE PAP SL and compares it directly to a predicate device (Roche Diagnostics Creatinine plus ver.2). The implication is that performance comparable to or better than the predicate device satisfies the acceptance criteria for substantial equivalence.
Here's a table summarizing the performance metrics and their comparison to the predicate device:
| Performance Characteristic | ELITech Clinical Systems CREATININE PAP SL (Reported Performance) | Predicate Device (Roche Diagnostics Creatinine plus ver.2) | Implied Acceptance Criteria (Demonstrates Substantial Equivalence) |
|---|---|---|---|
| Measuring Range | 0.28 - 22.30 mg/dL | 0.06 - 30.5 mg/dL | Range should cover clinically relevant levels and be comparable to predicate. (ELITech's range is narrower on both ends than the predicate). |
| Limit of Detection (LoD) | 0.006 mg/dL | Serum/plasma: 0.06 mg/dL | LoD should be sufficiently low for clinical utility and comparable to predicate. (ELITech's LoD is lower/better than the predicate for serum/plasma). |
| Limit of Quantification (LoQ) | 0.28 mg/dL | Not explicitly stated for LoQ, but LoD provides a lower bound. | LoQ should be clinically acceptable. (Compared to predicate's LoD, ELITech's LoQ is higher, but this is a different metric). |
| Precision (Within Run) | Level 0.59 mg/dL: CV=1.3%Level 1.62 mg/dL: CV=0.8%Level 6.93 mg/dL: CV=1.4% | Level 0.97 mg/dL: CV=2.29%Level 3.95 mg/dL: CV=1.16%Level 0.77 mg/dL: CV=2.86%Level 12.7 mg/dL: CV=1.26% | Coefficient of Variation (CV) should indicate acceptable reproducibility and be comparable to predicate. (ELITech's within-run CVs generally appear better at comparable levels). |
| Precision (Total) | Level 0.59 mg/dL: CV=3.2%Level 1.62 mg/dL: CV=1.6%Level 6.93 mg/dL: CV=2.8% | Level 0.97 mg/dL: CV=2.35%Level 3.95 mg/dL: CV=0.91%Level 0.75 mg/dL: CV=1.87%Level 13.2 mg/dL: CV=0.60% | CV should indicate acceptable reproducibility over time and be comparable to predicate. (ELITech's total CVs are mixed; some better, some worse than predicate at comparable levels). |
| Method Comparison (Regression) | y = 1.045x - 0.01 mg/dLr = 0.999Range: 0.30 to 20.30 mg/dL | y = 1.006x - 0.013 mg/dLr = 0.9998Range: 0.52 to 18.9 mg/dL | Regression analysis (slope, intercept, correlation coefficient) should demonstrate strong agreement with the predicate method. (Both devices show excellent correlation (r close to 1) and similar regression equations). |
| Interferences (Limitations) | Hemoglobin: No interference up to 500 mg/dL.Triglycerides: No interference up to 3198 mg/dL.Unconjugated bilirubin: No interference up to 30.0 mg/dL.Conjugated bilirubin: No interference up to 14.8 mg/dL.Uric acid: No interference up to 24 mg/dL.Glucose: No interference up to 550 mg/dL.Ascorbic acid: No interference up to 20 mg/dL.Methyl-dopa, L-dopa, Calcium dobesilate: Falsely low results at therapeutic conc.Creatine: Positive bias from 5 mg/dL. | Hemoglobin: No interference up to 800 mg/dL.Lipemia (Intralipid): No influence up to L index of 1000.Icterus: No influence up to I Index of 20 (20 mg/dL bilirubin).Ascorbic acid: < 300 mg/L (30 mg/dL) does not interfere.Drugs: No interference with common drug panels.Exceptions: Levodopa and calcium dobesilate cause artificially low creatinine levels.Other: Monoclonal gammopathy can lead to incorrect results.Creatine: No significant interference up to 20 mg/dL. | Interference profile should be understood and comparable or better, with identified limitations. (ELITech shows similar interference patterns for some substances, but different thresholds for others, and similar specific drug interferences. Creatine interference is noted at a lower level for ELITech). |
| Calibration Frequency | 14 days | Each lot and as required | Clinically acceptable calibration stability. (ELITech's 14-day calibration is a defined period). |
| On-board Stability | 28 days (refrigerated area) | 4 weeks (refrigerated area) | Stability should be sufficient for practical lab use. (Comparable at 28 days vs 4 weeks). |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: The document does not explicitly state the sample sizes used for each performance study (e.g., precision, method comparison). For method comparison, it mentions a range of 0.30 to 20.30 mg/dL, implying multiple samples across this range were tested, but no specific number of samples (N) is given.
- Data Provenance: Not specified. The document does not indicate the country of origin of the data or whether the studies were retrospective or prospective. It only states the submitter is SEPPIM S.A.S. from France.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts:
- Number of Experts/Qualifications: Not applicable for this type of in vitro diagnostic device (IVD). For IVDs like creatinine assays, "ground truth" is typically established by reference methods or validated comparative methods, not by human expert interpretation of images or other subjective data. The predicate device itself (Roche Diagnostics Creatinine plus ver.2) serves as the primary "ground truth" for method comparison, which is a common approach for demonstrating substantial equivalence for clinical chemistry assays.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. As described above, this is an IVD assay where performance is determined by analytical measurements against established methods, not by expert adjudication of subjective results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- MRMC Study: No. MRMC studies are typically used for medical imaging devices where human readers interpret results. This is a clinical chemistry assay, so an MRMC study is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Yes, implicitly. The performance data presented (measuring range, LoD, LoQ, precision, method comparison, limitations) are for the device (reagent and instrument) operating in a standalone analytical capacity, without direct human cognitive interpretation or intervention required for each result once the assay is set up. The performance metrics reflect the algorithm's (assay's) ability to quantify creatinine directly.
7. The Type of Ground Truth Used:
- Ground Truth Type:
- Method Comparison: The predicate device itself (Roche Diagnostics Creatinine plus ver.2) serves as the "ground truth" or reference for comparison in the method comparison study. The agreement (regression analysis) between the new device and the predicate is the primary evidence of performance.
- Analytical Performance: For parameters like LoD, LoQ, and precision, the "ground truth" is derived from established analytical methods and statistical calculations following laboratory guidelines for assay validation. While not explicitly stated, this would typically involve using known concentration samples or highly characterized materials.
8. The Sample Size for the Training Set:
- Training Set Sample Size: Not applicable. This document is for an IVD reagent system, not a machine learning or AI model that requires a distinct "training set" for development in the typical sense. The assay chemistry and instrument parameters are developed through conventional analytical chemistry and engineering processes.
9. How the Ground Truth for the Training Set was Established:
- Training Set Ground Truth: Not applicable for the reasons stated above. The development of the assay chemistry involves extensive R&D and optimization, but not a "training set" with ground truth in the context of AI/ML.
In Conclusion:
The ELITech Clinical Systems CREATININE PAP SL's acceptance criteria are implicitly defined by the analytical performance of its legally marketed predicate device. The study demonstrates that the new device exhibits comparable analytical performance across various metrics (precision, method comparison, detection limits, and interference profiles), thereby meeting the requirements for substantial equivalence. The studies conducted are typical analytical validation studies for IVD assays, focusing on the device's standalone performance in quantifying creatinine.
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