(175 days)
The FIRST RESPONSE® Early Result Pregnancy Test is an in vitro diagnostic home use test device intended for the early detection of pregnancy. The test may detect the pregnancy hormone (hCG), in some cases, as early as 6 days before the missed period (5 days before the expected period). This test is only intended for individual use at home. It is not intended for use in a healthcare setting.
The FIRST RESPONSE® Early Result Pregnancy Test is a human chorionic gonadotropin (hCG) test system. It is a screening device intended for early detection of pregnancy by the lay user for the qualitative measurement of hCG in urine as early as six (6) days before the day of the missed period. The device detects the presence of hCG in the urine of a pregnant woman by way of a series of immunochemical reactions via component reagents that are striped onto a chromatographic strip contained within a plastic housing. Following the instructions for use provided with the device, the test is performed by placing the absorbent collection tip into the urine stream (alternatively a cup of urine may be used) for 5 seconds. The test result is read in the housing window after the elapse of 3 minutes. Two pink lines indicate hCG has been detected (pregnant); one pink line indicates no hCG has been detected (not pregnant).
The provided document describes the FIRST RESPONSE® Early Result Pregnancy Test, an at-home pregnancy test that detects human chorionic gonadotropin (hCG) in urine. The key focus of the submission is a modification to the device to achieve increased analytical and clinical sensitivity, allowing for earlier detection of pregnancy (6 days before the missed period, compared to 5 days for the predicate device).
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state quantitative acceptance criteria in a table format. However, the primary acceptance criterion inferred from the submission is the ability of the device to detect hCG as early as 6 days before the missed period both analytically and when interpreted by consumers. The reported device performance is that it achieves this increased sensitivity and consumers can accurately read and interpret the results at this earlier time point.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Analytical Sensitivity: Increased detection capability to identify hCG at levels present 6 days before the missed period. | The device uses a different size gold particle and modified streptavidin to achieve an increased analytical sensitivity, allowing detection of hCG earlier in pregnancy (6 days before the missed period). |
| Clinical Sensitivity/Usability: Consumers can accurately read and interpret results from early pregnancy urines 6 days before the missed period. | A consumer study confirmed professional testing and verified the device performance characteristics with early pregnancy urines, demonstrating that the results of the test can be accurately read and interpreted by consumers as early as 6 days before the missed period. The labeling claim and directions for use were modified accordingly. |
| Substantial Equivalence: Maintain substantial equivalence to the predicate device despite modifications. | The FDA determined the device is substantially equivalent to legally marketed predicate devices, subject to general controls. |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions a "consumer study" and "professional testing" to verify device performance. However, it does not specify the sample size used for the test set. The data provenance is also not explicitly stated in terms of country of origin or whether it was retrospective or prospective. It is implied to be prospective data collection, as it's a study designed to verify the performance of the modified device with "early pregnancy urines."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document states, "A consumer study confirmed professional testing and verified the device performance characteristics..." This implies that "professional testing" established a ground truth against which consumer results were compared. However, the number of experts and their specific qualifications (e.g., medical professionals, lab technicians, etc.) are not provided.
4. Adjudication Method for the Test Set
The document mentions "professional testing" and a "consumer study," indicating a comparison. However, the specific adjudication method (e.g., 2+1, 3+1, none) for the test set is not described. It can be inferred that the professional testing results served as a reference or a form of adjudicated truth for the consumer study, but the methodology of this adjucation is absent.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No MRMC comparative effectiveness study is mentioned. The study described focuses on consumer interpretation of the device's results, not a comparison of human readers' performance with and without AI assistance. The device itself is an in-vitro diagnostic test, not an AI-powered diagnostic tool requiring human-in-the-loop analysis.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
The device is an at-home pregnancy test, meaning the "algorithm" (the immunochemical reactions on the strip) performs standalone, and the consumer then interprets the visual result (one or two lines). The "consumer study" specifically evaluates the human interpretation aspect. Therefore, a standalone performance of the immunochemical test (the core of the "algorithm") is implicitly what "professional testing" would assess, and the consumer study then assesses the human interpretation of that standalone output. The document does not explicitly present data from an "algorithm only" study in isolation from any human interpretation, but the entire device functions in a standalone manner before human interpretation.
7. The Type of Ground Truth Used
The ground truth for the "consumer study" was established through "professional testing" using "early pregnancy urines." This implies that the presence and concentration of hCG in these urine samples were independently verified and quantified by professional laboratory methods, serving as the objective ground truth for pregnancy status.
8. The Sample Size for the Training Set
The document does not mention a separate "training set" or its sample size. The description indicates a modification to an existing device (predicate device) and subsequent verification studies (professional testing and a consumer study) for the modified device. There is no indication of a machine learning model being trained, which would typically require a training set.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned in the context of a machine learning model, this information is not applicable and not provided. The studies described are for verification of the modified device's performance.
§ 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.