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510(k) Data Aggregation
(126 days)
SEALITE SCIENCES, INC. AQUALITE FERRITIN ASSAY
The AquaLite® Ferritin Bioluminescent Immunoassay (BIA) Kit (or the AquaLite® Ferritin Assay) is an in vitro diagnostic product intended for use in clinical laboratories for the quantitative determination of human ferritin in serum and plasma. Ferritin measurements are used in the diagnosis of diseases affecting iron metabolism.
The AquaLite® Ferritin Bioluminescent Immunoassay Kit uses a mouse monoclonal antiferritin antibody that is pre-coated onto polystyrene tubes (solid phase). Samples (serum or plasma), or appropriate calibrators or controls, are pipetted (25 uL) into the precoated tubes. A mouse monoclonal anti-ferritin antibody covalently linked to AquaLite® (150 uL) is then added to the tubes. Ferritin in the sample simultaneously combines with the antibody on the solid phase and conjugate antibody to form an immune complex or "sandwich" bound to the solid phase. Complex formation is complete after a 60-minute incubation period at room temperature on a standard orbital shaker. The tubes are then washed to remove unbound conjugate.
The washed tubes are placed in a luminometer that is capable of reading a triggered, flash-type reaction in 12 x 75 mm tubes. Injection of the calcium trigger buffer causes AquaLite® to oxide its self-contained luciferin molecule, producing a flash of light, which is measured by the luminometer. The intensity of the light emitted from antibody bound to the tubes is directly proportional to the concentration of the ferritin in the sample. To calculate results, the light intensity (in relative light units, RLU) of the ferritin calibrators is plotted against ferritin concentration (in ng per mL) to yield a calibration curve. This curve is used to relate the light intensity generated from the samples and controls to ferritin concentration in ng/mL.
Note: Samples that generate signals greater than the signal from the highest calibrator are off-scale. These samples must be diluted and re-assayed. Remember to multiply the results from diluted samples by the dilution factor used.
The provided document describes the SeaLite Sciences, Inc. AquaLite® Ferritin Assay, a bioluminescent immunoassay for the quantitative determination of human ferritin in serum and plasma.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance | Comments |
|---|---|---|---|
| Sensitivity | Not explicitly stated (e.g., lower limit of detection based on clinical need) | 0.03 ng/mL | Determined by adding the mean signal of 20 replicates of the zero-level calibrator + 2 standard deviations. |
| Specificity (Cross-Reactivity) | Not explicitly stated (e.g., % cross-reactivity with structurally similar molecules within a certain range). | 85% and 103% for spiked liver ferritin in two human serum samples. | Measures "intact ferritin." The values indicate good consistency in measuring spiked ferritin. |
| High Dose Hook Effect | No hook effect within a clinically relevant range. | No high dose hook effect occurs prior to 10,000 ng/mL. | This is an important safety and accuracy measure for immunoassays. |
| Intra-assay Precision (CV) | Not explicitly stated (e.g., 0.95 and slope close to 1, y-intercept close to 0). | Correlation coefficient (R) = 0.98 | |
| Slope = 0.72 | |||
| Y-intercept = 15.9 | Indicates strong correlation with the predicate device (Chiron Diagnostics ACS:180 Ferritin Assay), though the slope suggests a slight systemic difference. | ||
| Linearity and Nonparallelism (Recovery) | Not explicitly stated (e.g., recovery within 80-120%). | Sample A: 96.6-119.5% | |
| Sample B: 109.5-121.9% | |||
| Sample C: 86.4-92.3% | Generally good recovery across dilutions, demonstrating linearity. | ||
| Spike and Recovery | Not explicitly stated (e.g., recovery within 80-120%). | Sample 1: 86% | |
| Sample 2: 100% | |||
| Sample 3: 84% | Good recovery of spiked ferritin, showing the assay can accurately measure ferritin اضافه. | ||
| Recovery in Serum and Plasma | Not explicitly stated (e.g., differences within a certain percentage, demonstrating matrix equivalence). | % Recovery in EDTA plasma vs. Serum: 85-103% | Demonstrates the assay performs similarly in both serum and EDTA plasma. |
| Effect of Common Interferents (Recovery) | Not explicitly stated (e.g., recovery within 90-110% in the presence of interferents). | Hemoglobin (500mg/dL): 98% | |
| Bilirubin (20mg/dL): 90% | |||
| Triglycerides (3000mg/dL): 99% | Shows the assay is not significantly affected by these common interferents within the tested concentrations. |
2. Sample Sizes and Data Provenance
- Test Set Sample Sizes:
- Sensitivity: 20 replicates of a zero-level calibrator.
