(98 days)
ACON™ One Step Home Pregnancy Test Strip is intended for nonprofessional use for the qualitative identification of human chorionic gonadotropin (hCG) in urine to aid in the determination of pregnancy.
ACON™ One Step Home Pregnancy Test Strip is intended for non-professional use for the identification of hCG (human chorionic gonadotropin) in urine to aid in the determination of pregnancy. The test utilizes a combination of monoclonal and polyclonal antibody reagents to selectively detect elevated levels of hCG. The assay is conducted by dipping the absorbent wick of the test in urine and observing for the formation of colored lines. The specimen migrates via capillary action along the wick and membrane to react with the colored conjugate. Positive specimens react with the specific antibody-hCG-colored conjugate and form a colored line on the Test portion of the membrane. Absence of this colored line suggests a negative result. To serve as a procedural control, a colored line at the Control zone will always appear regardless of the presence or absence of hCG.
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1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Analytical Sensitivity: Detect hCG concentrations of 25 mIU/ml and greater. | Detects hCG concentrations of 25 mIU/ml and greater. (Confirmed) |
| Specificity/Cross-Reactivity: No cross-reactivity with hLH, hFSH, and hTSH at specified concentrations. | No cross-reactivity with hLH (300 mIU/ml), hFSH (1000 mIU/ml), and hTSH (1000μIU/ml) when added to negative and positive urine. (Confirmed) |
| User Comprehension & Ease of Use (for OTC use): Participants found it easy to use, understood labeling, instructions, and interpreted results correctly. | Majority of 73 female participants found it "very easy to use," "had no trouble understanding the labeling," "reading the instructions," or "interpreting the results." (Confirmed) |
| Suitability for Over-the-Counter Pregnancy Testing: Overall performance confirms suitability. | "The overall results of the clinical trial confirm that ACON™ One Step Home Pregnancy Test Strip is a suitable test for over-the-counter pregnancy testing." (Confirmed) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 73 female participants.
- Data Provenance: The document doesn't explicitly state the country of origin. Given the manufacturer's address (San Diego, CA, USA) and submission to the FDA, it's highly likely the study was conducted in the United States. The study appears to be prospective as it involved clinical trials with participants.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not explicitly state the number of experts or their qualifications for establishing the ground truth of the pregnancy status in the 73 participants. Given it's a home pregnancy test, the "ground truth" would generally be established by confirming pregnancy status through other clinical methods (e.g., blood tests, physician diagnosis) or the participants' self-reported pregnancy status linked to other medical confirmation.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the interpretation of test results or the establishment of ground truth. For home pregnancy tests, the user themselves is the primary interpreter, and the study focuses on their ability to interpret correctly.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This type of study is more common for diagnostic imaging AI where multiple expert readers interpret cases with and without AI assistance to measure human performance improvement. For a home-use diagnostic device like this, the focus is on the general population's ability to use and interpret the test effectively as a standalone device.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, a standalone performance evaluation of the device (i.e. the test strip itself, without considering user interpretation accuracy as part of the core performance) was done to establish its analytical performance. The document describes:
- Analytical Sensitivity: "The ACON™ One Step Home Pregnancy Test Strip detects hCG concentrations of 25 mIU/ml and greater." This is a direct measure of the device's inherent capability to detect hCG.
- Specificity/Cross-Reactivity: "The addition of hLH (300 mIU/ml), hFSH (1000 mIU/ml), and hTSH (1000μIU/ml) to negative (0 mIU/ml hCG) and positive (25 mIU/ml hCG) urine showed no cross-reactivity." This demonstrates the device's ability to accurately identify hCG without interference from other hormones.
These tests were performed in a controlled laboratory setting to ascertain the device's technical specifications.
7. The Type of Ground Truth Used
- Analytical Ground Truth (for sensitivity and specificity): The ground truth was established by using known concentrations of hCG and interfering substances (hLH, hFSH, hTSH) in urine samples. This is a form of controlled laboratory standard.
- Clinical Ground Truth (for user comprehension/interpretation): While not explicitly detailed, the ultimate ground truth for the clinical trial would be the actual pregnancy status of the 73 female participants, likely corroborated by other clinical methods (e.g., blood tests by a healthcare provider). The study focuses, however, on the users' ability to interpret the device's output correctly against their known status, rather than the device's absolute accuracy in a vacuum.
8. The Sample Size for the Training Set
The document does not mention a specific training set. This is because the ACON™ One Step Home Pregnancy Test Strip is a chemical-based in-vitro diagnostic device, not an AI/machine learning algorithm that requires a training dataset. The development and calibration of such a device are based on biochemical principles and laboratory testing, not iterative machine learning.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set for an AI/machine learning algorithm, this question is not applicable. The standardization of the test's analytical performance was against the "World Health Organization Third International Standard" for hCG, which serves as a global reference.
§ 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.