(30 days)
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.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device (ICON® II HCG) | Overall level of agreement with ICON® II HCG was greater than 99.5% for both urine and serum samples. |
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.
§ 862.1155 Human chorionic gonadotropin (HCG) test system.
(a)
Human chorionic gonadotropin (HCG) test system intended for the early detection of pregnancy —(1)Identification. A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class II.(b)
Human chorionic gonadotropin (HCG) test system intended for any uses other than early detection of pregnancy —(1)Identification. A human chorionic goadotropin (HCG) test system is a device intended for any uses other than early detection of pregnancy (such as an aid in the diagnosis, prognosis, and management of treatment of persons with certain tumors or carcinomas) is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class III.(3)
Date PMA or notice of completion of a PDP is required. As of the enactment date of the amendments, May 28, 1976, an approval under section 515 of the act is required before the device described in paragraph (b)(1) may be commercially distributed. See § 862.3.