- Specificity: 2 human serum samples (spiked).
- Precision (Intra-assay): N = 20 per concentration level for commercial controls.
- Precision (Inter-assay): N = 20 (2 replicates x 10 assays) for commercial controls.
- Method Comparison: N = 99 patient samples.
- Linearity: 3 human serum samples, each diluted.
- Spike and Recovery: 3 normal human serum samples.
- Recovery in Serum and Plasma: 6 normal subjects.
- Effect of Common Interferents: Pooled normal human serum (spiked).
- Data Provenance: The studies were conducted at SeaLite Sciences. All samples appear to be human (serum, plasma, human spleen ferritin for spiking). The document does not specify the country of origin for the human samples. The studies are by nature prospective for the device's validation, as they were specifically designed and executed to evaluate the AquaLite® Ferritin Assay.
3. Number of Experts and Qualifications for Ground Truth
This device is an in vitro diagnostic (IVD) assay for quantitative measurement. The "ground truth" is typically established instrumentally or by reference methods/materials rather than expert consensus on images or clinical assessments.
- No "experts" in the sense of clinical reviewers (e.g., radiologists) were used to establish ground truth.
- The "ground truth" for quantitative assays like this relies on:
- Reference materials: Commercial controls with known ferritin concentrations, calibrators traceable to international standards (e.g., WHO 2nd IS 80/578 for spike and recovery).
- Predicate device: The Chiron Diagnostics ACS:180 Ferritin Assay served as a reference for method comparison.
4. Adjudication Method for the Test Set
Not applicable. As a quantitative IVD assay, adjudication by multiple human readers (as in image-based diagnostic aids) is not relevant. The results are numerical measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. Such studies are typically performed for diagnostic imaging devices or AI-powered clinical decision support tools where human interpretation plays a significant role. This document describes an automated laboratory assay.
6. Standalone Performance
Yes, the studies listed (Sensitivity, Specificity, Precision, High Dose Hook Effect, Linearity, Spike and Recovery, Recovery in Serum and Plasma, Effect of Common Interferents) describe the standalone performance of the AquaLite® Ferritin Assay. These evaluations assess the algorithm (the assay's chemical/biological reaction and measurement system) without human interpretation in the results generation process itself. The "Method Comparison" also shows the standalone performance relative to an existing predicate device.
7. Type of Ground Truth Used
The ground truth used is primarily based on:
- Known concentrations: From commercial controls, calibrators, and spiked samples.
- Reference methods/materials: Comparison against a legally marketed predicate device (Chiron Diagnostics ACS:180 Ferritin Assay) and internationally recognized standards (WHO 2nd IS 80/578 for spleen ferritin).
8. Sample Size for the Training Set
The document does not specify a separate "training set" sample size. For an immunoassay like this, the "training" typically refers to the development and optimization of the assay's reagents and parameters, which is an iterative process often involving experimental work rather than a distinct, labeled "training set" of patient data as seen in machine learning contexts. The calibrators and controls used would be part of the ongoing validation and quality control, but not a separate "training set" for an algorithm in the modern sense.
9. How the Ground Truth for the Training Set Was Established
Not explicitly stated in terms of a formal "training set ground truth." However, the equivalent process for an immunoassay involves:
- Development and Optimization: During the development phase, reagents, incubation times, concentrations, and detection methods are optimized using known ferritin concentrations (potentially from purified ferritin, spiked samples, or commercial controls) to achieve desired performance characteristics.
- Calibrators: The assay uses calibrators with established ferritin concentrations to generate its standard curve. These calibrators are usually traceable to primary reference materials.
- Quality Control (QC) Materials: Commercial QC materials with defined ferritin values are used to monitor assay performance over time.
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