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510(k) Data Aggregation
(84 days)
The Access sTfR assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of soluble transferrin receptor (sTR) levels in human serum and plasma (heparin) using the Access Immunoassay Systems. This assay is intended as an aid in the diagnosis of Iron Deficiency Anemia (IDA), and for the differential diagnosis of IDA and Anemia of Chronic Disease (ACD).
This assay may also be used in conunction with an Access Ferritin measurement to provide a calculated sTR log ferritin index. This index is intended as an aid in the diagnosis of IDA, and for the differential diagnosis of IDA and ACD.
Access sTfR: The sTfR assay reagent pack consists of two specific reagents: (R1a) paramagnetic particles coated with streptavidin:biotinylated soluble transferrin receptor monoclonal antibody, proteins (mouse, goat, bovine), bovine serum albumin (BSA), 0.1% sodium azide, and 0.17% ProClin 300; and (R1b) Monoclonal mouse anti-human soluble transferrin receptor alkaline phosphatase (bovine) conjugate, BSA, 0.1% sodium azide and 0.17% ProClin 300. Two assay packs containing 50 tests per pack are provided for a total of 100 assay determinations.
The Access sTfR assay is a sequential two-step immunoenzymatic ("sandwich") assay. A sample is added to a reaction vessel along with paramagnetic particles coated with anti-sTfR antibody. During incubation, the sTfR antigen in the sample binds to the immobilized anti-sTfR antibody on the solid phase. Alkaline phosphatase conjugated anti-sTfR antibody is then added and reacts with a different antigenic site on the sTfR molecule.
After incubation, materials bound to the solid phase are held in a magnetic field while unbound materials are washed away. Then, the chemiluminescent substrate is added to the vessel and light generated by the reaction is measured with a luminometer. The light production is directly proportional to the concentration of analyte in the sample. Analyte concentration is automatically determined from a stored calibration.
Here's a breakdown of the acceptance criteria and study information for the Access sTfR device, based on the provided FDA 510(k) summary:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance | Meets Criteria? |
|---|---|---|---|
| Method Comparison | Slope: 0.99 – 1.01 (95% CI) | Slope: 1.00 (95% CI: 0.99 – 1.01) | Yes |
| Intercept: -0.14 - 0.15 (95% CI) | Intercept: -0.016 (95% CI: -0.14 - 0.15) | Yes | |
| Correlation Coefficient (R): Not explicitly stated as acceptance, but comparison shows R = 1.00 | Correlation Coefficient (R): 1.00 | Yes (Excellent) | |
| Imprecision | ≤ 0.72 nmol/L SD at concentrations ≤ 9 nmol/L | Sample 1 (9.1 nmol/L): 0.24 nmol/L SD | Yes |
| ≤ 8.0% CV at concentrations > 9 nmol/L | Sample 2 (17 nmol/L): 2.6% CV < 8% | Yes | |
| Sample 3 (20 nmol/L): 2.4% CV < 8% | Yes | ||
| Sample 4 (33 nmol/L): 1.8% CV < 8% | Yes | ||
| Sample 5 (67 nmol/L): 2.0% CV < 8% | Yes | ||
| Sample 6 (118 nmol/L): 2.2% CV < 8% | Yes | ||
| Linearity | "The assay demonstrated linearity across the measuring interval." | "The assay demonstrated linearity across the measuring interval." | Yes (Direct statement) |
| Detection Capability | Not explicitly stated as acceptance criteria, but listed as targets to be determined. | LoB: 0.04 nmol/L | Achieved targets |
| LoD: 0.05 nmol/L | Achieved targets | ||
| LoQ: 0.05 nmol/L (≤ 20% within-lab CV) | Achieved targets |
Study Details
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Sample size used for the test set and the data provenance:
- Method Comparison: N = 200 patient samples.
- Imprecision: N = 6 samples (Sample 1-6) tested in duplicate, in 2 runs/day for a minimum of 20 days (total N for each sample is 80 measurements).
- Linearity & Detection Capability: Sample sizes for these specific studies are not explicitly stated, but the studies were performed on the Dxl 9000 Access Immunoassay Analyzer.
- Data Provenance: Not specified in the provided document (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 device is an in vitro diagnostic (IVD) immunoassay for the quantitative determination of soluble transferrin receptor (sTfR) levels. The performance studies (method comparison, imprecision, linearity, detection capability) do not involve human experts establishing a "ground truth" in the way an imaging AI might. Instead, the "ground truth" (or reference standard) for method comparison is the measurement from the predicate device (Access sTfR Assay on Access 2 Immunoassay System). For imprecision, linearity, and detection capability, the ground truth is established by the analytical measurement procedures themselves against defined statistical targets.
