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510(k) Data Aggregation
(232 days)
SQI DIAGNOSTICS SYSTEMS INC.
The Ig plex Celiac DGP Panel is an in vitro diagnostic test for the semi-quantitative detection of the IgA and IgG immunoglobulin classes of antibodies to deamidated gliadin peptide (DGP) and tissue transglutaminase (TG) in human serum. The test is intended for use in clinical laboratories as an aid in the disease in conjunction with other laboratory and clinical findings, and requires the sqid-X system.
The Ig plex Celiac DGP Panel is a consumable reagent kit. It is designed to run on the sqid-X system. The kit includes a microarray plate, reporter mix, standards, controls, sample diluents, wash buffer concentrates and a CD-ROM.
The assay detects the presences of the IgA and IgG classes of antibody, and the IgA and lgG classes of anti-tissue transglutaminase antibody. This is performed in an integrated fashion on the sqid-X system that reports all analytes simultaneously to aid in the diagnosis of celiac disease.
The system is a multiplex immunoassay analyzer that semi-automates the protocol of a specific lg plex assay from plate washing to reporting of all assay markers for each individual patient sample. The system combines manual liquid handling (samples and reagents) with automated steps for washing, scanning, data analyses and reporting. Results for each patient sample are obtained simultaneously for each of the four markers using the results from one well containing one aliquot of the patient's serum. Results are reported independently.
Here's a summary of the acceptance criteria and study findings for the Ig plex Celiac DGP Panel, based on the provided document:
1. Table of Acceptance Criteria & Reported Device Performance
The document does not explicitly state formal "acceptance criteria" in a go/no-go fashion with numerical targets for all performance metrics. However, it presents various performance results without indicating that they failed to meet any internal or regulatory thresholds. The following table summarizes what can be inferred as the expected performance based on the reported study results:
| Performance Metric | Acceptance Criteria (Inferred/Implied from Reported Performance) | Reported Device Performance (Ig plex Celiac DGP Panel) |
|---|---|---|
| Clinical Sensitivity | Acceptable sensitivity for each analyte | tTG IgA: 98.4% (95% CI: 97.3-99.5%) |
| tTG IgG: 46.9% (95% CI: 42.5-51.3%) | ||
| DGP IgA: 79.7% (95% CI: 76.1-83.2%) | ||
| DGP IgG: 89.1% (95% CI: 86.3-91.8%) | ||
| Clinical Specificity | Acceptable specificity for each analyte | tTG IgA: 100.0% (95% CI: 100.0-100.0%) |
| tTG IgG: 98.8% (95% CI: 98.1-99.5%) | ||
| DGP IgA: 99.2% (95% CI: 98.6-99.8%) | ||
| DGP IgG: 99.6% (95% CI: 99.2-100.0%) | ||
| Analytical Interference | Clinically acceptable recoveries (bias ≤15%) for specified interferents at given concentrations | Met for Bilirubin (0.15 mg/mL), Hemoglobin (5.00 mg/mL), Triglycerides (5.00 mg/mL), and Human IgG (0.50 mg/mL) across all analytes. |
| Method Agreement (Positive) | High positive agreement with predicate methods | tTG IgA: 100.0% (95% CI: 97.2-100.0%) |
| tTG IgG: 94.1% (95% CI: 84.1-98.0%) | ||
| DGP IgA: 93.3% (95% CI: 87.8-96.5%) | ||
| DGP IgG: 98.5% (95% CI: 94.6-99.6%) | ||
| Method Agreement (Negative) | High negative agreement with predicate methods | tTG IgA: 87.9% (95% CI: 82.5-91.8%) |
| tTG IgG: 84.6% (95% CI: 79.3-88.7%) | ||
| DGP IgA: 95.1% (95% CI: 90.9-97.4%) | ||
| DGP IgG: 90.3% (95% CI: 85.3-93.7%) | ||
| Method Agreement (Overall) | High overall agreement with predicate methods | tTG IgA: 92.9% (95% CI: 89.5-95.2%) |
| tTG IgG: 86.3% (95% CI: 81.8-89.9%) | ||
| DGP IgA: 94.3% (95% CI: 91.2-96.4%) | ||
| DGP IgG: 93.6% (95% CI: 90.4-95.7%) | ||
| Precision (Inter-assay, Lot-to-Lot, Instrument-to-Instrument) | Acceptable %CV values for various concentrations across different precision studies (generally |
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(275 days)
SQI DIAGNOSTICS SYSTEMS
The IgX PLEX™ Celiac Qualitative Assay is an in vitro diagnostic test for the qualitative detection of the IgA and IgG immunoglobulin classes of anti-tissue transglutaminase antibody in serum. The test is intended for use in clinical laboratories as an aid in the diagnosis of celiac disease in conjunction with other laboratory and clinical findings, and requires the SQiDworks™ Diagnostics Platform.
