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The Optilite IgA Kit is intended for the quantitative in vitro measurement of IgA in serum, lithium heparin or EDTA plasma using the Binding Site Optilite analyser. Measurement of IgA aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. This test should be used in conjunction with other laboratory and clinical findings.

The Optilite IgA Kit comprises the following reagents: Antiserum: Goat anti IgA supplied in stabilised liquid form. Preservatives: 0.099% sodium azide, 0.1% E-amino-n-caproic acid (EACA), 0.5% BSA and 0.01% benzamidine. Calibrator and Controls: Pooled human serum, supplied in stabilised liquid form. Contain 0.099% sodium azide, 0.1% EACA and 0.01% benzamidine as preservatives. The concentration given on the quality control certificate has been obtained by comparison with the DA470k international reference material. Reaction Buffer: Containing 0.099% sodium azide as a preservative.

Here's a breakdown of the acceptance criteria and study detailed in the provided document for the Optilite IgA Kit, organized according to your requested information.

It's important to note that this document is a 510(k) summary for a modification to an existing device (Optilite IgA Kit, K103824). Therefore, the study presented here primarily focuses on confirming that the modified device (with a change from sheep to goat antibody) performs comparably to the predicate device (the original cleared kit) and that the performance characteristics detailed in the original submission still hold true. This is not a study to establish initial performance characteristics, but rather to demonstrate equivalence after a modification.

Acceptance Criteria and Device Performance Study for Optilite IgA Kit (K191985)

This study was conducted to demonstrate that the modified Optilite IgA Kit, with a change in the source of the detection antibody from sheep to goat, maintains comparable performance to the predicate device (Optilite IgA Kit, K103824). The acceptance criteria were primarily based on demonstrating no significant change in performance compared to the previously cleared device.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes Used for the Test Set and Data Provenance

• Precision (Repeatability & Within Laboratory): 5 different samples, N=80 per level (total 400 replicates).
• Precision (Between Instrument): 5 different samples, N=24 per level (total 120 replicates).
• Precision (Between Lot): 5 different samples, N=24 per level (total 120 replicates).
• Linearity: High pool (8.59 g/L) and low pool (0.10 g/L) for dilution series. Each diluted sample tested in 3 replicates.
• Kit Stability (Accelerated): 6 replicates of controls, internal reference, and samples.
• Detection Limit (LoQ): 4 samples tested using 2 reagent lots.
• Method Comparison: 102 serum samples, 42 plasma samples (total 144 samples). The document does not specify county of origin, but it is implied to be for US market. The study appears to be prospective as it's conducted to support a new submission for a modified device.
• Reference Range Transfer: 20 samples from apparently healthy US donors.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of in-vitro diagnostic device (measuring Immunoglobulin A levels in blood samples) does not typically involve human expert readers or a "ground truth" derived from expert consensus in the same way an imaging AI device would. The "ground truth" for the performance characteristics (precision, linearity, limits, comparison) is derived from:

• Reference materials: Traceability to ERM-DA470k/IFCC for calibration.
• Established analytical methods: Results from the predicate device serve as the comparative "reference."
• Pre-defined specifications: Acceptance criteria for analytical performance established based on regulatory guidelines (e.g., CLSI standards) and the performance of the predicate device.

Therefore, there is no mention of experts establishing ground truth for the test set in the conventional sense of human readers for an AI imaging study.

4. Adjudication Method for the Test Set

Not applicable for this type of in-vitro diagnostic analytical performance study. Adjudication by human experts is typically performed in clinical studies involving interpretation of data (e.g., imagery, patient symptoms) where subjective judgment might be involved. Here, the measurements are quantitative and based on instrument readings.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

No, an MRMC study was not done. This is an in-vitro diagnostic device that quantifies an analyte (IgA) in blood samples. MRMC studies are specific to imaging devices and human interpretation. This device does not involve human readers in its direct use or interpretation of results beyond a lab technician operating the instrument and a clinician interpreting the quantitative IgA values.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, the analytical performance studies (precision, linearity, detection limits, method comparison) represent the "standalone" performance of the analytical instrument and reagents. The device provides a direct quantitative measurement, so there isn't a human-in-the-loop directly assisting the measurement process itself, only interpreting the final numerical result.

7. The Type of Ground Truth Used

The ground truth for this device is based on:

• Quantitative Reference Materials: The calibration is traceable to an international reference material (ERM-DA470k/IFCC).
• Comparative Performance to Predicate Device: The performance of the predicate device (Optilite IgA Kit, K103824) serves as the established "truth" against which the modified device is compared to prove substantial equivalence.
• Analytical Standards: Established methods and guidelines (e.g., CLSI standards) define how analytical accuracy, precision, and other parameters are measured and what constitutes acceptable performance.
• Known Concentrations in Quality Control (QC) Materials: Pooled human sera with known concentrations are used for controls and calibrators, providing a known value against which measurements are assessed.

8. The Sample Size for the Training Set

This document describes a pre-market notification for a modified in-vitro diagnostic device; as such, it does not detail a "training set" in the context of machine learning or AI algorithm development. The "training" for such a system would typically refer to the initial development and optimization of the assay reagents and instrument parameters. The studies presented here are primarily verification and validation studies to demonstrate that the performance of the modified device is equivalent to the predicate. The specifics of the original assay development/optimization (which could be considered analogous to "training") are not provided here, as this is a 510(k) for a modification.

9. How the Ground Truth for the Training Set was Established

Not applicable in the context of this 510(k) for a modified in-vitro diagnostic device. As explained above, there isn't a "training set" in the machine learning sense. The "ground truth" for the development of the original assay would have involved rigorous biochemical and analytical characterization of the antibodies and their reaction with IgA, optimization of assay conditions (e.g., reagent concentrations, incubation times), and calibration against international reference standards.

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