(172 days)
The First Response® 1-Step Pregnancy Test is an at-home pregnancy test marketed over-the-counter (OTC) to lay consumers. The First Response® I-Step Pregnancy Test detects the presence of hCG in the urine as an aid in the carly diagnosis of pregnancy. The test, which can be used anytime of the day, can detect hCG as early as three days before the expected period.
The First Response®1-Step Pregnancy Test is a Class II in vitro diagnostic medical device product that functions by way of a double antibody immunochromatographic assay in detecting the presence of hCG in the urine as an aid in the early diagnosis of pregnancy. It consists of a plastic stick, which contains an absorbent tip that protrudes from the end of the device and collects and delivers urine to reagents on a chromatographic strip contained within the device. The test is performed by placing the absorbent tip of the device in the urine stream for 5 seconds or by immersing the absorbent tip into a container of urine for 5 seconds. The absorbent section of the strip allows the urine sample to move chromatographically along the reagent strip reconstituting the diffusible reagents placed strategically along the strip and delivering them to the appropriate capture zones for visualization of the test results. The detection of hCG (pregnant) in the urine sample is indicated by the appearance of two pink lines in the test window. If there is no hCG (not-pregnant) in the urine, one pink line will appear.
The acceptance criteria for the First Response® 1-Step Pregnancy Test and the studies proving it meets these criteria are described below:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Consumer accuracy in reading low levels of hCG | Evaluated in a performance study |
| Ability of lay consumers to perform the test and interpret the result | Evaluated in a performance study |
| Ability to understand the package insert, including use before the expected period | Evaluated in a quantitative market research study |
| Clinical sensitivity using samples collected prior to missed menses | Evaluated and confirmed in a laboratory study |
2. Sample Size and Data Provenance
- Test Set Sample Size: Not explicitly stated in the provided text for individual studies.
- Data Provenance: Not explicitly stated, but the studies were conducted by Carter-Wallace, Inc., in the United States.
3. Number of Experts and Qualifications for Ground Truth
- Not applicable as the ground truth was established through laboratory testing for clinical sensitivity and consumer studies for user performance and comprehension, rather than expert consensus on diagnostic images or conditions.
4. Adjudication Method
- Not applicable for the types of studies described. Clinical sensitivity would rely on laboratory reference methods, and consumer studies would involve direct observation and survey results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned. The studies focused on the device's standalone performance and consumer interaction rather than comparing human readers with and without AI assistance.
6. Standalone (Algorithm Only) Performance Study
- Yes, standalone performance studies were done. The text describes a laboratory study to evaluate and confirm the clinical sensitivity of the First Response® 1-Step Pregnancy Test using samples collected prior to missed menses. This assesses the device's ability to detect hCG independently. Additionally, consumer accuracy in reading low levels of hCG suggests a standalone assessment of the device's output interpretation by users.
7. Type of Ground Truth Used
- Clinical Sensitivity: Likely laboratory reference methods for hCG detection (e.g., quantitative serum hCG assays) or established clinical diagnosis of pregnancy.
- Consumer Accuracy/Performance/Comprehension: Actual presence or absence of hCG in urine samples (for accuracy) and direct observation or survey responses regarding user actions and understanding.
8. Sample Size for the Training Set
- Not applicable. This device is an in-vitro diagnostic test, not an AI or machine learning algorithm that requires a training set.
9. How Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for this type of device.
§ 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.