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510(k) Data Aggregation
(138 days)
The EDIA™ anti-CCP test kit is an enzyme-linked immunosorbent assay (ELISA) for detection and semi-quantitation of IgG antibodies to Cyclic Citrullinated Peptides (CCP) in human sera and plasma. The assay is used to detect antibodies in a single specimen. The results of the assay are to be used as an aid to the diagnosis of Rheumatoid Arthritis (RA), in conjunction with other laboratory and clinical findings. The analysis should be performed by trained laboratory professionals.
The EDIA™ anti-CCP test kit is an enzyme-linked immunosorbent assay (ELISA) for detection and semi-quantitation of IgG antibodies to Cyclic Citrullinated Peptides (CCP) in human sera and plasma. The assay is used to detect antibodies in a single specimen. The results of the assay are to be used as an aid to the diagnosis of Rheumatoid Arthritis (RA), in conjunction with other laboratory and clinical findings. Trained laboratory professionals should perform the analysis. "For in vitro diagnostic use".
The wells are coated with Cyclic Citrullinated Peptides. During the first incubation, specific antibodies in diluted serum, will bind to the antigen coating.
The wells are then washed to remove unbound antibodies and other components. A conjugate of alkaline phosphatase labelled antibodies to human IgG binds to the antibodies in the wells in this second incubation.
After a further washing step, detection of specific antibodies is obtained by incubation with substrate solution. The amount of bound antibodies correlates to the colour intensity and is measured in terms of absorbance (optical density (OD)). The absorbance is then calculated against a calibrator curve and the results are given in arbitrary units.
Here's a breakdown of the acceptance criteria and study details for the EDIA™ anti-CCP kit, based on the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are not explicitly stated as strict pass/fail thresholds in the provided document. Instead, the study aims to demonstrate substantial equivalence to a predicate device and establish clinical performance characteristics. The reported device performance is as follows:
| Performance Metric | Acceptance Criteria (Implied / Predicate Comparison) | Reported Device Performance |
|---|---|---|
| Predicate Device Comparison | ||
| Positive Percent Agreement | Substantial equivalence to Immunoscan RA anti-CCP (e.g., high agreement). | 98.4% (95% CI: 96.4 - 99.5%) |
| Negative Percent Agreement | Substantial equivalence to Immunoscan RA anti-CCP (e.g., high agreement). | 99.4% (95% CI: 98.0 - 99.9%) |
| Overall Percent Agreement | Substantial equivalence to Immunoscan RA anti-CCP (e.g., high agreement). | 99.0% (95% CI: 97.9 - 99.6%) |
| Linear Correlation (EDIA vs. Immunoscan RA) | Strong positive linear correlation expected. | R-squared = 0.8886 |
| Clinical Performance | ||
| Clinical Sensitivity (RA patients) | Adequate sensitivity for aiding in RA diagnosis (no explicit numerical target, but typically >70% for such markers). | 76.2% (95% CI: 72.1-80.3) |
| Clinical Specificity (Healthy Blood Donors) | High specificity to differentiate from healthy individuals and other diseases (no explicit numerical target, but typically >90%). | 99.2% (95% CI: 97.3 - 99.9%) |
| Clinical Specificity (Non-RA Diseased) | High specificity to differentiate from various non-RA conditions (no explicit numerical target, but ideally >90% for most). | Ranged from 80% (Chlamydia) to 100% (many conditions) |
| Total Clinical Specificity (Non-RA) | Overall high specificity across non-RA conditions. | 98.6% |
| Analytical Performance | ||
| Intra-assay Precision (% CV) | Low variability (e.g., <10-15% for immunoassays). | Ranged from 1.9% to 7.9% |
| Inter-assay Precision (% CV) | Low variability (e.g., <10-15% for immunoassays). | Ranged from 6.3% to 10.6% |
| Batch to Batch Variation (% CV) | Low variability (e.g., <15-20% for immunoassays). | Ranged from 8.3% to 13.3% |
| Dilution Recovery | Recoveries generally within 80-120% of expected values. | Ranged from 84% to 116% |
| Limit of Detection | Low enough to detect clinically relevant levels (no explicit numerical target, but lower is better). | 0.5 U/mL |
| Interference | No significant interference from common interfering substances. | Indicated no interference from tested substances. |
2. Sample Sizes and Data Provenance
- Test Set for Predicate Device Comparison: 678 frozen retrospective sera
- 416 from RA patients
- 262 from apparently healthy blood donors
- Data provenance: Not explicitly stated, but given the manufacturer is Euro-Diagnostica AB in Sweden, it is likely European. The data is retrospective.
