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510(k) Data Aggregation
(86 days)
DIAMEDIX IS-ANTI-CARDIOLIPIN IGA TEST SYSTEM
The Diamedix Is anti-Cardiolipin IgA Test Kit is an indirect enzyme immunoassay (EIA) for the semi-quantitative measurement of IgA antibodies to cardiolipin in human serum as an aid in the assessment of the risk of thrombosis in patient with SLE or SLE-like disorders. The assay can be used either manually or in conjunction with the MAGO® Plus Automated EIA Processor.
The Is anti-Cardiolipin IgA Test System is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative measurement of IgA antibodies to cardiolipin in human serum
The provided submission K012450 describes the "Is anti-Cardiolipin IgA Test System," an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative measurement of IgA antibodies to cardiolipin in human serum. The results are intended to aid in assessing the risk of thrombosis in patients with SLE or SLE-like disorders.
Here's an analysis of the acceptance criteria and study findings:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state pre-defined acceptance criteria with numerical targets in the "Performance Characteristics" section. However, the studies presented imply that the observed performance values were considered acceptable for demonstrating substantial equivalence. The predicate device's performance would serve as an implicit benchmark.
Based on the provided data, the following table summarizes the reported device performance:
| Performance Metric | Reported Device Performance | Implicit Acceptance Criteria (based on predicate equivalence) |
|---|---|---|
| Relative Sensitivity | 85.7% (95% CI: 75.3-92.9%) | Comparable to predicate device |
| Relative Specificity | 99.3% (95% CI: 96.2-100.0%) | Comparable to predicate device |
| Overall Agreement (relative) | 94.8% (95% CI: 90.9-97.4%) | Comparable to predicate device |
| 3-point vs 6-point calibration | Correlation coefficient (r): 0.9836 (95% CI: 0.9782 to 0.9877); Coefficient of determination: 0.9675 | Strong linear correlation expected, indicating equivalence of calibration methods. |
| Correlation with Comparative Method | Correlation coefficient (r): 0.9632 (95% CI: 0.9527 to 0.9714); Coefficient of determination: 0.9277 | Strong linear correlation expected, indicating comparability to other methods. |
| Analytical Sensitivity (LoD) | 0.2 APL U/ml | Not explicitly compared to a specific acceptance criterion, but low LoD is desirable. |
| Clinical Specificity (Normals) | 98.1% (210/214) | High specificity in healthy populations. |
| Clinical Specificity (RPR Positive) | 80.0% (12/15) | Acceptable specificity in a potentially cross-reactive group. |
| Clinical Sensitivity (APS) | 43.8% (25/57) | Demonstrating ability to detect in target population. |
| Clinical Sensitivity (SLE) | 36.4% (12/33) | Demonstrating ability to detect in target population. |
| Clinical Sensitivity (Other Autoimmune) | 8.6% (3/35) | Expected lower sensitivity in non-target autoimmune diseases. |
| Cross-Reactivity | 2 out of 36 samples reactive (1 Jo-1, 1 dsDNA) | Low incidence of cross-reactivity with common autoantibodies. |
| Linearity | Correlation coefficient (r): 0.9956 (95% CI: 0.9691 to 0.9994); Coefficient of determination: 0.9912 | Strong linear correlation across dilution range. |
| Manual vs. MAGO Plus Correlation | Correlation coefficient (r): 0.9688 (reported for 6-point calibration); 0.9794 (for 3-point calibration) | Strong linear correlation expected, indicating equivalence across methods. |
| Precision (Interassay CV%) | Ranges from 4.57% to 29.54% (Manual); 9.95% to 20.63% (MAGO Plus) | Acceptable reproducibility for a semi-quantitative assay across different runs. |
2. Sample sizes for the test set and data provenance:
- 3-point vs 6-point calibration:
- Sample Size: 190 samples
- Data Provenance: Not explicitly stated (e.g., country of origin). Implied to be retrospective as they are "results of 190 samples tested."
