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510(k) Data Aggregation
(69 days)
The ADVIA IMS Unsaturated Iron Binding Capacity (UIBC) assay is an in vitro diagnostic device intended to measure iron binding capacity in human serum and dlagmostly are new inding capacity are used in the diagnosis and treatment of anemias.
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The provided document describes a 510(k) summary for a new in vitro diagnostic device, the ADVIA® IMS™ Unsaturated Iron Binding Capacity (UIBC) method. The summary focuses on demonstrating substantial equivalence to a predicate device, the Technicon CHEM 1. Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state formal "acceptance criteria" in terms of predefined success thresholds (e.g., "CV must be < X%"). Instead, it presents performance data for the new device and the predicate device, implying that equivalence (or superior performance) to the predicate serves as the de facto acceptance benchmark for substantial equivalence.
| Performance Metric | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (ADVIA IMS) | Reported Predicate Performance (CHEM 1) |
|---|---|---|---|
| Imprecision (Total CV%) | Comparable to or better than predicate across different UIBC levels. | ||
| Level 48.0 ug/dL | N/A (predicate measured higher levels) | 10.6% | 5.3% (at 141 ug/dL) |
| Level 157/141 ug/dL | Comparable to CHEM 1 at 141 ug/dL (5.3%) | 3.4% | 5.3% |
| Level 537/559 ug/dL | Comparable to CHEM 1 at 559 ug/dL (4.5%) | 1.0% | 4.5% |
| Correlation (vs. Predicate) | High correlation (R close to 1) and low Syx with the predicate device. | R = 0.997, Syx = 7.86 ug/dL | N/A (ADVIA IMS vs. CHEM 1) |
| Regression Equation | Slope close to 1, intercept close to 0 (indicating good agreement). | Y = 0.96X - 8.76 | N/A |
| Correlation (Serum vs Plasma) | High correlation (R close to 1) and low Syx between serum and plasma samples. | R = 0.999, Syx = 3.04 ug/dL | N/A |
| Regression Equation | Slope close to 1, intercept close to 0. | Y = 0.99X - 1.70 | N/A |
| Interfering Substances | Effect (% change) should be acceptable for clinical use (no specific threshold stated, but implies minimal clinically significant interference). | N/A (Predicate data not shown for this) | |
| Bilirubin (unconjugated) | N/A | -10% | |
| Bilirubin (conjugated) | N/A | -5% | |
| Lipids (Triglycerides) | N/A | -69% | |
| Analytical Range | Should cover the clinically relevant range for UIBC. | 30 to 560 ug/dL | Not explicitly stated for predicate in summary |
Summary of Reported Device Performance:
- Imprecision: The ADVIA IMS showed lower Total CV% at higher UIBC levels (157 ug/dL and 537 ug/dL) compared to the CHEM 1 at comparable levels, indicating better precision. At the lower level, direct comparison is difficult due to different predicate concentration.
- Correlation (vs. CHEM 1): Very high correlation (R=0.997) and a low standard error of the estimate (Syx = 7.86 ug/dL) suggest strong agreement between ADVIA IMS and CHEM 1.
- Correlation (Plasma vs Serum): Excellent correlation (R=0.999) and low Syx (3.04 ug/dL) between plasma and serum samples on the ADVIA IMS, indicating that either sample type can be used.
- Interfering Substances: Bilirubin had a relatively small effect (-5% to -10%), but lipids (Triglycerides) showed a significant negative effect (-69%), which would require a cautionary note in the labeling.
- Analytical Range: 30 to 560 ug/dL is provided.
2. Sample sizes used for the test set and the data provenance
- Correlation (vs. Predicate):
- Sample Size: 58 Serum samples
- Data Provenance: Not explicitly stated (e.g., country of origin). It is retrospective as it compares the new device with an existing predicate using collected samples.
- Correlation (Serum vs Plasma):
- Sample Size: 50 samples (presumably collected concurrently to compare serum and plasma from the same individuals)
- Data Provenance: Not explicitly stated. Likely prospective for this specific comparison.
- Imprecision: Not specified, but typically involves repeated measurements of control samples or patient pools over several days.
- Interfering Substances: Not explicitly stated per substance, but involves specific concentrations of interferents added to samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This document describes the performance of an in vitro diagnostic (IVD) device that measures a specific analyte (UIBC) in a sample. The "ground truth" for such devices is established by reference methods or validated predicate devices, not by expert interpretation of images or other qualitative data. Therefore:
- Number of experts: Not applicable.
- Qualifications of those experts: Not applicable.
4. Adjudication method for the test set
Not applicable, as the "ground truth" is determined by quantitative measurements from validated methods/devices rather than human interpretation requiring adjudication.
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
Not applicable. This is an IVD device for laboratory measurement, not an AI-assisted diagnostic imaging or interpretation system involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the studies presented (Imprecision, Correlation, Interfering Substances, Analytical Range) represent the standalone performance of the ADVIA IMS device. This device functions as a laboratory analyzer, providing quantitative results directly from the sample without human intervention in the measurement process itself. The user interprets the numerical output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for this type of IVD device is based on recognized reference methods or the performance of a legally marketed predicate device.
- For the correlation study, the Technicon CHEM 1 (the predicate device) served as the reference for comparison of UIBC values.
- For imprecision, the "ground truth" is the true analytical variability inherent in the method when measuring known concentrations.
- For interfering substances, the "ground truth" is the UIBC concentration of samples without the interferent added.
8. The sample size for the training set
Not applicable for this type of IVD device. This device is based on chemical reactions and optical detection, not machine learning or artificial intelligence that requires a "training set."
9. How the ground truth for the training set was established
Not applicable, as no "training set" is used for this type of IVD device.
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