(62 days)
AimStep™ Pregnancy is intended for non-professional use for the qualitative identification of hCG (human Chorionic Gonadotropin) in urine to aid in the determination of pregnancy.
The test utilizes a combination of monochonal and polyclonal antibody reagents to selectively devect elevated levels of hCG. The assay is conducted by adding urine to the test device and observing for the formation of colored lines. The specimen migrates via capillary action along the membranc to react with the colored conjugate. Positive specimens react with the specific antibody-hCG-colored conjugate and form a colored line on the "Test Region" of the membrane. Absence of this colored line suggests a negative result. To serve as a procedural control, a colored line at the Control Region will always appear regardless of the presence or absence of hCG.
This document describes the acceptance criteria and study proving the performance of the AimStep™ Pregnancy (Home Test).
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Detection of hCG at 20 mIU/ml and greater | The AimStep™ Pregnancy test detects hCG concentrations of 20 mIU/ml and greater. |
| No cross-reactivity with hLH (300 mIU/ml), hFSH (1000 mIU/ml), and hTSH (1000 µIU/ml) | The addition of hLH (300 mIU/ml), hFSH (1000 mIU/ml), and hTSH (1000 µIU/ml) to negative (0 mIU/ml hCG) and positive (20 mIU/ml hCG) urine showed no cross-reactivity. |
| Accuracy (Correlation with predicate device) | Over 99% correlation between AimStep™ Pregnancy and the Clearview™ Easy HCG Pregnancy Test. |
| Ease of use and clear instructions for non-professional users | The majority of participants found AimStep™ Pregnancy very easy to use, and had no trouble understanding the labeling, reading the instructions, or interpreting the results. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 137 female participants.
- Data Provenance: The document does not explicitly state the country of origin. It is a "clinical trial," which implies prospective data collection, but this is not explicitly confirmed. Given the context of a 510(k) submission to the FDA, it is highly likely the study was conducted in the USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not mention the use of experts to establish ground truth for the test set. The comparison was made against a predicate device (Clearview™ Easy HCG Pregnancy Test), which itself is a legally marketed device for pregnancy determination. The results of the predicate device served as the reference for comparison.
4. Adjudication Method for the Test Set
Not applicable. The study compared the device's results directly to a predicate device, not against an adjudicated ground truth from multiple experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study focused on the performance of the device against a predicate device, not on the improvement of human readers with or without AI assistance.
6. Standalone Performance Study
Yes, a standalone performance study was conducted in the sense that the AimStep™ Pregnancy device was evaluated on its own ability to detect hCG and its correlation with a predicate device. The accuracy of detecting hCG at 20 mIU/ml and greater, and the lack of cross-reactivity, represent standalone performance metrics.
7. Type of Ground Truth Used
The ground truth for the clinical trial was established by the results of the legally marketed predicate device, the Clearview™ Easy HCG Pregnancy Test. This implies a "device-to-device comparison" ground truth where the established accuracy of the predicate device is assumed to be the truth for the purpose of comparison. The primary function of the test is for "identification of hCG," and its ability to detect specific concentrations and show no cross-reactivity suggests a chemical/biological assay's intrinsic truth as well.
8. Sample Size for the Training Set
The document does not explicitly mention a training set or its sample size. The description of the device's performance (e.g., detection limit, cross-reactivity) suggests laboratory testing and standardization, which would involve samples, but these are not referred to as a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as a "training set" in the context of machine learning is not described. The device's performance characteristics (detection limit, cross-reactivity) would have been established through laboratory experiments and standardization to the World Health Organization Third International Standard, which serves as a definitive reference for hCG measurement.
§ 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.