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Automated latex enhanced immunoassay for the quantitative in vitro determination of total immunoglobulin E (1gE) in human serum or plasma (EDTA, heparin, citrate) using the ARCHITECT c Systems. The measurement of total IgE is useful in the clinical diagnosis of IgE-mediated allergies, if used in conjunction with other clinical studies.

The Quantia IgE reagent is a suspension of polystyrene latex particles of uniform size coated with mouse anti-human IgE. When a sample containing IgE is mixed with the latex reagent and the reaction buffer included in the kit, agglutination occurs. The degree of agglutination is directly proportional to the concentration of IgE in the sample and is determined by measuring the decrease of transmitted light caused by the aggregates. Methodology: Turbidimetric/Immunoturbidimetric.

The provided document outlines the acceptance criteria and study results for the Quantia IgE assay, a device for quantitatively determining total IgE in human serum or plasma. It's important to note that this document is a 510(k) summary, focusing on demonstrating substantial equivalence to a predicate device after a modification, rather than a comprehensive de novo approval study. Therefore, some information typically found in a de novo clinical trial report (e.g., specific details on training set size, number of experts for training ground truth) might not be explicitly detailed.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by the performance characteristics presented and their comparison to the predicate device or established clinical standards (e.g., CLSI guidelines). The document focuses on demonstrating that the modified device performs as well as the predicate and meets relevant analytical performance metrics.

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Quantia IqE is intended as a latex particle enhanced immunoturbidimetric assay for the in vitro quantitative determination of Immunoglobulin E concentration in human serum or plasma (EDTA, heparin, citrate) on the AEROSET System. Measurement of IgE is useful in the clinical diagnosis of IgE-mediated allergies, if used in conjunction with other clinical studies.

Quantia Ferritin / Myoglobin / IgE control is intended for use in monitoring the quality control of results obtained with Quantia Ferritin, Quantia Myoglobin and Quantia IgE reagents by turbidimetry. (NOTE: These controls were previously FDA cleared for use with quantex Ferritin, reference K040879 and also cleared for use with quantex Myoglobin K042982). For in vitro diagnostic use.

Quantia IgE Standard is intended for use in establishing the calibration curve for the Quantia IgE reagents by turbidimetry. For in vitro diagnostic use.

Quantia IgE is intended as a latex particle enhanced immunoturbidimetric assay for the in vitro quantitative determination of Immunodobulin E concentration in human serum or plasma (EDTA, heparin, citrate) on the AEROSET System. Measurement of IgE is useful in the clinical diagnosis of IgE-mediated allergies, if used in conjunction with other clinical studies.

Quantia Ferritin / Myoglobin / IgE control is intended for use in monitoring the quality control of results obtained with the Quantia Ferritin, the Quantia Myoglobin and the Quantia IgE reagents by turbidimetry. (NOTE: These controls were previously FDA cleared for use with quantex Ferritin. reference K040879 and also cleared for use with quantex Myoglobin K042982) For in vitro diagnostic use.

Quantia IgE Standard is intended for use in establishing the calibration curve for the Quantia IgE reagents by turbidimetry. For in vitro diagnostic use.

Here's a breakdown of the acceptance criteria and the study information for the Quantia IgE device based on the provided text:

Acceptance Criteria and Reported Device Performance

The document implies acceptance criteria by demonstrating substantial equivalence to the predicate device. The key performance indicators used for this determination are related to method comparison and precision.

Study Details

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: 101 samples
   • Data Provenance: Not explicitly stated (e.g., country of origin). The study involved evaluating IgE levels ranging from 10 to 2269 IU/mL. It is likely retrospective, comparing an existing set of samples against two different assays.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable for this type of in vitro diagnostic device study. The "ground truth" for the method comparison is the measurement obtained from the predicate device.

3. Adjudication method for the test set:

   • Not applicable. This is a quantitative assay comparison, not an interpretation-based study requiring adjudication.

4. 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, an MRMC comparative effectiveness study was not done. This is an in vitro diagnostic device measuring a biomarker, not an imaging or interpretive AI system involving human readers.

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

   • Yes, this study represents a standalone performance evaluation of the Quantia IgE assay (an algorithm in the sense of an automated test system) as it directly measures IgE levels and compares them to a predicate device without human intervention in the measurement process itself.

6. The type of ground truth used:

   • For the method comparison study, the measurement obtained from the UniCAP Total IgE Fluoroimmunoassay (K964152) was used as the reference or "ground truth" for comparison. The precision study used known control materials.

7. The sample size for the training set:

   • Not applicable as this is not a machine learning / AI model that requires a discrete training set. The "training" for such a system would involve the assay's development and optimization, which isn't described in terms of a specific data set size here.

8. How the ground truth for the training set was established:

   • Not applicable for the reason stated above.

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