(110 days)
This product permits the quantitative in vitro diagnostic determination of Immunoglobulin A in serum and plasma on the ILab Clinical Chemistry System by turbidimetric immunoassay method. Measurement of IgA aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
quantex IgA: 8 x 6 mL anti-human IgA P/N 3000-22133; 2 x 100 mL Buffer P/N 3000-22130
This document is a 510(k) summary for a medical device called "quantex IgA" and does not contain the detailed information necessary to complete the requested table and study description. It is focused on demonstrating substantial equivalence to a predicate device rather than providing extensive performance data against pre-defined acceptance criteria.
However, based on the provided text, I can extract some limited information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| (Not explicitly stated in terms of specific thresholds for accuracy, precision, etc.) | Correlation (r) of 0.9905 with the predicate device (IL Test™ IgA) |
2. Sample size used for the test set and the data provenance
- Sample size: 45 serum samples
- Data provenance: Not specified (e.g., country of origin, retrospective/prospective). It mentions "serum samples," implying human origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This device measures a quantitative biomarker (IgA levels), and the "ground truth" for method comparison is typically considered the result from an established, predicate method, not a subjective expert assessment.
4. Adjudication method for the test set
- Not applicable. As this is a quantitative measurement compared to a predicate device, adjudication by experts for discrepancies is not relevant.
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
- No. This is a clinical chemistry assay for measuring IgA levels, not an imaging or diagnostic AI device that involves human reader interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Yes, implicitly. The device (quantex IgA on an ILab Clinical Chemistry System) independently measures IgA levels. The performance evaluated against the predicate device is a standalone comparison.
7. The type of ground truth used
- The "ground truth" for the comparative performance study was the measurements obtained from the predicate device (IL Test™ IgA on a Monarch Clinical Chemistry System).
8. The sample size for the training set
- Not applicable. This document describes a traditional in vitro diagnostic device, not a machine learning or AI-based device that typically has a "training set."
9. How the ground truth for the training set was established
- Not applicable.
Summary of Limitations of the Provided Text:
The provided 510(k) summary is designed to establish substantial equivalence, not to detail internal validation studies with explicit acceptance criteria for performance metrics like precision, linearity, limits of detection, etc., or to provide a "study that proves the device meets the acceptance criteria" in that sense. It focuses on the correlation with a legally marketed predicate device as the primary evidence of performance.
§ 866.5510 Immunoglobulins A, G, M, D, and E immunological test system.
(a)
Identification. An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.(b)
Classification. Class II (performance standards).