(190 days)
UCP Pregnancy Cassette Test 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 device is intended for Prescription Use Only including at point of care sites.
UCP Pregnancy Dip Card/Strip 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 device is intended for Prescription Use Only including at point of care sites.
UCP Home Pregnancy Cassette Test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy.
UCP Home Pregnancy Midstream Test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy.
UCP Home Pregnancy Dip Card/Strip is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy.
U
Here's an analysis of the provided text, focusing on the acceptance criteria and the study proving the device meets them:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance:
| Parameter | Acceptance Criteria (from Predicate Device) | Reported Device Performance (UCP Home/Pregnancy Test) |
|---|---|---|
| Sensitivity | 25 mIU/mL | 25 mIU/mL |
| Specificity | No interferences when tested with LH, FSH and TSH | No interferences when tested with LH, FSH and TSH |
| Agreement (Professional vs. Professional) | Not explicitly stated, but predicate performance is the benchmark. | 100% agreement with predicate device results |
| Agreement (Lay User vs. Professional) | Not explicitly stated, but high agreement is implied for OTC use. | 100% agreement between lay users and professionals for UCP Home Pregnancy Tests |
| Ease of Use/Interpretation (Lay User) | Not explicitly stated, but essential for OTC. | Participant responses support easy understanding of instructions and interpretation of results. |
Study Proving Device Meets Acceptance Criteria:
The document describes several studies to demonstrate the safety and effectiveness of the UCP Home Pregnancy Tests/UCP Pregnancy Tests, thereby showing it meets the acceptance criteria (primarily by demonstrating substantial equivalence to the predicate device).
2. Sample Size and Data Provenance:
- Test Set Sample Size: 100 urine specimens.
- Data Provenance: The document does not explicitly state the country of origin. It indicates that the specimens were collected from "100 women who fit into the following categories: childbearing age, suspected pregnant women, women early in pregnancy, and the first trimester of pregnancy." The study appears to be prospective in the sense that the collection of specimens and testing were part of this specific comparison study.
3. Number and Qualifications of Experts for Ground Truth:
- Number of Experts: Not explicitly stated, but "lab professionals" are mentioned as performing testing for both the candidate and predicate devices. It is implied that these professionals are the "experts" in this context.
- Qualifications of Experts: "Lab professionals" are mentioned. No further specific qualifications (e.g., years of experience, specific certifications) are provided.
4. Adjudication Method for the Test Set:
- The document implies a direct comparison, stating "There was 100% agreement between UCP Home Pregnancy Test results by lay users and by the professionals. The results were also 100% in agreement between UCP Home Pregnancy Tests/UCP Pregnancy Tests and the predicate device results tested by the professionals." This suggests a direct comparison method rather than a formal adjudication process (like 2+1 or 3+1). The predicate device's results, as interpreted by lab professionals, served as the primary benchmark.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done in the sense of evaluating how much human readers improve with AI assistance. This device is a rapid chromatographic immunoassay (a "stick test") for qualitative detection of hCG, not an AI-powered diagnostic imaging or analysis system that would typically be evaluated with MRMC studies.
- However, there was a comparison of "readers" – specifically, lay users versus lab professionals – to assess the ease of use and interpretation for the Over-The-Counter (OTC) versions of the device. This is a different type of "reader" evaluation.
6. Standalone (Algorithm Only) Performance Study:
- The concept of a "standalone (algorithm only)" study is not applicable here because the device is a physical, chemical immunoassay, not an algorithm. The device itself is the "standalone" component in its intended use. The performance characteristics (sensitivity, specificity, precision, etc.) were established for the device itself.
7. Type of Ground Truth Used:
- The primary ground truth appears to be expert consensus / established clinical practice as demonstrated by the predicate device's results when interpreted by "lab professionals."
- Implicitly, the presence of hCG in the urine specimens (from "suspected pregnant women, women early in pregnancy, and the first trimester of pregnancy") serves as the underlying clinical truth.
8. Sample Size for the Training Set:
- The concepts of "training set" and "test set" are typically used for machine learning algorithms. For this type of immunoassay, there isn't a "training set" in the machine learning sense. The "training" or development of the device would involve biochemical formulation and optimization, not data-driven algorithm training.
- The document describes "comparison studies" using 100 urine specimens as the "test set" for performance evaluation against the predicate.
9. How Ground Truth for the Training Set Was Established:
- As there is no "training set" in the AI/ML context for this device, this question is not applicable. The development and calibration of the assay would rely on established biochemical principles and standards (e.g., WHO Fourth International Standard for hCG).
§ 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.