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510(k) Data Aggregation
(161 days)
The Optilite C-Reactive Protein Reagent is intended for the quantitative in vitro determination of C-reactive protein (CRP) concentration in serum using the Binding Site Optilite analyser. Measurement of C-Reactive Protein aids in evaluation of the amount of injurv to body tissues and for evaluation of infection, tissue injurv, and inflammatory disorders. This test should be used in conjunction with other laboratory and clinical findings.
The Optilite C-Reactive Protein Calibrator is intended for the calibration of the Optilite C-Reactive Protein Reagent on the Optilite analyser.
The Optilite C-Reactive Protein Controls are intended for use in quality control by monitoring accuracy and precision for the Optilite C-Reactive Protein Reagent.
The Optilite C-Reactive Protein Reagent is comprised of a dual wedge containing the following:
Antiserum: Supplied in stabilised liquid form. Preservatives: 0.099% sodium azide, TRIS pH 8.0.
Reaction Buffer: Containing 0.099% sodium azide, TRIS pH 7.5 as preservatives.
The Optilite C-Reactive Protein Calibrator is comprised of the following: Pooled human serum, supplied in stabilised liquid form. Containing 0.099% sodium azide, as preservative.
The Optilite C-Reactive Protein Controls are comprised of the following: Pooled human serum, supplied in stabilised liquid form. Containing 0.099% sodium azide, as preservative.
The Binding Site Optilite C-Reactive Protein Reagent, Calibrator, and Controls have several performance characteristics, and the report details the studies conducted to verify these characteristics against pre-defined acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Precision/Reproducibility | Total precision (%CV < 10%), Within-run precision (%CV < 5%), Between-run precision (%CV < 8%), Between-day precision (%CV < 8%) | Sample 1 (6.8 mg/L): Total %CV 6.2, Within-run %CV 2.7, Between-run %CV 1.4, Between-day %CV 5.4, Between-batch %CV 0.6, Between-instrument %CV 3.0 Sample 2 (9.5 mg/L): Total %CV 4.3, Within-run %CV 1.2, Between-run %CV 1.3, Between-day %CV 3.9, Between-batch %CV 1.9, Between-instrument %CV 0.7 Sample 3 (21.5 mg/L): Total %CV 2.6, Within-run %CV 1.0, Between-run %CV 0.8, Between-day %CV 2.2, Between-batch %CV 2.6, Between-instrument %CV 0.8 Sample 4 (65.4 mg/L): Total %CV 3.1, Within-run %CV 0.7, Between-run %CV 0.8, Between-day %CV 2.9, Between-batch %CV 2.9, Between-instrument %CV 2.5 All reported values meet the acceptance criteria. |
| Linearity/Assay Reportable Range | %CV for each sample ≤ 8%, Allowable nonlinearity: 0.5mg/L up to 5mg/L, and ± 10% above 5mg/L (Visual inspection confirms all results within acceptable %CV for the provided data). | The reported %CV values for 14 samples ranging from 2.70 mg/L to 316.03 mg/L are all below 8% (ranging from 0.1% to 3.7%). The study states "Results met the Acceptance criteria for CV<8%." |
| Detection Limit (Limit of Quantitation - LoQ) | Not explicitly stated as an "acceptance criteria" but 5.0 mg/L is presented as the determined LoQ. | LoB = 1.35 mg/L, LoD = 2.66 mg/L, LoQ = 5.0 mg/L. |
| Analytical Specificity (Interference) | Mean results from spiked samples must be within 10% of the mean of the control samples. | The assay was not affected by: - Haemoglobin (5g/L) - Bilirubin (200mg/L) - Triglyceride (500mg/dL) - Intralipid (250mg/dL) - Rheumatoid Factor (2417IU/mL) - 14 therapeutic drugs at specified concentrations. All reported findings indicate the acceptance criteria for non-interference were met. |
| Method Comparison with Predicate Device (Clinical Concordance) | Not explicitly stated as a numerical acceptance criterion, but the intention is to demonstrate strong agreement. | 98.4% of samples tested gave clinically concordant results on both analysers (Optilite and predicate). Regression statistics (Weighted Linear, Passing-Bablok, Weighted Deming) also show good correlation. |
2. Sample size used for the test set and the data provenance:
- Precision/Reproducibility: 4 sera samples. The provenance is not specified (e.g., country of origin or retrospective/prospective).
- Linearity/Assay Reportable Range: A series of 14 samples. The provenance is not specified.
- Detection Limit: LoB and LoD were based on 4 serum samples, while LoQ was determined from 4 serum samples. The provenance is not specified.
- Analytical Specificity (Interference): Serum samples with CRP concentrations at approximately 9mg/L, 60mg/L, and 150mg/L. The provenance is not specified.
- Method Comparison: 193 serum samples, including 83 normal donors and 110 clinical samples. The provenance is not specified.
- Expected values/Reference range verification: 50 adult donor samples. The provenance is not specified.
All studies appear to be prospective in nature, as they involve testing the device under controlled conditions to determine its performance characteristics.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This device is an in vitro diagnostic (IVD) assay for measuring C-Reactive Protein concentration. Ground truth is established by the analytical method itself (e.g., precise dilution, reference methods, or spiking with known quantities) rather than expert interpretation of images or clinical data. Therefore, experts in human diagnosis are not directly involved in establishing the ground truth for these analytical performance studies. The studies followed established CLSI guidelines for laboratory assay validation.
4. Adjudication method for the test set:
Not applicable. As described above, the studies focus on analytical performance where ground truth is intrinsically known or established through controlled experimental design and reference methods, not through expert adjudication of results.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is an IVD device for quantitative measurement of a biomarker (CRP). It does not involve human readers interpreting images or clinical cases, nor does it incorporate AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, the studies described are standalone performance evaluations of the analytical device (Optilite CRP Reagent, Calibrator, Controls) on the Optilite analyser. The performance metrics (precision, linearity, detection limit, specificity) are inherently algorithm-only or instrument-only performance measures, as the human involvement is in operating the instrument and interpreting the numerical output, not in making a diagnostic interpretation that the instrument assists.
7. The type of ground truth used:
- Precision/Reproducibility: The "ground truth" for precision studies are the known concentrations of the sera samples, which are then measured repeatedly to assess variability.
- Linearity/Assay Reportable Range: The "ground truth" is the known concentration gradient created by mixing high and low concentration pools, or by spiking with pure protein, allowing for comparison with the measured values.
- Detection Limit: The "ground truth" is based on statistical calculations from repeated measurements of blank and low-concentration samples.
- Analytical Specificity: The "ground truth" involves comparing results from samples with known interfering substances added to those without, to assess if the interfering substances impact expected CRP values.
- Method Comparison: The "ground truth" is the result obtained from the legally marketed predicate device (Roche Diagnostics Tina-Quant C-Reactive Protein Gen. 3) when assaying the same samples.
- Traceability: The assay calibration is traceable to the international reference standard ERM-DA474, which serves as the "ground truth" for CRP concentration.
8. The sample size for the training set:
Not applicable. This is not a machine learning or AI-driven device that requires a distinct training set. The calibration curve is established using known calibrator materials according to standard IVD practices, not a machine learning training process.
9. How the ground truth for the training set was established:
Not applicable, as there is no machine learning training set. For the instrument's calibration, the Optilite C-Reactive Protein Calibrator is used. This calibrator consists of pooled human serum, and its concentrations are traceable to the international reference standard ERM-DA474. This traceability ensures that the instrument's measurements relate to a globally recognized standard for CRP.
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