(41 days)
The Immunoglobulin A assay is used for the quantitation of immunoglobulin A in human serum or plasma. Measurement of immunoglobulin A aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
Immunoglobulin A is an in vitro diagnostic assay for the quantitative determination of immunoglobulin A in human serum or plasma. Antigen in the sample bonds to the specific antibody in the reagent, forming an immune complex. The immune complex causes an increase in light scattering, measured by reading turbidity at 700 nm, which correlates with the concentration of immunoglobulin A in the sample.
This document describes the Abbott Laboratories Immunoglobulin A (IgA) assay, an in vitro diagnostic device. The study presented focuses on demonstrating substantial equivalence to a predicate device rather than setting new acceptance criteria based on novel clinical outcomes.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (from Predicate Device) | Reported Device Performance (IgA assay) |
|---|---|---|
| Correlation Coefficient | Not explicitly stated, but "acceptable correlation" to predicate. | 0.9879 with K-ASSAY Immunoglobulin A assay |
| Slope | Not explicitly stated, but "acceptable correlation" to predicate. | 1.006 with K-ASSAY Immunoglobulin A assay |
| Y-intercept | Not explicitly stated, but "acceptable correlation" to predicate. | -0.404 mg/dL with K-ASSAY Immunoglobulin A assay |
| Total %CV (Precision) | Not explicitly stated, but "precision studies were conducted... using two levels of control material." | Level 1/Panel 401: 1.5% |
| Level 2/Panel 402: 2.4% | ||
| Assay Range | Not explicitly stated, but comparison is made. | 0.566 to 797.44 mg/dL |
| Limit of Quantitation (Sensitivity) | Not explicitly stated, but comparison is made. | 0.566 mg/dL |
2. Sample Size and Data Provenance
The document does not specify the exact sample size used for the comparative performance studies (method comparison and precision studies). It mentions "two levels of control material" for precision studies, but not the number of replicates or runs for each. The data provenance is not explicitly stated (e.g., country of origin, retrospective or prospective), but it is implied to be from internal studies conducted by Abbott Laboratories for the purpose of this 510(k) submission.
3. Number of Experts and Qualifications
Not applicable. This is an in vitro diagnostic assay, and the ground truth is established through laboratory methods and comparison to a legally marketed predicate device, not through expert human review of images or clinical cases.
4. Adjudication Method
Not applicable. This is an in vitro diagnostic assay.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is an in vitro diagnostic assay, not a medical imaging or diagnostic aid device that involves human readers.
6. Standalone Performance
Yes, a standalone performance was done. The IgA assay's performance characteristics (correlation, precision, assay range, sensitivity) were evaluated independently on the AEROSET™ System against the K-ASSAY® Immunoglobulin A assay run on the Hitachi® 717 Analyzer. This is a comparison of two analytical methods, effectively demonstrating the standalone performance of the new device relative to the predicate.
7. Type of Ground Truth Used
The ground truth for the comparative performance study was established by the K-ASSAY® Immunoglobulin A assay on the Hitachi® 717 Analyzer, which is the legally marketed predicate device. This is a form of comparative analytical performance against an established method.
8. Sample Size for the Training Set
Not applicable. This is a chemical assay, and the "training set" concept (as it pertains to machine learning algorithms) does not apply here. The device's performance is based on its inherent chemical and optical properties and established analytical protocols.
9. How Ground Truth for the Training Set Was Established
Not applicable for the same reason as point 8. The device operates based on established laboratory principles, not a learned algorithm from a training set. The performance is validated through comparison to a well-established and legally marketed predicate device.
§ 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).