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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.

The table clearly shows that the modified device's performance metrics are either improved (e.g., lower LoD, LoQ, extended stability) or remain comparable to the predicate device, demonstrating that the device meets or exceeds the previous performance. The linearity range was expanded downwards from 25.0 to 20.0 IU/mL. The precision values reported for the subject device are well within the specified acceptance criteria for the predicate.

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

The document provides sample sizes for various analytical validation studies:

• Sample Matrix Comparison:
  • Predicate device: Five sets of 52 paired samples were run (total 260 samples).
  • Subject device: Forty paired samples were run (serum vs. various plasma types).
• Limit of Blank (LoB), Limit of Detection (LoD), Limit of Quantitation (LoQ):
  • LoB: n ≥ 60 replicates of zero-analyte samples.
  • LoD: n ≥ 60 replicates of low-analyte level samples.
  • LoQ: n ≥ 60 replicates of low-analyte level samples.
• Precision:
  • Control (Level I, Mixture I&II, Level II): 50 replicates each (for predicate data summary).
  • Subject device: 80 replicates for "Panel 50 IU/mL", "Control I", "1:1 Mix Control I and II", "Control II", "Panel 800 IU/mL" (tested in a minimum of 2 replicates, twice per day on 20 days).
  • Additionally, 3 native serum pools (Panel A, B, C) were tested with 48 replicates each (in a minimum of 2 replicates, twice per day on 12 days).

Data Provenance: The document does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective. However, based on the nature of analytical validation studies for an in-vitro diagnostic device, these are typically prospective laboratory studies conducted at the manufacturer's R&D facilities or contracted labs.

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

For an in-vitro diagnostic (IVD) device like Quantia IgE, the ground truth for performance evaluation (e.g., linearity, LoD, LoQ, precision, matrix effects) is established through analytical reference methods and calibrated standards, not human expert review. These studies rely on precise laboratory measurements and established protocols (e.g., CLSI guidelines). Therefore, there are no "experts" in the sense of radiologists reviewing images to establish ground truth.

4. Adjudication Method for the Test Set

Not applicable for analytical performance studies of an IVD. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies, particularly for diagnostic imaging or subjective assessments, where human agreement on a diagnosis or finding is crucial. Here, the values are quantitative measurements compared to reference values or statistical criteria.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This device is an in-vitro diagnostic assay for measuring total IgE levels, not an imaging device or AI-assisted diagnostic tool that would involve human readers interpreting results. Therefore, an MRMC study is irrelevant to its validation.

6. Standalone (Algorithm Only) Performance

This entire submission describes the standalone performance of the Quantia IgE assay, a laboratory test. It is not an "algorithm" in the typical sense of AI, but rather a biochemical assay system. All performance metrics described (linearity, LoD, LoQ, precision, etc.) are characteristics of the assay system itself, without human interpretation beyond standard laboratory procedures and result reporting.

7. Type of Ground Truth Used

The ground truth used for these analytical performance studies is based on:

• Reference Standards/Calibrators: For linearity, LoD, LoQ, and IgE International Standard Recovery, the ground truth is established by using highly characterized, traceable calibrators and reference materials with known concentrations.
• Statistical Definitions/Methodologies: The definitions for LoB, LoD, and LoQ explicitly state how they are determined using a certain number of replicates of zero-analyte or low-analyte samples, and statistical calculations (e.g., 95th percentile, mean + 2 SD).
• Established CLSI Protocols: The studies explicitly state that they were performed based on guidance from CLSI (Clinical and Laboratory Standards Institute) protocols, such as NCCLS EP6-A (now EP06), EP17-A2, EP07-A2, EP37, and EP05-A3. These protocols outline the scientifically accepted methods for establishing analytical performance characteristics.

8. Sample Size for the Training Set

This document describes a "Special 510(k)" for a modification to an existing device (Quantia IgE) to demonstrate substantial equivalence. For IVD analytical performance studies, there isn't a "training set" in the machine learning sense alongside a "test set." The studies performed are the analytical validation studies on actual samples or controls covering the relevant range. The sample sizes for these studies are provided above (e.g., 40 paired samples for matrix comparison, ≥60 replicates for LoD/LoQ, 80 replicates for precision controls, 48 for native serum panels).

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

As explained under points 3 and 7, the concept of a "training set" and "ground truth established by experts" for this type of device and study is not directly applicable. The "training" for such an IVD device happens during its development and optimization phases, where various reagent formulations and assay parameters are tested against known concentration panels to achieve optimal performance. The "ground truth" during this development is based on the known concentrations of calibrators and reference materials, and the adherence to established analytical performance standards. The studies detailed in this 510(k) summary are the formal validation (test set) of the modified device's performance.

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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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