- Relative Sensitivity and Specificity:
- Sample Size: 237 frozen retrospective sera.
- Data Provenance: Retrospective, provenance not specified (e.g., country of origin).
- Clinical Sensitivity and Specificity:
- Sample Size: 354 frozen retrospective, clinically characterized sera.
- Data Provenance: Retrospective, provenance not specified (e.g., country of origin).
- Cross Reactivity:
- Sample Size: 36 samples.
- Data Provenance: Not explicitly stated, context implies retrospective.
- Linearity:
- Data Provenance: Not explicitly stated, likely laboratory-prepared dilutions of highly positive samples.
- Manual and MAGO Plus results correlation:
- Sample Size: 190 serum samples.
- Data Provenance: Not explicitly stated (e.g., country of origin). Implied to be retrospective.
- Precision:
- Sample Size: 6 serum samples of varying reactivity. Each tested in triplicate in three separate runs (total of 9 measurements per sample for inter-assay).
- Data Provenance: Not explicitly stated, likely laboratory samples.
- Expected Values (Normal Population):
- Sample Size: 148 sera from a "normal, healthy population."
- Data Provenance: South Florida, likely prospective collection of healthy individuals.
- Expected Values (Clinical Population - APS):
- Sample Size: 57 sera from patients with a diagnosis of anti-phospholipid syndrome (APS).
- Data Provenance: Not explicitly stated, likely retrospective collection from a clinical setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The submission does not mention the use of experts to establish ground truth for any of the test sets. The ground truths were established by:
- Comparative method: For relative sensitivity/specificity (using a "commercially available ELISA kit for detecting cardiolipin IgA antibodies" and a "referee EIA method").
- Clinical diagnosis: For clinical sensitivity/specificity ("patients with diagnosed antiphospholipid syndrome (APS)", "patients with systemic lupus erythematosus (SLE)", "patients with other autoimmune diseases", "patients with positive RPR titers").
- Established serological reactivity: For cross-reactivity ("samples which were reactive to various autoantibodies (SSA/SSB, Scl-70, Jo-1, dsDNA and RF)").
4. Adjudication method for the test set:
No adjudication method is mentioned for the establishment of ground truth in any of the studies. All ground truths appear to be based on existing clinical diagnoses or results from other established assays. For the "Relative Sensitivity and Specificity" study, "Further resolution of the discordant samples" was done using a "referee EIA method," which acts as a secondary resolution mechanism rather than an expert adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
No, this device is an in-vitro diagnostic (IVD) assay, not an AI-powered image analysis or diagnostic support tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance was not performed and is not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The device itself is a standalone assay. The performance characteristics described (relative sensitivity/specificity, clinical sensitivity/specificity, precision, linearity, correlation with automated platform) all represent the "algorithm only" or device-only performance without human interpretation being a variable in the primary performance measures. The "Manual vs MAGO Plus" correlation study demonstrates the device's performance across two modes of operation (manual vs. automated), both of which are standalone in their result generation.
7. The type of ground truth used:
- Other ELISA kit and a referee EIA method: Used for "Relative Sensitivity and Specificity."
- Clinical diagnosis: For "Clinical Sensitivity and Specificity" (e.g., diagnosed APS, SLE, other autoimmune diseases, RPR positive).
- Serological reactivity to specific autoantibodies: For "Cross Reactivity."
- Established concentrations/dilutions: For "Linearity" and "Precision."
- Healthy population status and APS diagnosis: For "Expected Values."
8. The sample size for the training set:
The submission does not explicitly define a "training set" in the context of machine learning or AI development, as this is an ELISA assay. Therefore, there is no specified sample size for a training set in that sense. The studies described are performance evaluation studies, not algorithm training studies.
9. How the ground truth for the training set was established:
Not applicable, as there is no mention of an AI/ML training set in the context of this traditional IVD assay.
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