(120 days)
The FIRST RESPONSE® GOLD™ Digital Pregnancy Test is an in vitro diagnostic test device intended for use by the lay user for the early detection of pregnancy prior to the expected menses. The test is indicated for use from four days before the expected period, that is, five days before the missed period.
The First Response Gold Digital Pregnancy Test is an in vitro diagnostic test device intended for the early detection of pregnancy by the lay user up to five (5) days sooner than the day of the missed period (four (4) days before the day of the expected period). The test detects human chorionic gonadotropin in urine.
The FIRST RESPONSE® GOLD™ Digital Pregnancy Test is a human chorionic gonadotropin (hCG) test system. It is a device intended for use by the lay user in the early detection of pregnancy by the detection of hCG, a placental hormone in urine. The device detects the presence of hCG in the urine of a pregnant woman by way of a series of immunochemical reactions on a chromatographic strip contained within a plastic housing, which is integral with the digital component that reads and displays the result of the immunochemical reactions on the Display Screen of the device in a manner similar to the predicate device.
The subject 510(k) device and its analog counterpart First Response Early Result Pregnancy Test (K#030258) utilize the identical immunochemical principles for the assay of hCG: an immunochromatographic assay using colloidal gold as a direct label. The subject 510(k) device differs in that it provides a digital display of the test result for the consumer to read in place of the colored lines of the above referenced analog device. The digital version of the device incorporates into the stick housing electronic and optical components along with a microprocessor and specific algorithms capable of determining and correctly interpreting the reaction result and displaying a simple "YES+" or "-NO" on a Display Screen. The digital device is battery powered and will display the result for at least thirty minutes after completion of the reaction. All components are integrated and unitized into the stick housing.
1. Table of Acceptance Criteria and Reported Device Performance:
The provided text only includes the intended use and a description of the device's technical characteristics, but not specific acceptance criteria or performance metrics such as sensitivity and specificity. Therefore, I cannot generate a table demonstrating acceptance criteria and device performance. The information states that the device detects hCG and displays a digital result "YES+" or "-NO".
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the sample size used for any test set or the provenance of the data (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
The document does not provide information on the number or qualifications of experts used to establish ground truth for any test set.
4. Adjudication Method for the Test Set:
The document does not describe any adjudication method used for a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The document does not mention an MRMC comparative effectiveness study or any effect size related to human readers improving with AI assistance. The device is for lay user home testing, not clinical interpretation.
6. Standalone Performance (Algorithm Only):
The device itself is a standalone system for a lay user. However, the document does not present specific "standalone" performance metrics in terms of sensitivity, specificity, or accuracy that would typically be associated with an algorithm-only evaluation against a formal ground truth. It describes the device's ability to interpret reactions and display a digital result, implying an internal algorithm.
7. Type of Ground Truth Used:
The document does not explicitly state the type of ground truth used for any evaluation. However, given its function as a pregnancy test, the inherent ground truth would be the actual pregnancy status of the individual. This would typically be confirmed by clinical methods or subsequent outcomes.
8. Sample Size for the Training Set:
The document does not provide any information regarding the sample size used for a training set.
9. How Ground Truth for the Training Set Was Established:
The document does not describe how ground truth was established for any training set.
§ 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.