Search Results

ImmunoCAP Rapid Reader, part of ImmunoCAP Rapid System, is an instrument including software to be used for reading and scoring ImmunoCAP Rapid assay results. It is intended for in vitro diagnostic use and is to be used in clinical laboratories, licensed under CLIA to perform non-waived assays.

The ImmunoCAP® Rapid Reader is part of ImmunoCAP® Rapid System, which is a combination of lateral flow immunoassay reagents and instrument/software for semi-quantitative determination of IgE antibodies in human capillary whole blood, heparinized venous whole blood or heparinized plasma. The Rapid Reader is a stand alone instrument to be used with ImmunoCAP Rapid Assay Device. It consists of the Rapid Reader instrument and associated software. The user interface consists of a LCD display with a touch screen and a slot for insertion of the ImmunoCAP Rapid Assay Device. The Reader includes functions for photometric reading and scoring of the test results. The Assay Device is illuminated with white color spectrum LED's. A sensor records an image of the Assay Device including Test and Control Windows, and reads the color saturation (Color Units).

Here's a breakdown of the acceptance criteria and study detailed in the provided 510(k) decision summary:

Acceptance Criteria and Device Performance

The core acceptance criterion for the ImmunoCAP Rapid Reader is that its performance in reading IgE antibody levels is in agreement with the predicate device (ImmunoCAP Rapid Reader, K081830). This agreement is quantitatively measured by Overall Agreement Percentage, Negative Percent Agreement (NPA), and Positive Percent Agreement (PPA) between the new and predicate device readings.

Table of Acceptance Criteria and Reported Device Performance

Explanation of Performance Metrics:

• Overall Agreement %: The percentage of cases where the new device and the predicate device yield the same semi-quantitative class score for a given allergen.
• Negative Percent Agreement (NPA) %: The percentage of cases where both devices correctly identify the absence of IgE antibodies (i.e., Class 0 or below a certain threshold, corresponding to a "negative" result in a semi-quantitative context).
• Positive Percent Agreement (PPA) %: The percentage of cases where both devices correctly identify the presence of IgE antibodies (i.e., any positive class like Class 1, 2, or 3).
• Precision (Total CV%): This measures the reproducibility and repeatability of measurements. A lower CV% indicates higher precision.
• Limit of Blank (LoB): The highest measurement result that is likely to be observed for a blank sample (one containing no analyte).
• Limit of Detection (LoD): The lowest quantity of analyte that can be distinguished from the absence of that analyte with a stated confidence level.

Study Details

The primary study conducted was a Method Comparison study to demonstrate agreement with the predicate device.

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

• Whole Blood Comparison Study:
  • Sample Size: 134 donors (resulting in 1340 measurements across 10 allergens).
  • Data Provenance: Heparinized capillary whole blood collected from 134 donors. The country of origin is not explicitly stated, but "in-house plasma samples" in the next section suggests it was likely internal to the manufacturer's region or facilities. The study design (collecting new samples and testing on both devices) indicates this was a prospective comparison for the purpose of this submission, although the samples themselves were subject to immediate testing.
• Plasma Comparison Study:
  • Sample Size: 239 sensitized donors (resulting in 2390 measurements across 10 allergens).
  • Data Provenance: "In-house plasma samples from 239 sensitized donors." The retrospective or prospective nature of these samples is not explicitly stated beyond being "in-house," but the testing on both new and predicate devices for comparison marks this as a prospective comparison study for the device.

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

• Not applicable. The "ground truth" for the method comparison study was the predicate device's measurement. There were no human experts establishing a separate ground truth for the semi-quantitative classification of IgE levels; the comparison was directly between the new and predicate instrument readings.

4. Adjudication Method for the Test Set:

• Not applicable. Since the ground truth was the predicate device's reading, no human adjudication was performed or described. The comparison was a direct measurement comparison between two instruments.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No. This was a method comparison study between two instruments (new device vs. predicate device), not a study comparing human reader performance with and without AI assistance. The device itself is an automated reader, eliminating a human-in-the-loop component for the reading process.
• A precision study was performed involving 3 different Readers reading the same pre-prepared Assay Device 30 times each. This assessed inter-reader variability but wasn't an MRMC study in the context of comparative effectiveness with human interpretation.