- Test Set for Clinical Sensitivity and Specificity: 1209 frozen retrospective sera with clinical characterization.
- 416 from established RA patients
- 793 from non-RA diseased patients and asymptomatic individuals (healthy blood donors)
- Data provenance: Not explicitly stated, but likely European. The data is retrospective.
- Test Set for Linear Correlation: 174 sera from RA patients.
- Data provenance: Not explicitly stated, but likely European. Retrospective.
- Test Sets for Analytical Performance (Precision, Dilution Recovery, Limit of Detection, Interference): Small numbers of pooled or individual samples (e.g., six different samples for precision, three different patient samples for dilution recovery, zero calibrator for LOD, three low positive samples for interference).
- Data provenance: Not explicitly stated. Likely performed in the manufacturer's lab.
3. Number of Experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not specify the number of experts or their qualifications for establishing the ground truth.
4. Adjudication Method
The document does not describe any adjudication method for establishing the ground truth. It states "Patients with clinically defined RA" and "frozen retrospective sera with clinical characterisation," suggesting the clinical status was pre-determined based on existing medical records/diagnoses prior to the study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This study is for an in-vitro diagnostic (IVD) kit that measures a biomarker. MRMC studies are typically performed for imaging devices or other diagnostic tools where human interpretation is a primary component of the diagnostic process. This kit's output is a quantitative measure (U/mL) and a positive/negative result, which does not involve human readers in the same way.
6. Standalone Performance
Yes, this study primarily focuses on the standalone performance of the EDIA™ anti-CCP kit. The clinical sensitivity and specificity results in Tables 2 and 3 represent the algorithm's (the assay's) performance independent of human interpretation (beyond laboratory technicians performing the assay). The comparison to the predicate device also evaluates the standalone performance of the new device against an existing standalone device.
7. Type of Ground Truth Used
The ground truth for the clinical performance studies was based on:
- Clinical Characterization/Clinically Defined RA: This implies a diagnosis made by physicians based on established diagnostic criteria for Rheumatoid Arthritis, likely involving clinical signs, symptoms, imaging, and other laboratory tests.
- Healthy Blood Donors and Non-RA Diseased Patients: These classifications serve as controls or negative ground truths, indicating the absence of RA or the presence of other specific conditions.
For the predicate device comparison, the ground truth was the result obtained from the Immunoscan RA anti-CCP test kit.
For analytical studies (precision, detection limit, dilution recovery, interference), the ground truth is predefined theoretical values or established experimental protocols to assess the assay's fundamental performance characteristics.
8. Sample Size for the Training Set
The document does not explicitly describe a separate "training set" for the EDIA™ anti-CCP kit. ELISA-based assays are developed using established biochemical principles and reagents, and their "training" typically involves optimizing the assay components and parameters during the development phase, rather than statistical machine learning training on a distinct data set. The provided data represents evaluation or validation sets.
9. How the Ground Truth for the Training Set was Established
As no explicit training set for an algorithm is described, this question is not directly applicable. The "ground truth" during the development and optimization of such an assay would involve known concentrations of antibodies, reference standards, and samples with confirmed clinical status to fine-tune the assay's performance characteristics.
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