Search Results

The ICON® Fx hCG test is a rapid qualitative test designed to detect human chorionic gonadotropin (hCG) in urine or serum, as an aid in the early detection of pregnancy. The ICON® Fx hCG test is for professional use.

The ICON® Fx hCG test uses two distinct monoclonal antibodies specific to the alpha and beta subunits of hCG to provide a test capable of detecting hCG concentrations as low as 20 mIU/mL urine and 10 mIU/mL serum (IU=International Units).

Here's an analysis of the acceptance criteria and study information for the ICON® Fx hCG Immunochemical Test based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical targets in the provided text. Instead, the study's goal appears to be demonstrating "substantial equivalence" to the predicate device, ICON® II HCG. The primary performance metric reported is "overall level of agreement" with the predicate device.

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

• Sample Size for Test Set: Not explicitly stated as a number of samples. The text mentions "multi-center clinical trial testing" (Section 4).
• Data Provenance: Not explicitly stated (e.g., country of origin). The text indicates it was from "multi-center clinical trial testing," suggesting prospective data collection.

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

Not applicable. This device is an in-vitro diagnostic test. "Ground truth" for such devices is established by comparing its results to a reference method or a legally marketed predicate device, as seen in the comparison to ICON® II HCG. There is no mention of human expert interpretation being the ground truth.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the ground truth is against a predicate device, not human expert interpretation that would require adjudication.

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

No, an MRMC comparative effectiveness study was not done. The study focused on the agreement between the new device (ICON® Fx hCG) and a predicate device (ICON® II HCG), not on comparing human reader performance with and without AI assistance.

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

Yes, a standalone study was performed. The ICON® Fx hCG is a qualitative immunochemical test designed for visual detection without instrumentation required. Its performance (detection of hCG) is evaluated independent of a human-in-the-loop scenario beyond the visual interpretation of the test result itself. The agreement greater than 99.5% is the standalone performance of the Fx hCG compared to the predicate.

7. The Type of Ground Truth Used

The ground truth was established by comparison to a legally marketed predicate device, the ICON® II HCG ImmunoConcentration™ Assay.

8. The Sample Size for the Training Set

Not applicable. This is an immunoassay, not an AI/machine learning algorithm that requires a training set in the conventional sense. The "training" would be more akin to assay development and optimization, rather than machine learning training data.

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

Not applicable, as there is no training set in the AI/machine learning context for this device. The development of the assay itself would involve optimizing its components to achieve desired sensitivity and specificity, likely against known hCG concentrations and reference materials.

Ask a specific question about this device