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510(k) Data Aggregation
(39 days)
Access Intrinsic Factor Ab
The Access Intrinsic Factor Ab assay is a paramagnetic particle, chemiluminescent immunoassay for the detection of intrinsic factor antibody in human serum and plasma using the Access Immunoassay Systems.
It is intended for in vitro diagnostic use as an aid in the diagnosis of pernicious anemia.
The Access Intrinsic Factor Ab assay is a competitive binding immunoenzymatic assay. The Access assay consists of the reagent pack, calibrators and QCs. Other items needed to run the assay include substrate and wash buffer. The Access assay reagent pack, Access assay calibrators, Access QCs, along with the UniCel Dxl Wash Buffer II are designed for use with the Dxl 9000 Access Immunoassay Analyzer in a clinical laboratory setting.
The acceptance criteria and device performance information provided in the document focuses on the Access Intrinsic Factor Ab assay's performance on the Dxl 9000 Access Immunoassay Analyzer compared to the Access 2 Immunoassay System (predicate device).
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" as a separate table, but it provides performance metrics that would serve as the basis for such criteria, particularly for method comparison and imprecision. The comparison is against an existing predicate device, implying that performance should be comparable or non-inferior.
| Performance Metric | Acceptance Criteria (Implied/Derived from context) | Reported Device Performance (Access Intrinsic Factor Ab on Dxl 9000) |
|---|---|---|
| Method Comparison | Agreement with predicate device (Access 2 Immunoassay System) for Negative, Positive, and Total Agreement. (Specific thresholds are not explicitly stated, but high agreement is expected for substantial equivalence). | Negative Agreement: 100% (39/39) |
| Positive Agreement: 97.5% (78/80) | ||
| Total Agreement: 96.9% ((39 + 78 + 7) / 128) | ||
| Within-Laboratory Imprecision (Total CV) | CV ≤ 10.0% | Sample 1 (Mean 1.0 AU/mL): 4.2% |
| Sample 2 (Mean 1.3 AU/mL): 4.3% | ||
| Sample 3 (Mean 1.5 AU/mL): 3.9% | ||
| Sample 4 (Mean 1.6 AU/mL): 4.4% | ||
| Sample 5 (Mean 3.4 AU/mL): 3.7% | ||
| Sample 6 (Mean 14 AU/mL): 3.3% | ||
| (All reported Total CVs are ≤ 10.0%) |
2. Sample Size and Data Provenance
- Test Set Sample Size:
- Method Comparison: 128 serum samples.
- Imprecision Study: For each of the 6 samples tested, N=80 measurements were performed (implying 80 duplicate measurements over 20 days or similar).
- Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be prospective analytical validation studies conducted by the manufacturer, Beckman Coulter, Inc.
3. Number and Qualifications of Experts for Ground Truth
This information is not provided in the document. The studies described are analytical performance validations comparing a new instrument platform to an existing one, and assessing precision. They do not involve human expert interpretation of images or other subjective data for ground truth establishment. The ground truth for the method comparison is the result obtained from the predicate device (Access 2 Immunoassay System), which itself is a quantitative assay.
4. Adjudication Method for the Test Set
This information is not applicable/provided. The studies focus on objective quantitative measurements (concentration levels, agreement with a predicate assay). There is no mention of subjective interpretation requiring adjudication by multiple readers or experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not applicable/provided. The device is an in vitro diagnostic immunoassay, not an imaging AI device that would typically involve human reader evaluation or assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This information is not applicable. The device is an immunoassay system, not an AI algorithm. Its performance is inherent to the assay and instrument mechanics. The "standalone" performance is effectively what is reported in the method comparison and imprecision studies.
7. Type of Ground Truth Used
- For Method Comparison: The ground truth for evaluating the Access Intrinsic Factor Ab assay on the Dxl 9000 was the results obtained from the predicate device (Access Intrinsic Factor Ab assay on the Access 2 Immunoassay System). This is a comparative analytical performance study.
- For Imprecision: The ground truth is the measured concentration of the intrinsic factor antibody within the samples themselves, with variability around that measurement being assessed.
8. Sample Size for the Training Set
This information is not applicable/provided. As an immunoassay, the device does not employ machine learning or AI algorithms that would require a "training set" in the conventional sense. The "training" for such a system would involve optimizing the assay reagents and instrument parameters during development, not a data-driven training set for an algorithm.
9. How the Ground Truth for the Training Set was Established
This information is not applicable/provided for the same reasons as #8.
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