(73 days)
MidStream™ Home Pregnancy Test is intended for nonprofessional 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 urinating on the absorbent wick and observing for the formation of colored bands. 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 band on the Specimen portion of the membrane. Absence of this colored band suggests a negative result. To serve as a procedural control, a colored band at the Control Zone will always appear regardless of the presence or absence of hCG.
Here's a summary of the acceptance criteria and study details for the MidStream™ Home Pregnancy Test based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Detection of hCG at 25 mIU/ml and greater | Detects hCG concentrations of 25 mIU/ml and greater |
| No cross-reactivity with hLH, hFSH, hTSH | No cross-reactivity shown with hLH (500 mIU/ml), hFSH (1000 mIU/ml), and hTSH (1000 µIU/ml) |
| Overall agreement with laboratory results | Overall agreement of 99.1% |
| Ease of use by non-professional users | Majority of participants found the test very easy to use, had no trouble understanding labeling, instructions, or interpreting results |
| Suitable for over-the-counter pregnancy testing | Confirmed as suitable based on clinical trial results |
2. Sample Size for the Test Set and Data Provenance
- Sample Size: 112 female participants.
- Data Provenance: Not explicitly stated, but implied to be from a clinical trial in the context of a US regulatory submission (FDA). The data is prospective as it involves actively testing participants and gathering their results, comparing them to laboratory results.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not explicitly state the number of "experts" used for establishing ground truth for the test set beyond the mention of "laboratory results." However, it implies that professional laboratory testing served as the reference standard. The qualifications of the personnel performing these laboratory tests are not detailed.
4. Adjudication Method for the Test Set
The document does not describe an explicit adjudication method (like 2+1 or 3+1). It states a "comparison study between the participants results and laboratory results," suggesting a direct comparison without complex adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study compares the self-interpretation of the home test by participants to laboratory results, not the performance of human readers with vs. without AI assistance. This device is a standalone diagnostic kit, not an AI-assisted diagnostic tool.
6. Standalone Performance
Yes, a standalone performance study was done. The entire clinical trial evaluates the device's performance (i.e., the algorithm/test strip's ability to detect hCG) when used by the intended non-professional users. The comparison is between the users' interpretations of the device's results and professional laboratory results.
7. Type of Ground Truth Used
The ground truth used was laboratory results, which would typically involve high-sensitivity quantitative or qualitative hCG assays performed by trained laboratory personnel.
8. Sample Size for the Training Set
The document does not specify a separate "training set" or its sample size. This is a traditional in-vitro diagnostic device, not a machine learning model, so the concept of a "training set" in the AI sense does not apply. The inherent design and components of the test (antibodies, membrane chemistry) are developed and refined through R&D, not through an iterative machine learning training process with a distinct training dataset.
9. How Ground Truth for the Training Set Was Established
As noted above, the concept of a "training set" in the context of an AI/ML model is not applicable here. The "ground truth" for the development of the test strip itself would be based on established biochemical principles of antigen-antibody detection, using known concentrations of hCG and other structurally similar hormones to ensure specificity and sensitivity during product development and manufacturing quality control.
§ 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.