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

• Yes. The primary performance data (method comparison, precision, LoB/LoD) are all standalone performance of the ImmunoCAP Rapid Reader. The device is designed to automatically read and score the assay results without human intervention in the interpretation process.

7. The Type of Ground Truth Used:

• The "ground truth" for the method comparison study was the semi-quantitative class scores generated by the predicate device (ImmunoCAP Rapid Reader, K081830).

8. The Sample Size for the Training Set:

• The document does not explicitly describe a separate "training set" in the context of a machine learning algorithm. The ImmunoCAP Rapid Reader's software performs calculations to convert Color Units to Class scores. This process likely involves pre-defined thresholds and algorithms rather than a dynamically trained machine learning model in the contemporary sense. Therefore, information on a training set size for an AI/ML model is not provided and likely not applicable in the way it would be for modern AI-driven image analysis. The reader is calibrated at manufacturing.

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

• As a training set for a machine learning algorithm is not explicitly mentioned, the method for establishing its "ground truth" is not applicable/provided. The operational principle relies on photometric reading and conversion of Color Units to Class scores using built-in software, likely based on established reference values or a lookup table, rather than a learned truth from a labeled training dataset.

Ask a specific question about this device

ImmunoCAP Rapid Inhalant Profile 1, part of the ImmunoCAP Rapid System, is an in vitro semi-quantitative assay for measurement of allergen specific IgE to ten inhalant allergens (house dust mite, cat, dog, mold, and pollen from common ragweed, Bermuda grass, timothy grass, oak, and elm) in heparinized human capillary whole blood, heparinized venous whole blood, or heparinized plasma. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings, and is to be used in clinical laboratories, licensed under CLIA to perform nonwaived assays.

ImmunoCAP Rapid System is a combination of lateral flow immunoassay reagents and instrument/software for semi-quantitative determination of antibodies or antigens in human capillary whole blood, heparinized venous whole blood or heparinized plasma.

ImmunoCAP Rapid System currently consists of the following:

• ImmunoCAP Rapid Inhalant Profile 1 a kit for measuring specific IgE antibody . levels to 10 inhalant allergens (house dust mite, cat epithelium and dander, dog dander, mold, and pollen from common ragweed, Bermuda grass, timothy grass, oak, and elm).
• · ImmunoCAP Rapid Reader an instrument for reading and scoring the test results.
• ImmunoCAP Rapid Reader Check Device an external positive and negative Reader . control for regular checks of instrument performance.
• ImmunoCAP Rapid QC 1 a kit containing external positive and negative specific IgE . system controls to be performed with recommended frequency.

The Phadia ImmunoCAP® Rapid System, specifically ImmunoCAP® Rapid Inhalant Profile 1, is an in vitro semi-quantitative assay for measuring allergen-specific IgE antibodies to ten inhalant allergens.

Here's an analysis of its acceptance criteria and the study that proves it meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: 245 donors were included in the comparison studies.
• Data Provenance: Not explicitly stated, but given it's a 510(k) submission from a Swedish company (Phadia AB) with a US distributor, the data likely comes from studies conducted to meet international regulatory standards. It's retrospective in the sense that samples were collected and then tested. The summary implies a controlled study rather than real-world retrospective data collection.

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

• This information is not provided in the summary. The "ground truth" for the test set is established by the Predicate Device (ImmunoCAP Specific IgE) results, which themselves are an established diagnostic method. The summary does not mention separate expert reconciliation or adjudication for defining the "true" IgE levels beyond what the predicate device provides.

4. Adjudication Method for the Test Set

• This information is not provided. The comparison is directly between the New Device and the Predicate Device. There is no mention of an external adjudication process for the test results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study, in the sense of human readers interpreting findings with and without AI assistance, was not done. This device is a diagnostic assay that outputs a semi-quantitative class (1, 2, or 3) for specific IgE levels, not an image interpretation system.

