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510(k) Data Aggregation
(24 days)
The Diamedix Immunosimplicity (Is) ANA ELISA ScreenTest Kit is a qualitative enzyme immunoassay intended to screen for the presence of antinuclear antibodies (ANAs) in human serum as an aid in the diagnosis of certain systemic rheumatic diseases. This assay collectively detects in one well, total ANAs against double-stranded DNA (dsDNA and nDNA), Histones, SSA, SSB, Sm, Sm/RNP, Scl-70, Jo-1 and centromeric antigens along with sera positive for Immunofluorescent (IF) HEp-2 ANAs. These reagents can be used either manually or in conjunction with the MAGO Plus Automated EIA Processor.
The Is-ANA ELISA ScreenTest System is an enzyme-linked immuno-Device Description: The 15 Privated of anti-nuclear antibodies (ANA) in human serum.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Is-ANA ELISA Screen Test System:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a numerical table for the performance characteristics. Instead, it presents the results of its performance studies (relative sensitivity/specificity, clinical sensitivity/specificity, and precision) which implicitly serve as the achieved performance against an assumed set of internal or regulatory expectations.
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance (Manual) | Reported Device Performance (MAGO Plus) |
|---|---|---|---|
| Relative Sensitivity (vs. Other ELISA Manual) | High (e.g., >90%) | 95.9% (92.1-98.2% CI) | 97.3% (93.9-99.1% CI) |
| Relative Specificity (vs. Other ELISA Manual) | High (e.g., >90%) | 95.5% (89.9-98.5% CI) | 93.8% (87.5-97.5% CI) |
| Overall Agreement (vs. Other ELISA Manual) | High (e.g., >95%) | 95.8% (92.7-97.7% CI) | 96.0% (93.1-97.9% CI) |
| Relative Sensitivity (vs. Other ELISA MAGO Plus) | High (e.g., >90%) | 96.9% (93.3-98.8% CI) | 97.9% (94.6-99.4% CI) |
| Relative Specificity (vs. Other ELISA MAGO Plus) | High (e.g., >90%) | 95.7% (90.1-98.6% CI) | 94.0% (88.0-97.5% CI) |
| Overall Agreement (vs. Other ELISA MAGO Plus) | High (e.g., >95%) | 96.4% (93.7-98.2% CI) | 96.4% (93.6-98.2% CI) |
| Clinical Specificity (Normal Sera) | High (e.g., >85%) | 89.5% (84.3-94.7% CI) | 89.2% (83.9-94.6% CI) |
| Clinical Sensitivity (Low Titer ANA+ Sera) | High (e.g., >88%) | 88.2% (72.6-96.7% CI) | 100.0% (89.7-100.0% CI) |
| Clinical Sensitivity (High Titer ANA+ Sera) | High (e.g., >90%) | 100.0% (90.0-100.0% CI) | 100.0% (90.0-100.0% CI) |
| Clinical Sensitivity (Monospecific Sera) | High (e.g., >90%) | 100.0% (92.1-100.0% CI) | 100.0% (92.0-100.0% CI) |
| Clinical Sensitivity (Autoimmune Disease Sera) | High (e.g., >90%) | 100.0% (94.9-100.0% CI) | 98.5% (91.7-100.0% CI) |
| Precision (CV% - Intra-assay & Inter-assay) | Low (e.g., 0.9) | 0.9712 | Not Applicable |
2. Sample Sizes Used for the Test Set and Data Provenance:
-
Relative Sensitivity and Specificity Comparison:
- Test Set Size: 146 sera from normal blood donors and 185 sera from clinical patients (total 331 sera). Some samples were excluded due to equivocal results, leading to slightly smaller effective sample sizes in the calculations (e.g., 308, 306, 300, 303).
- Data Provenance: Not explicitly stated (e.g., country of origin). Likely from general laboratory or donor populations relevant to the manufacturer. The data appears retrospective as existing sera were tested.