The IgX PLEX™ Celiac Qualitative Assay is a consumable reagent kit. It is designed to run on the SQiDworks™ Diagnostics Platform. The kit includes a Microarray Plate, Reporter mix, standards, controls, sample diluents, wash buffer concentrates and a CD-ROM.
The Assay Kit detects the presences of the IgG classes of anti-tissue transglutaminase antibody. This is performed in an integrated fashion on the SQiDworks™ Diagnostics Platform (platform) that reports both analytes simultaneously to aid in the diagnosis of Celiac Disease.
The platform automates the entire immunoassay procedure from end-to-end, including calibrator/standards and sample pipetting, sample dilution, incubation, washing, and drying. Once the assay's biochemical reactions have completed, the instrument automatically performs a multi-color fluorescent scan of each well in the microarray, analyzes the data, and generates a report containing qualitative results for both assay markers. Results for each patient sample from the IgX PLEX™ Celiac Qualitative assay are obtained simultaneously for each of the two markers using the results from one well containing one aliquot of the patient's serum. Results are reported independently.
Here's a breakdown of the acceptance criteria and study information for the IgX PLEX™ Celiac Qualitative Assay, based on the provided text:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Reproducibility | Anti-tTG-IgA Reproducibility | High (not explicitly quantified but demonstrated by results) | 92.4% to 100% |
| Anti-tTG-IgG Reproducibility | High (not explicitly quantified but demonstrated by results) | 95.8% to 100% | |
| Clinical Performance | Anti-tTG-IgA Clinical Sensitivity | High (not explicitly quantified but demonstrated by results) | 98.3% |
| Anti-tTG-IgG Clinical Sensitivity | High (not explicitly quantified but demonstrated by results) | 80.9% | |
| Anti-tTG-IgA Clinical Specificity | High (not explicitly quantified but demonstrated by results) | 94.5% | |
| Anti-tTG-IgG Clinical Specificity | High (not explicitly quantified but demonstrated by results) | 89.0% | |
| Agreement with Predicates | Anti-tTG-IgA Overall Agreement | High (not explicitly quantified but demonstrated by results) | 89.3% |
| Anti-tTG-IgG Overall Agreement | High (not explicitly quantified but demonstrated by results) | 85.1% | |
| Interference | Effect of high bilirubin levels | No significant impact | None affected |
| Effect of high hemoglobin levels | No significant impact | None affected | |
| Effect of high triglycerides levels | No significant impact | None affected | |
| Effect of high human IgG levels | No significant impact | None affected |
Study Information
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Sample size used for the test set and the data provenance:
- The document does not specify the sample size used for the test set.
- The document does not specify the data provenance (e.g., country of origin, retrospective or prospective).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The study focuses on "clinical sensitivity" and "specificity" and "overall agreement with established predicate test systems," which suggests comparison to existing diagnostic methods rather than a panel of human experts for ground truth in the traditional sense for image-based AI.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not provided in the document.
