(98 days)
Midstream OneStep pregnancy test is Syntron Bioresearch, Inc. name for OTC use of solid phase immunoassay in vitro diagnostic test kit for the qualitative determination of human Chorionic Gonadotropin (hCG) in urine.
The Midstream and Besure Plus pregnancy test is a sandwich solid phase dye-conjugate non-enzyme immunoassay. As the specimen is added to the reaction device, the gold-solantibody conjugate binds to the hCG in the specimen forming an antibody-antigen complex. This complex binds to the anti-hCG antibody in the positive reaction zone and produces a purple-pink color band when hCG concentration is equal or greater than 25 mIU/ml. In the absence of hCG, there is no purple-pink line in the positive reaction zone. The reaction mixture continues to flow through the absorbent device, pass the positive reaction zone, producing a purple-pink color band, demonstrating that the reagents and device are functioning correctly.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance (Midstream OneStep) |
|---|---|
| Correlation with predicate device (Besure Plus OneStep hCG test) | 100% correlation |
| Correlation with clinical diagnosis | 100% correlation |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: 102 consumers (females) participated.
- 93 had a confirmed clinical diagnosis of non-pregnancy.
- 9 had a confirmed clinical diagnosis of pregnancy.
- Data Provenance: The data appears to be prospective, as consumers were specifically recruited to use both tests and compare results. The country of origin is not explicitly stated, but the company (Syntron Bioresearch, Inc.) is based in Carlsbad, CA, suggesting a US origin.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- The ground truth for the test set was established by physicians.
- The number of physicians is not explicitly stated.
- Their specific qualifications (e.g., years of experience, specialization) are not provided, only that they provided "clinical diagnosis."
4. Adjudication Method for the Test Set:
- The document implies a direct comparison, where consumers used both the Midstream OneStep test and the Besure Plus OneStep pregnancy test, and then their results were compared to the "clinical diagnosis submitted by physician."
- There's no explicit mention of an adjudication panel or a specific adjudication method like "2+1" or "3+1" for discrepancies between the device and the clinical diagnosis. The implication is that the clinical diagnosis served as the definitive ground truth.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No, an MRMC comparative effectiveness study was not done. This study focuses on the performance of a new device (Midstream OneStep) against a predicate device (Besure Plus OneStep) and clinical diagnosis, rather than comparing human reader performance with and without AI assistance. The device itself is a diagnostic test, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Yes, a standalone study was done. The "Midstream OneStep Pregnancy Home Test" results were obtained directly by consumers using the device. This represents the performance of the device without explicit human intervention or interpretation beyond the consumer reading the test result. The results were then compared to the predicate device and clinical diagnosis.
7. The Type of Ground Truth Used:
- The primary ground truth used was clinical diagnosis, as submitted by a physician.
- Additionally, the predicate device (Besure Plus OneStep immunoassay) also served as a comparative ground truth for the new device.
8. The Sample Size for the Training Set:
- This document describes a clinical performance study for a new device, not the development or training of an algorithm. Therefore, there is no mention of a training set or its sample size. The tests described are immunoassay kits, which do not typically involve machine learning training sets in their development and validation for this type of regulatory submission.
9. How the Ground Truth for the Training Set Was Established:
- As this is not an AI/algorithm study, the concept of a training set and its ground truth establishment is not applicable to this document.
§ 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.