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

• The performance described is essentially standalone performance for the device. The ImmunoCAP Rapid Reader is an instrument that "reads and scores the test results" as Class 1, 2, or 3. The studies assess the accuracy and consistency of this automated reading process against a predicate device, without involving human interpretation of the rapid test results influencing the final determination.

7. The Type of Ground Truth Used

• The ground truth for evaluating the ImmunoCAP Rapid System was established by the Predicate Device: ImmunoCAP® Specific IgE laboratory test. This predicate device is itself a legally marketed and established method for measuring allergen-specific IgE. Therefore, the "ground truth" is a benchmark against an accepted, existing diagnostic tool.

8. The Sample Size for the Training Set

• The document does not specify a separate training set. The "comparison studies" involving 245 donors are described as the performance testing for the device. For an in vitro diagnostic (IVD) assay like this, "training set" might not be defined in the same way as for AI/ML algorithms. The assay's parameters would have been developed and optimized during its R&D phase, but a distinct "training set" linked to this submission is not mentioned.

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

• Since a specific "training set" and its ground truth are not explicitly described in this summary, the method for establishing its ground truth is also not provided. The development and optimization of the assay would typically involve using samples with known IgE levels (often characterized by reference methods or validated predicate devices) to establish optimal reagent concentrations, reading algorithms, and cut-offs for the different classes.

Ask a specific question about this device

The Rapid Reader System is designed to read , capture, document and archive ABMC's Rapid Drug Screen®, Rapid One®, and Rapid TEC® screening immunoassays ("ABMC test"). The Rapid Reader is used to obtain qualitative results (equivalent to manual read test results) and is intended for professional and point of care use only. It is not intended for over the counter sale to non-professionals. This Reader, combined with ABMC tests is a simplified qualitative screening method that provides only a preliminary result for use in determining the need for additional or confirmatory testing, i.e., gaschromatography/mass spectrometry (GC/MS).

The Rapid Reader System is a reader designed to capture, document and archive ABMC Drug of abuse test results using Rapid Drug Screen®, Rapid One®, and Rapid TEC® screening immunoassays ("ABMC tests"). The Rapid Reader is used to obtain qualitative results and is intended for professional use only. This Reader, combined with ABMC tests is a simplified qualitative screening method that provides a preliminary indication of drugs in urine. Results should be confirmed using appropriate confirmation methods. i.e., gas-chromatography/mass spectrometry (GC/MS).

The Rapid Reader utilizes a digital camera, pictures are analyzed using software algorithm developed to read any of American Bio Medica Corporation's (ABMC's) drugs of abuse screening immunoassays. These immunoassays include the Rapid Drug Screen®, Rapid One®, or Rapid TEC® drug of abuse test for the simultaneous detection of up to 10 drugs of abuse in human urine. All of these tests have been previously FDA cleared as Class II devices.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

Study Details:

• Sample size used for the test set and the data provenance: Not explicitly stated. The text mentions "Certified negative and positive controls for each of the 14 drugs of abuse were tested," suggesting a set of controlled samples. The provenance (country of origin, retrospective/prospective) is not specified, but the study inherently appears prospective in nature as it describes an evaluation being conducted.

• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Three "untrained professionals" performed the manual interpretation which served as the reference for comparison. Their specific qualifications beyond "untrained professionals" are not provided.

• Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not explicitly stated, but the process implies direct comparison of the Rapid Reader's output to the manual interpretation by the three "untrained professionals." It's not clear if there was a formal adjudication process if these three professionals disagreed amongst themselves.

• 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, in the typical sense of measuring human reader improvement with AI assistance, was not performed. This study compared the device (Rapid Reader) against manual human interpretation, not human readers with and without AI assistance.

• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Yes, the described study is a standalone performance evaluation. The Rapid Reader generated results independently, which were then compared to human manual interpretation.

• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth was established by "manual interpretation (human eye interpretation)" performed by three "untrained professionals," combined with the use of "certified negative and positive controls" for each drug. This is a form of expert consensus/reference standard.

• The sample size for the training set: Not provided. The document focuses exclusively on the performance evaluation of the Rapid Reader, not its development or training data.

• How the ground truth for the training set was established: Not provided.

Ask a specific question about this device