(81 days)
The AZOG hCG One-Step (Urine) Pregnancy Test (Device or Cassette) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy.
AZOG, INC. hCG One-Step Urime Pregnancy test is intended for the qualitative determination of Human Chorionic Gonadotropin (hCG) in Human Urine The test is for professional use only.
The AZOG hCG One-Step Pregnancy Test (Urine) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. The test utilizes a combination of antibodies including a monoclonal hCG antibody to selectively detect elevated levels of hCG. The assay is conducted by adding urine into the sample well of the device and observing the formation of colored lines. The specimen migrates via capillary action along the membrane to react with the colored conjugate. Positive specimens react with the specific antibody-hCG-colored conjugate to form a colored line at the test line region of the membrane. Absence of this colored line suggests a negative result. To serve as a procedural control, a colored line will always appear at the control line region if the test has been performed properly.
Here's a breakdown of the acceptance criteria and the study that demonstrates the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Sensitivity (Detection limit of hCG) | Detects hCG at 25 mIU/mL or greater. |
| Specificity (No cross-reactivity with other hormones) | No cross-reactivity observed with LH (1000 mIU/mL), FSH (1000 mlU/mL), and TSH (1000 ulU/mL) at both negative (0 mlU/mL hCG) and positive (25 mIU/mL hCG) levels. |
| Overall Agreement/Accuracy (Compared to a similar device) | 100% overall agreement with a similar device. |
| Assay Precision/Tolerance (Reproducibility within and between runs/operators) | No differences observed within run (5 replicates), between runs (three different assay days), or between operators (two operators) for negative, low positive, and high positive specimens. |
| Interference (No interference from potentially interfering substances) | None of the potentially interfering substances tested interfered with the assay. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 150 urine specimens were used for the correlation study. For the precision/tolerance study, a panel of 3 coded specimens (negative, low positive, and high positive) were tested.
- Data Provenance: The document does not specify the country of origin of the data. The studies appear to be prospective, as they involve testing the device with specific specimens to evaluate its performance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not explicitly state the number of experts used or their qualifications for establishing ground truth. For the correlation study, the "ground truth" was established by comparing the results of the AZOG device to a "similar device," implying that the similar device's results were considered the reference.
4. Adjudication Method for the Test Set
The document does not detail an adjudication method. For the correlation study, it was a direct comparison of results to a "similar device." For precision, it was an assessment of consistency across runs and operators.
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 done. The study focuses on the standalone performance of the device and its agreement with a predicate device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance study was done. The document describes the device's ability to detect hCG, its sensitivity, specificity, precision, and freedom from interference, all of which are characteristics of the device's inherent performance. The "Correlation" study compared the device's results to another device, essentially evaluating its standalone accuracy.
7. The Type of Ground Truth Used
- For the correlation study, the ground truth was established by the results obtained from a similar, presumably already validated, device.
- For sensitivity, the ground truth was based on known concentrations of hCG (25 mIU/mL or greater).
- For specificity, the ground truth was based on known concentrations of other hormones (LH, FSH, TSH) in both negative and positive hCG specimens.
- For precision/tolerance, the ground truth involved coded specimens with known (negative, low positive, high positive) hCG status to assess consistency.
8. The Sample Size for the Training Set
The document does not mention a "training set" in the context of device development or machine learning. For traditional immunoassay devices, there isn't a separate training set in the same way there would be for an AI/ML algorithm. The development of the device's reagents and design would implicitly use various samples during the R&D phase, but these are not typically referred to as a "training set" in regulatory submissions for these types of devices.
9. How the Ground Truth for the Training Set Was Established
As no "training set" is explicitly mentioned for this type of immunoassay device, the method for establishing its ground truth is not applicable. The device's performance relies on the biochemical specificity of its antibodies and the design of the assay, rather than learned patterns from a training dataset.
§ 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.