-
Clinical Sensitivity and Specificity using Characterized Sera:
- Test Set Size: 331 characterized sera, specifically:
- 146 Normal Blood Donor Sera
- 45 Monospecific Sera
- 70 IFA-ANA Positive Sera (35 low titer, 35 high titer)
- 70 Autoimmune Disease State Sera
- Data Provenance: Not explicitly stated (e.g., country of origin). "Sera obtained from a variety of sources" suggests diverse origins, but specific countries or "retrospective/prospective" are not mentioned.
- Test Set Size: 331 characterized sera, specifically:
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- For the Relative Sensitivity and Specificity comparison, the ground truth was established by a "comparative method" (another commercially available ANA Screen test). This implies the "expert" was the predicate device's performance, not human experts.
- For the Clinical Sensitivity and Specificity using Characterized Sera, the ground truth for normal blood donors was based on their classification as "normal." For monospecific, IFA-ANA positive, and autoimmune disease sera, the ground truth was based on pre-characterization ("known ANA reactivity" or "diagnosed with an autoimmune disorder" or "shown to be positive by the IFA-ANA method"). No mention of human experts defining these specific ground truths for the purpose of this study. The term "characterized sera" implies prior expert diagnosis or classification, but the number and qualifications of those experts are not detailed in this submission.
4. Adjudication Method for the Test Set:
- There is no explicit mention of an adjudication method involving human reviewers or a specific process like 2+1 or 3+1 for the results of the Is-ANA ELISA Screen Test Kit.
- For the relative comparison, it states samples "equivocal in either or both methods were excluded from calculations." This acts as a form of "adjudication by exclusion" rather than a consensus-based review for the equivocal cases.
- For the clinical sensitivity/specificity, the "characterized sera" were used, meaning their status was pre-determined.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done. This study evaluates an in vitro diagnostic device (IVDD) which screens for antibodies in serum. These devices are typically evaluated based on their analytical and clinical performance characteristics (sensitivity, specificity, precision) against reference methods or established patient cohorts, not by comparing human reader performance with and without AI assistance. The "AI" in this context refers to the MAGO Plus Automated EIA Processor, which is an automation system for the assay, not an AI for image interpretation or diagnosis.
6. Standalone Performance Study:
- Yes, a standalone performance study was done. The entire "Performance Characteristics" section details the standalone performance of the Is-ANA ELISA Screen Test System, both when performed manually and when run on the MAGO Plus Automated EIA Processor. This includes:
- Relative Sensitivity and Specificity (comparing it to an existing method).
- Clinical Sensitivity and Specificity (evaluating its performance against defined patient populations and known antibody reactivities).
- Precision studies.
- Correlation between manual and automated (MAGO Plus) results.
The primary goal is to show the device's ability to detect ANA.
7. Type of Ground Truth Used:
- Comparative Method Results: For relative sensitivity and specificity, the ground truth was the results obtained from "another commercially available ANA Screen test."
- Established Clinical Status/Pathology/Known Reactivity: For clinical sensitivity and specificity:
- Normal Blood Donor Sera: Implied ground truth of "absence of significant ANA" based on healthy donor status.
- Monospecific Sera: Ground truth based on known, characterized presence of "monospecific antibodies of clinical significance."
- IFA-ANA Positive Sera: Ground truth established by being "shown to be positive by the IFA-ANA method" with specified titers. IFA (Immunofluorescence Assay) is a widely accepted reference method for ANA detection.
- Autoimmune Disease State Sera: Ground truth based on patients "diagnosed with an autoimmune disorder." This is a form of clinical outcome/diagnosis ground truth.
8. Sample Size for the Training Set:
- The document does not mention a separate training set or its sample size. This type of in vitro diagnostic device typically undergoes method validation and performance studies, which don't usually involve "training sets" in the same way machine learning algorithms do. The studies described are performance evaluations, not algorithm training.
9. How the Ground Truth for the Training Set Was Established:
- As a training set is not mentioned, the method for establishing its ground truth is not applicable in this document.
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