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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:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is an in vitro diagnostic (IVD) assay that automates the immunoassay procedure and provides qualitative results, intended to aid in diagnosis in conjunction with other clinical findings, rather than an AI system assisting human readers of images.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the performance metrics reported (reproducibility, clinical sensitivity, specificity, agreement) directly reflect the standalone performance of the IgX PLEX™ Celiac Qualitative Assay. The device is an automated system described as running "from end-to-end" and generating reports with "qualitative results." Human "in-the-loop" performance in the sense of an algorithm assisting a human reader is not applicable here as it autonomously provides the diagnostic result.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The document implies that the ground truth for "clinical sensitivity" and "specificity" and "overall agreement" was established by comparison to established predicate test systems and presumably clinical diagnoses of celiac disease. It does not explicitly state the ultimate "ground truth" method (e.g., small intestinal biopsy for celiac disease diagnosis, which is the gold standard). The phrase "aid in the diagnosis of celiac disease in conjunction with other laboratory and clinical findings" suggests that the "true" diagnosis of celiac disease, against which the assay's performance is measured, would involve a combination of clinical information, and potentially the gold standard of biopsy.
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The sample size for the training set:
- This information is not provided. The description mentions "standards, controls, sample diluents" as part of the kit, which are generally used for calibration and quality control rather than a "training set" in the machine learning sense.
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How the ground truth for the training set was established:
- This information is not provided. As this is an IVD assay rather than a machine learning model, the concept of a "training set" and establishing its ground truth in the typical AI/ML context doesn't directly apply in the same way.
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(378 days)
SQI DIAGNOSTICS SYSTEMS
The IgX PLEX™ Rheumatoid Arthritis Qualitative Assay and SQiDworks™ Diagnostics Platform is an in vitro diagnostic test system for the qualitative detection of the IgA and IgM classes of Rheumatoid Factors, and the IgG class of anti-cyclic citrullinated peptide antibodies (CCPproprietary third generation equivalent formulation) in human serum specimens.
The IgX PLEXTM Rheumatoid Arthritis Qualitative Assay is intended for use in clinical laboratories as an aid in the diagnosis of Rheumatoid Arthritis in conjunction with other laboratory and clinical findings, and requires the SQiDworks™ Diagnostics Platform.
The device consists of the IgX PLEX™ Rheumatoid Arthritis Qualitative Assay (RL1 kit) and the SQiDworks™ Diagnostics Platform (the Platform); the Platform incorporates the SQiDworks™ Integrated Software (the Software). The Platform is a multiplex immunoassay instrument that fully automates the process of a specific IgX PLEX™ Assay from serum transfer to reporting of all assay markers for each individual patient sample. Once the assay's biochemical reactions have completed, the instrument automatically performs a multi-color fluorescent scan of each well in the microarray, analyzes the data, and generates a report containing qualitative results for all assay markers. The SQiDworks Diagnostics Platform also includes numerous internal quality checks and user safety features with fail-safe and interlock mechanisms.
The instrument integrates an automated pipetting station, a fluorescent scanner, washing and drying stations, and other ancillary hardware components using dedicated instrument control. In addition, the software provides scheduling, self-verification, data acquisition, data management, analysis algorithms and reporting software.
Results for each patient sample from the IgX PLEXIM Rheumatoid Arthritis Qualitative Assay and the SQiDworks™ Diagnostics Platform are obtained simultaneously for cach of the three assay markers: RF IgM, RF IgA and CCP IgG using the results from one well containing one aliquot of the patient's serum. Results are reported independently.
The IgX PLEXIM Rheumatoid Arthritis Qualitative Assay (RL1) kit consists of two boxes (with different temperature requirements) of components as described below.
