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

Human IqA liquid reagent kit for use on SPAPLUS® comprises the following reagents:

Antiserum: Monospecific goat anti IgA supplied in stabilised liquid form. lt contains 0.099% sodium azide, 0.1% E-amino-n-caproic acid (EACA), 0.5% BSA and 0.01% benzamidine as preservatives.

Calibrator and Controls: These consist of pooled human serum and are supplied in stabilised liquid form. The concentration of IgA given on the quality control certificate has been obtained by comparison with European Reference Material ERM-DA470k. They contain 0.099% sodium azide, 0.1% EACA and 0.01% benzamidine as preservatives.

Reaction Buffer: Containing 0.099% sodium azide as a preservative.

The provided document describes the "Human IgA liquid reagent kit for use on SPAPLUS" by The Binding Site Group Ltd. This device is intended for the quantitative in vitro determination of human IgA in serum, lithium heparin, or EDTA plasma using the Binding Site SPAPLUS turbidimetric analyzer. The submission is a special 510(k) for a modification to an existing device (K103824), specifically a change in the source of the detection antibody from sheep to goat.

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 present acceptance criteria in a dedicated table format with corresponding reported device performance for all aspects. Instead, acceptance criteria are described within the context of each study and then a conclusion about meeting those criteria is stated. I will extract and present this information in a table format where possible.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Precision Studies:
  • Repeatability and Within Laboratory: 4 different samples, 80 data points for each level (total 320 data points).
  • Between Instrument: 4 different samples, 24 data points for each level (total 96 data points).
  • Between Lot: 4 different samples, 24 data points for each level (total 96 data points).
• Linearity Study: A high pool (8.19g/L) and a low pool (0.12 g/L) were used to create a dilution series. Each diluted sample was tested in 3 replicates.
• Accelerated Stability: 6 replicates of controls, internal reference, and 3 different samples were tested.
• Limit of Quantitation (LoQ) Validation: 4 samples were tested using two reagent lots.
• Method Comparison with Predicate Device: 102 serum samples and 42 plasma samples (total 144 samples).
• Expected Values/Reference Range Transfer: 20 samples from "apparently healthy US donors".

Data Provenance:

• For the Expected Values/Reference Range Transfer study, samples were from "apparently healthy US donors".
• For other studies, the country of origin or whether the data was retrospective or prospective is not explicitly stated. The studies were carried out by The Binding Site Group Ltd., which is based in the UK, so it's likely testing was conducted there unless otherwise specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This product is an in vitro diagnostic (IVD) reagent kit for quantitative Immunoglobulin A (IgA) determination. The "ground truth" in this context refers to the accurate measurement of IgA concentration. The document mentions traceability to European Reference Material ERM-DA470k/IFCC for calibration. This implies that the standard itself serves as the "ground truth" reference, rather than independent expert consensus on clinical interpretation. There are no mentions of experts establishing ground truth in the sense of clinical diagnosis or image interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective interpretation by multiple human readers (e.g., in radiology studies) to resolve discrepancies and establish a consensus "ground truth." Since this device is a quantitative IVD assay and its performance is validated against analytical standards, reference materials, and comparative measurements, such adjudication methods are not applicable and therefore not used.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic tools where human readers (e.g., radiologists) use AI assistance to improve their diagnostic accuracy. This device is a standalone quantitative laboratory test kit, not an AI or imaging diagnostic aid, so an MRMC study is not applicable.

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

Yes, the performance studies described are for the standalone device (reagent kit on the SPAPLUS analyzer) without human-in-the-loop performance influencing the measurement part of the device's function. The analytical performance, stability, and comparison studies evaluate the kit's ability to accurately measure IgA concentrations. The device's output is a quantitative value, not an interpretation of data that requires human feedback for performance assessment.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth for this quantitative assay is primarily based on:

• Reference Materials: Calibration traceability to ERM-DA470k/IFCC. This is the international standard for immunoglobulin measurements.
• Reference Methods: The predicate device itself (K103824) serves as a comparative "ground truth" for method comparison studies, demonstrating substantial equivalence.
• Defined Concentrations: For linearity and precision studies, samples with known or precisely diluted concentrations are used.
• Clinical Reference Intervals: The ability to transfer established reference intervals (based on a healthy population) is also part of the "ground truth" for clinical usability.

8. The sample size for the training set

This document describes a special 510(k) submission for a modification to an existing device, which mostly involves re-validation studies to ensure the modification (change in antibody source from sheep to goat) does not alter performance compared to the cleared predicate. It does not describe the development of a novel algorithm or AI model that requires a distinct "training set." The studies performed are validation studies, not training. Therefore, a "training set" in the context of machine learning is not applicable here.

9. How the ground truth for the training set was established

As there is no "training set" in the machine learning sense for this device submission, this question is not applicable. The device's underlying principles (immunoturbidimetry) are well-established, and its performance is validated against analytical standards rather than learned from a dataset.

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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

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