(115 days)
The Guangzhou Wondfo Biotech Co., Ltd. One Step HCG Urine Pregnancy Test is intended for non-professional, over-the-counter use and for professional and laboratory use for the qualitative determination of elevated levels of human Chorionic Gonadotropin (hCG) in urine to aid in the determination of pregnancy.
The One Step HCG Urine Pregnancy Test is intended for use by professional healthcare personnel trained in its use and for Over-the-Counter use.
The device consists of a single test strip with one end designated for dipping, and control and test regions in the middle. At one end of the sample pad there is a line with arrows indicating which end of the strip should not be dipped below this line.
The One Step HCG Urine Pregnancy Test device is similar in design, materials and performance to other legally marketed "home pregnancy test devices" that are in commercial distribution.
Here's a breakdown of the acceptance criteria and study information for the One Step HCG Urine Pregnancy Test, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific acceptance criteria in terms of numerical performance targets (e.g., sensitivity, specificity, accuracy against a gold standard). Instead, the 510(k) summary focuses on demonstrating substantial equivalence to predicate devices. This means the device is considered acceptable if its performance is comparable to already legally marketed devices.
However, based on the nature of a pregnancy test, the implied acceptance criteria would revolve around the accurate detection of HCG. The "reported device performance" in this context refers to the successful demonstration of performance similar to predicate devices, which allowed for substantial equivalence.
| Performance Metric (Implied Acceptance Criteria) | Reported Device Performance (as implied by Substantial Equivalence) |
|---|---|
| Detection of hCG (Sensitivity & Specificity) | Comparable to predicate devices (Unipath, Ltd, E.P.T. Pregnancy Test, etc.) in detecting elevated levels of human Chorionic Gonadotropin (hCG) in urine. |
| Reliability and Consistency | Similar to predicate devices in design, materials, and method of manufacture, indicating comparable reliability. |
| Ease of Use (for OTC) | Designed for non-professional, over-the-counter use, similar to predicate OTC pregnancy tests. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not explicitly state the sample size used for any test set or the data provenance (e.g., country of origin, retrospective or prospective) for performance studies. The 510(k) summary primarily focuses on regulatory equivalence rather than detailed clinical study results in this document.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The provided text does not mention the number of experts used or their qualifications for establishing ground truth in any performance study. This type of detail is typically found in the full study report, which is not included here.
4. Adjudication Method
The provided text does not mention any adjudication method for a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not performed or reported in this document. The focus is on the device's standalone performance in comparison to predicate devices, not on human reader performance with or without AI assistance. The device is a "One Step HCG Urine Pregnancy Test," implying a direct read of a test line, not an AI-assisted diagnostic.
6. Standalone (Algorithm Only) Performance Study
As this is a chemical/biochemical diagnostic test (HCG urine test) and not an AI-driven device, the concept of a "standalone (algorithm only)" performance study does not apply. The device itself is the "standalone" entity that performs the detection. The 510(k) process for such devices relies on demonstrating the accuracy of the chemical reaction and visual interpretation.
7. Type of Ground Truth Used
The type of ground truth used to evaluate the performance of this device would typically involve a reference laboratory method for detecting HCG, such as a quantitative blood HCG test or another highly accurate and validated urine HCG test method. The provided text does not explicitly state the specific ground truth method used in any underlying studies, but it is implied to be related to the "quantification" or "detection" of hCG.
8. Sample Size for the Training Set
The provided text does not mention any training set sample size. As this is a chemical diagnostic test that works based on a fixed biochemical reaction, there is no "training set" in the machine learning sense. The device's design and materials are optimized through development, not by training an algorithm on a data set.
9. How the Ground Truth for the Training Set Was Established
Since there is no "training set" in the context of an algorithm for this device, the question of how its ground truth was established does not apply. The performance of the test relies on the inherent chemical properties and design, which are validated against known HCG concentrations and clinical samples in studies.
§ 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.