Search Results

Pharmacia CAP System IgE FEIA is an in vitro test system for the quantitative measurement of circulating total IgE antibodies in human blood samples.

Pharmacia CAP System IgE FEIA contains three separate units: IgE FEIA Fluoroenzymeimmuno reagents, IgE FEIA Standard reagents and Anti-IgE FEIA ImmunoCAP. The product update (Pharmacia CAP System IgE FEIA) consists of a modification of the antibodies in the Enzyme-Anti-IgE and Anti-IgE ImmunoCAP reagents. In Enzyme-Anti-IgE Modification: From a mix of rabbit antiserum/mouse monoclonal to only mouse monoclonal antibodies. In Anti-IgE ImmunoCAP Modification: From Antiserum raised in sheep to mouse monoclonal. All other reagents remain unchanged. This modification makes it possible to use an alternative, more rapid procedure with the same reagents: The 2rd Incubation (reaction with Enzyme-Anti-IgE) time can be shortened to 30 min (the "TEMPO procedure") or the standard incubation time of 150 min can be utilized (Standard Procedure). Other test parameters remain unchanged.

Here's an analysis of the provided text regarding the Pharmacia CAP System IgE FEIA device, structured according to your request:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: 106 patient samples.
• Data Provenance: Not specified, but the manufacturer is based in Sweden, so it's possible the samples are from Sweden or other European countries. The text indicates "human blood samples" in general. It is a retrospective comparison study to a predicate device.

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

• This information is not provided in the text. The study describes a comparison between two in vitro diagnostic devices, where the "ground truth" is essentially the measurements obtained from the predicate device.

4. Adjudication Method for the Test Set

• This information is not applicable as the study compares the performance of a modified device against a predicate device, rather than requiring expert adjudication of results. The results are quantitative measurements.

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

• No, an MRMC comparative effectiveness study was not done. This study is for an in vitro diagnostic device, not an imaging device requiring human reader interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Yes, the study assesses the standalone performance of the modified in vitro diagnostic device (Pharmacia CAP System IgE FEIA) by comparing its quantitative measurements to those of a predicate device. There is no human interpretation component described for the test results themselves.

7. Type of Ground Truth Used

• The ground truth used for comparison was the results obtained from the predicate device, Pharmacia CAP System IgE FEIA. This is a form of device-to-device comparison for substantial equivalence rather than comparison to a clinical outcome or pathological diagnosis.

8. Sample Size for the Training Set

• This information is not provided in the text, and it's unlikely a traditional "training set" as understood in machine learning was used, given the nature of this in vitro diagnostic device modification and study. The description details a modification to antibodies and a comparison study to demonstrate equivalence, not a machine learning model needing a training set.

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

• This information is not provided and is likely not applicable as the study design described does not involve a training set for a machine learning model.

Ask a specific question about this device