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510(k) Data Aggregation
(260 days)
The C-Reactive Protein Kit for use on SPAPLUS is intended for the quantitative in vitro determination of C-reactive protein (CRP) concentration in serum. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues and for evaluation of infection, tissue injury, and inflammatory disorders. This product is suitable for use on the SPAPLUS analyser.
The C-Reactive Protein Kit for use on SPAPLUS is comprised of the following reagents:
Antiserum: Supplied in stabilised liquid form. Preservatives: 0.099% sodium azide, TRIS pH 8.0.
Calibrator and Controls: Pooled human serum, supplied in stabilised liquid form. Containing 0.099% sodium azide, as preservative. The concentration given on the quality control certificate has been obtained by comparison with the international reference standard ERM-DA474.
Reaction Buffer: Containing 0.099% sodium azide, TRIS pH 7.5 as preservatives.
The provided document is a 510(k) premarket notification for a C-Reactive Protein Kit for use on the SPAPLUS analyzer. It details the device's intended use, comparison to a predicate device, and performance characteristics.
Here’s a breakdown of the acceptance criteria and the study that proves the device meets those criteria, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Precision/Reproducibility | ||
| Total precision | %CV < 10% | All samples met: Sample 1 (8.4%), Sample 2 (7.1%), Sample 3 (2.5%), Sample 4 (1.8%) |
| Within-run precision | %CV < 5% | All samples met: Sample 1 (1.9%), Sample 2 (1.3%), Sample 3 (0.6%), Sample 4 (0.5%) |
| Between-run precision | %CV < 8% | All samples met: Sample 1 (4.5%), Sample 2 (3.8%), Sample 3 (1.9%), Sample 4 (1.8%) |
| Between-day precision | %CV < 8% | All samples met: Sample 1 (6.9%), Sample 2 (5.8%), Sample 3 (1.5%), Sample 4 (0.0%) |
| Linearity/Assay Reportable Range | ||
| %CV for each sample | ≤8% | All samples met (highest %CV was 1.9%) |
| Allowable nonlinearity | ± 10% (Implicitly met as no issues were reported and linearity was "assessed across the curve width at the standard sample dilution (1/1)") | Results met Acceptance criteria for CV<8%. (Nonlinearity explicitly stated as met) |
| Analytical Specificity (Interference Testing) | ||
| Non-interference claim | Mean results from spiked samples must be within 10% of the mean of control samples | Assay not affected by: Haemoglobin (5g/L), Bilirubin (200mg/L), Rheumatoid Factor (2417IU/mL), Intralipid (250mg/dL), and 14 therapeutic drugs. |
| Method Comparison with Predicate Device | Clinically concordant results (No specific numeric acceptance criteria for regression statistics provided, but clinical concordance is key) | 99.6% of samples tested gave clinically concordant results. |
2. Sample Sizes and Data Provenance
- Precision/Reproducibility: 4 serum samples were tested. The study design followed CLSI EP5-A2, with 2 runs per day (each in duplicate) over 21 days.
- Linearity/Assay Reportable Range: A series of 13 samples was tested in 3 replicates.
- Detection Limit: LoB was based on 60 determinations of a blank sample. LoQ study was carried out on two reagent lots.
- Analytical Specificity: Serum samples with targeted CRP concentrations (elevated ~60 mg/L and near reference interval ~5 mg/L) were spiked with interfering substances and tested in replicates of 3.
- Method Comparison with Predicate Device: A total of 225 serum samples were assayed.
- Data Provenance: The document does not explicitly state the country of origin for the samples. It mentions "normal donors" and "clinical samples" for the method comparison study, implying that the data is from relevant patient populations, but does not specify if it was retrospective or prospective. Given the nature of an in vitro diagnostic device for laboratory testing, the samples are collected from individuals and then analyzed in a lab setting.
3. Number of Experts and Qualifications for Ground Truth for Test Set
The document does not describe the use of human experts to establish ground truth for the test set in the conventional sense of, for example, image interpretation by radiologists. This device is an in vitro diagnostic (IVD) test, where the "ground truth" for method comparison and performance evaluation is typically established by:
- Reference Methods/Predicate Devices: The predicate device itself (Roche Diagnostics Tina-Quant C-Reactive Protein Gen. 3) serves as a comparative "gold standard" or established method for evaluating if the new device produces similar results.
- International Reference Standards: The calibration of the CRP assay is traceable to the international reference standard ERM-DA474, which ensures accuracy against a widely recognized reference material.
Therefore, the concept of "number of experts" and their qualifications as typically applied to, for instance, image analysis, is not directly applicable here.
4. Adjudication Method for the Test Set
Not applicable. As described above, the "ground truth" is based on reference methods, predicate device comparison, and international standards, not subjective expert assessment requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This is an in vitro diagnostic device, not a device requiring human reader interpretation (e.g., medical imaging AI). Therefore, an MRMC study is not relevant or applicable. The AI/human-in-the-loop concept does not apply to this type of device.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)
Yes, the studies presented (Precision, Linearity, Detection Limit, Analytical Specificity) are all standalone performance evaluations of the device (C-Reactive Protein Kit for use on SPAPLUS) itself. The in vitro diagnostic device is an automated system run on an analyzer (SPAPLUS), and its performance is evaluated in isolation from human interpretation beyond routine laboratory operation and quality control. The method comparison study also evaluates the device's analytical performance against a predicate.
7. Type of Ground Truth Used
- Reference Methods/Predicate Device: For the method comparison study, the results from the legally marketed predicate device (Roche Diagnostics Tina-Quant C-Reactive Protein Gen. 3) served as the comparative data point.
- International Reference Standards: The calibration of the new device is traceable to the international reference standard ERM-DA474, which provides the ultimate analytical ground truth for CRP concentration.
- Spiked Samples/Known Concentrations: For studies like linearity, detection limit, and analytical specificity (interference), samples with known or spiked concentrations of CRP and interfering substances are used to evaluate the device's accuracy and resistance to interference.
8. Sample Size for the Training Set
Not applicable. This document describes an in vitro diagnostic device that is based on immunoturbidimetry, a chemical reaction and measurement process. It's not an AI/Machine Learning device that requires a "training set" in the computational sense. The "training" here refers to the calibration of the instrument using calibrator material traceable to reference standards.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the AI/ML sense. For the calibration (which could be conceptually similar to "training" in an analytical device context):
- Calibrators traceable to ERM-DA474: The calibrators included in the kit are pooled human serum with concentrations established by comparison with the international reference standard ERM-DA474. This established value serves as the ground truth for the calibration process, ensuring accuracy across measurements.
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