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Adjudication method for the test set:
- Not applicable. As noted above, this is an IVD immunoassay, not a system requiring human adjudication of results in the traditional sense. The reference method (predicate device) serves as the comparator for the method comparison study.
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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:
- Not applicable. This is an IVD immunoassay, not an imaging AI or a device that assists human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, the performance studies (method comparison, imprecision, linearity, detection capability) represent the standalone performance of the Access sTfR assay on the Dxl 9000 Access Immunoassay Analyzer. Its output is a quantitative sTfR value.
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The type of ground truth used:
- Method Comparison: Measurements from the predicate device (Access sTfR Assay on Access 2 Immunoassay System). This serves as the reference for comparison against the new device.
- Imprecision, Linearity, Detection Capability: Analytical measurements are compared against pre-defined statistical performance targets (e.g., SD, CV, LoB, LoD, LoQ) established according to CLSI guidelines.
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The sample size for the training set:
- Not applicable. This is a conventional immunoassay, not a machine learning/AI device requiring a separate "training set" in that context. The device uses established biochemical reactions and a stored calibration curve.
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How the ground truth for the training set was established:
- Not applicable (see above). The device establishes its "calibration" using internal calibrators and controls to create a stored calibration curve, as is typical for immunoassays. This is distinct from machine learning model training with labeled ground truth data.
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(158 days)
The Access sTfR assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of soluble transferrin receptor (sTfR) levels in human serum and plasma (heparin) using the Access Immunoassay Systems. This assay is intended as an aid in the diagnosis of Iron Deficiency Anemia (IDA), and for the differential diagnosis of IDA and Anemia of Chronic Disease (ACD).
This assay may also be used in conjunction with a ferritin measurement to provide a calculated sTfR/log ferritin index. This index is intended as an aid in the diagnosis of IDA, and for the differential diagnosis of IDA and ACD.
The Access sTfR Calibrators are intended to calibrate the Access sTfR assay for the quantitative determination of soluble transferrin receptor levels in human serum and plasma (heparin) using the Access Immunoassay Systems.
The Access sTfR QC is intended for monitoring system performance of the Access sTfR assay.
The Access sTfR reagent, calibrators, controls, and the Access Immunoassay Analyzers (Access, Access 2, Synchron LXi 725, UniCel DxC 600i, UniCel Dxl 600, and UniCel Dxl 800) comprise the Access Immunoassay Systems for the quantitative determination of soluble transferrin receptor in human serum and plasma.
Automated; Paramagnetic particles coated with mouse monoclonal antibody against sTfR. Uses the same mouse monoclonal antibodies against sTfR in the capture phase and signal phase as the predicate device.
Utilizes dioxetane-based chemiluminescent substrate; measures light production from a chemiluminescent reaction.
Calibrators are comprised of natural sTfR at 6 levels (0, 3, 10, 30, 80, and 150 nmol/L) in a buffered matrix.
QCs are human sTfR provided as a liquid at 3 levels (~10, ~25, ~90 nmol/L) in a buffered matrix.