The provided document describes the IgX PLEX™ Rheumatoid Arthritis Qualitative Assay and SQiDworks™ Diagnostics Platform. Here's a breakdown of the acceptance criteria and study details based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document lists performance characteristics from nonclinical (in-house) studies. It describes ranges for reproducibility, clinical sensitivity, clinical specificity, and overall agreement with predicate devices rather than pre-defined acceptance criteria with specific thresholds. It implies these ranges demonstrate the safety and effectiveness for intended use.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Reproducibility (RF IgA) | Expected to be high for consistent results | 95.0%-100% |
| Reproducibility (RF IgM) | Expected to be high for consistent results | 96.3%-100% |
| Reproducibility (CCP IgG) | Expected to be high for consistent results | 83.3%-100% |
| Clinical Sensitivity (RF IgA) | (Not explicitly stated, but consistent with literature references) | Not explicitly stated for RF IgA, but overall ranged from 77.7% to 93.3% |
| Clinical Sensitivity (RF IgM) | (Not explicitly stated, but consistent with literature references) | 93.3% |
| Clinical Sensitivity (CCP IgG) | (Not explicitly stated, but consistent with literature references) | 77.7% |
| Clinical Specificity (RF IgA) | (Not explicitly stated, but consistent with literature references) | 92.7% |
| Clinical Specificity (RF IgM) | (Not explicitly stated, but consistent with literature references) | Not explicitly stated for RF IgM, but overall ranged from 92.7% to 96.0% |
| Clinical Specificity (CCP IgG) | (Not explicitly stated, but consistent with literature references) | 96.0% |
| Overall Agreement (RF IgA) with predicate | Expected to show substantial equivalence | 85% |
| Overall Agreement (RF IgM) with predicate | Expected to show substantial equivalence | Not explicitly stated for RF IgM, but overall ranged from 85% to 95% |
| Overall Agreement (CCP IgG) with predicate | Expected to show substantial equivalence | 95% |
| Interference | No significant interference from common biological substances | None of the analytes affected by high levels of bilirubin, hemoglobin, triglycerides, and human IgG |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "A series of nonclinical (in-house) studies were conducted," but it does not specify the sample size for the test set used in these studies. The data provenance is stated as "in-house" studies, implying it was conducted by the manufacturer, SQI Diagnostics Systems, Inc., which is based in Toronto, Ontario, Canada. It does not explicitly state whether the studies were retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document states that "clinical diagnosis (RA or non-RA, including normals) was used as the reference result" for clinical sensitivity and specificity. However, it does not specify the number or qualifications of experts who established this clinical diagnosis (ground truth). It also does not mention if experts were used for interpreting the device's results in the study.
4. Adjudication Method for the Test Set:
The document does not provide information on any adjudication method used for the test set, or for establishing the clinical diagnosis that served as ground truth.
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:
This device is an in vitro diagnostic test system that automates the process from serum transfer to reporting of assay markers. It does not involve human "readers" in the context of interpreting images or complex data that would typically necessitate an MRMC comparative effectiveness study with AI assistance. Therefore, no MRMC comparative effectiveness study involving human readers with and without AI assistance was done.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, the studies described are for the "IgX PLEX™ Rheumatoid Arthritis Qualitative Assay and SQiDworks™ Diagnostics Platform." The platform "fully automates the process... from serum transfer to reporting of all assay markers." The performance characteristics described (reproducibility, clinical sensitivity, specificity, agreement) refer to the performance of this automated system, i.e., the algorithm/device primarily in a standalone capacity. While the intended use requires it in conjunction with other laboratory and clinical findings, the reported performance metrics are for the device's direct output.
7. The Type of Ground Truth Used:
For clinical sensitivity and specificity, the ground truth was clinical diagnosis (RA or non-RA, including normals). For the study assessing overall agreement, the predicate test systems (Quanta LITE™ RF IgA ELISA, Quanta LITE™ RF IgM ELISA, and Quanta LITE™ CCP3 IgG ELISA) served as the reference for comparison.
8. The Sample Size for the Training Set:
The document does not provide information on the sample size used for any training set. Given the nature of a multiplex immunoassay instrument and assay, "training set" might refer to data used for establishing assay parameters, cutoff values, or calibration curves rather than machine learning model training in the typical sense. However, no specifics are provided.
9. How the Ground Truth for the Training Set Was Established:
The document does not mention a distinct "training set" or how its ground truth would have been established. It only discusses the ground truth for the clinical validation referenced in the performance characteristics section. For calibrators, it mentions they are "eight dilutions of a sample derived from human sera containing an appropriate representation of each of the analytes to be reported" and that "The assay standards (secondary standards) for RF (IgA and IgM) are traceable to the WHO/First British Standard 64/2 (primary standards)." For CCP IgG, it states "results are internally calculated in U/mL and are comparable to other assays on the market." This suggests a process of using established standards and internal calculations to define quantitative values, which are then converted to qualitative results based on assay-specific cutoff values.
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