Here's an analysis of the provided text to fulfill your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance (Access sTfR) |
|---|---|---|
| Imprecision (Total precision) | ≤ 8% CV for concentrations > 9 nmol/L | 2.6 to 5.4% CV for samples > 9 nmol/L |
| Imprecision (Total precision) | < 0.72 nmol/L SD for concentrations < 9 nmol/L | 0.08 to 0.38 nmol/L SD for samples < 9 nmol/L |
| Imprecision (Within run precision) | Not explicitly stated, but generally lower than total precision | 1.6 to 5.2% CV for samples > 9 nmol/L |
| Imprecision (Within run precision) | Not explicitly stated, but generally lower than total precision | 0.04-0.22 nmol/L SD for samples ≤ 9 nmol/L |
| Analytical Sensitivity (Lowest detectable level) | Not explicitly stated, but should be distinguishably non-zero | < 0.05 nmol/L |
| Dilution Recovery (Mean recovery) | 100 ± 15% | Within 100 ± 15% |
| Dilution Recovery (Individual mean recovery) | At least 92% within 100 ± 20% | At least 92% within 100 ± 20% |
| Methods Comparison (Correlation with Predicate) | High correlation (e.g., r > 0.95 or similar) | r = 0.96 (y=0.8901X + 0.6853) |
| Analytical Specificity (Interference avoidance) | No significant interference from therapeutic drugs, similar compounds, or common contaminants | No significant interference from therapeutic drugs, similar compounds, bilirubin, total protein, hemoglobin, triglycerides, or rheumatoid factor (up to 850 IU/mL) |
| Reagent Stability (Opened) | Not explicitly stated, but ensures practical shelf-life | 28 days |
| Calibrator Stability (Opened) | Not explicitly stated, but ensures practical shelf-life | 90 days |
| Control Stability (Opened) | Not explicitly stated, but ensures practical shelf-life | 90 days |
| Calibration Curve Stability | Not explicitly stated, but ensures practical shelf-life | 28 days |
| Clinical Sensitivity (sTfR for IDA/ACD+IDA) | Optimized sensitivity with reasonable specificity | 86% sensitivity at 21 nmol/L cutoff |
| Clinical Specificity (sTfR for IDA/ACD+IDA) | Optimized specificity with reasonable sensitivity | 49.1% specificity at 21 nmol/L cutoff |
| Clinical Sensitivity (sTfR/log ferritin index for IDA/ACD+IDA) | Optimal sensitivity | 80.7% sensitivity at 14 cutoff |
| Clinical Specificity (sTfR/log ferritin index for IDA/ACD+IDA) | Optimal specificity | 82.5% specificity at 14 cutoff |
2. Sample Size Used for the Test Set and Data Provenance
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Methods Comparison (Analytical Study):
- Sample Size: 271 samples
- Data Provenance: Not explicitly stated, but implies clinical samples used for comparing the new assay to the predicate. The "External Site" suggests multiple locations.
- Retrospective/Prospective: Not specified.
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Clinical Studies (Clinical Trial):
- Sample Size: Not explicitly stated for the clinical trial itself, but implied to be sufficient to derive sensitivity and specificity values.
- Data Provenance: "Prospective multicenter clinical trial." This indicates data was collected forward-in-time from multiple clinical sites. The country of origin is not specified.
- Retrospective/Prospective: Prospective.
3. 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. For the clinical studies, "diagnosis of Iron Deficiency Anemia (IDA), and for the differential diagnosis of IDA and Anemia of Chronic Disease (ACD)" would typically involve clinical experts (e.g., hematologists, clinical pathologists), but the number and qualifications are not mentioned.
4. Adjudication Method for the Test Set
This information is not provided in the document. For clinical diagnoses used as ground truth, an adjudication process (e.g., consensus by multiple experts) is often used, but it's not detailed here.
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
There was no MRMC comparative effectiveness study described. This device is an in vitro diagnostic (IVD) assay for measuring a biomarker (sTfR), not an AI-powered image analysis or diagnostic aid that would assist human readers in interpreting images or other complex data. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply to this specific device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the studies described are for the device's standalone performance as an in vitro diagnostic assay. The "Access sTfR reagents, calibrators, controls, and the Access Immunoassay Analyzers" perform the quantitative determination of sTfR levels. There isn't a human-in-the-loop component in the actual measurement and result generation of the sTfR value itself. The clinical interpretation of that sTfR result (and sTfR/log ferritin index) is then performed by a clinician.
7. The Type of Ground Truth Used
- Analytical Studies (Methods Comparison): The ground truth for method comparison was values obtained from the predicate device (Quantikine® IVD® sTfR ELISA). This is a common approach for demonstrating substantial equivalence for quantitative assays.
- Clinical Studies: The ground truth for the clinical study was the diagnosis of Iron Deficiency Anemia (IDA) and Anemia of Chronic Disease (ACD). This would typically be established through a combination of clinical assessment, laboratory tests (beyond just sTfR), and potentially bone marrow biopsy or response to iron therapy, which constitutes outcomes data or expert consensus-based clinical diagnosis. The document does not specify the exact methods for defining IDA and ACD beyond the general diagnoses.
8. The Sample Size for the Training Set
The document does not explicitly describe a "training set" in the context of an algorithm or machine learning model. This is an immunoassay (laboratory test), not a software/AI device that typically undergoes separate training and test phases.
- The "analytical studies" and "clinical studies" described serve as validation studies for the device's performance, much like a traditional device's verification and validation.
- There's no mention of a development phase where a model would be "trained" on a specific dataset.
9. How the Ground Truth for the Training Set Was Established
As there is no explicit "training set" mentioned in the context of typical machine learning, this question is not applicable. The development and optimization of the immunoassay reagents and protocols are based on scientific principles of immunology and chemistry, rather than an algorithmic training process on ground truth data.
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