(52 days)
The Brand Name 1-Step Pregnancy Test is an at-home pregnancy test marketed over-the-counter (OTC) to lay consumers. The Brand Name 1-Step Pregnancy Test detects the presence of hCG in the urine as an aid in the early diagnosis of pregnancy. The test, which can be used anytime of the day, can detect hCG as early as the first day of the missed menses.
The Brand Name 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.
Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and supporting studies for the "Brand Name 1-Step Pregnancy Test":
1. Acceptance Criteria and Reported Device Performance
The provided document details various performance studies but does not explicitly state numerical acceptance criteria for sensitivity, specificity, or agreement. Instead, it describes general objectives and outcomes. However, it implicitly demonstrates that the device met the criteria for substantial equivalence to the predicate device.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Laboratory Accuracy | Two laboratory studies compared the Brand Name 1-Step Pregnancy Test to the predicate device, First Response® 1-Step Pregnancy Test, to determine its performance. |
| Sensitivity | A third laboratory study was performed to evaluate and confirm the sensitivity of the Brand Name 1-Step Pregnancy Test. |
| Lay Consumer Performance | Three separate studies evaluated the ability of consumers to perform and interpret the Brand Name 1-Step Pregnancy Test using both midstream and dip methods. |
| Substantial Equivalence | The FDA determined the device is substantially equivalent to legally marketed predicate devices, implying that its performance aligns with existing standards for such devices. |
| Intended Use Fulfillment | The device successfully detects hCG in urine as an aid in the early diagnosis of pregnancy and can be used by lay consumers anytime of the day, as early as the first day of missed menses. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes for the test sets in any of the described studies (laboratory accuracy, sensitivity, or consumer use).
Regarding data provenance, the studies are described as "laboratory studies" and "studies" evaluating consumer ability. Given the context of a 510(k) submission for a new product, these would almost certainly be prospective studies conducted specifically for this submission. The document does not mention the country of origin of the data, but
given the submitter is Carter-Wallace in Cranbury, New Jersey, it is highly probable the
studies were conducted in the United States.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not specify the number of experts used or their qualifications for establishing ground truth in the laboratory studies. For a hCG test, the ground truth for positive/negative results would typically be established by:
- Quantitative laboratory assays: Using a highly accurate reference method to measure hCG levels.
- Clinical assessment: In some cases, confirming pregnancy status through other clinical means (though less common for in vitro diagnostic ground truth).
For the consumer studies, the "ground truth" for the interpretation ability would be derived from comparison to the device's actual performance (i.e., whether the consumer's interpretation matched the correct result as determined by the laboratory).
4. Adjudication Method for the Test Set
The document does not describe any adjudication method (e.g., 2+1, 3+1, none) for the test sets. For IVD devices like pregnancy tests, adjudication among human readers or experts is less common for establishing the analytical ground truth (presence or absence of hCG) as the results are typically objectively measured by quantitative methods. However, for the consumer interpretation studies, it's possible internal protocols were used to resolve discrepancies if consumers disagreed on the interpretation of a test result, but this is not detailed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The document describes laboratory studies comparing the new device to a predicate device, and consumer studies to assess user interpretation. These are not MRMC studies designed to assess the improvement of human readers with AI assistance, as this is a standalone 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 form of standalone performance was assessed. The "Brand Name 1-Step Pregnancy Test" is an in vitro diagnostic device, not an algorithm. Its "standalone" performance refers to its ability to detect hCG accurately on its own. The laboratory studies ("evaluation of the laboratory accuracy" and "evaluate and confirm the sensitivity") directly assess this standalone performance – how well the device itself, without human interpretation of ambiguous signals, determines the presence or absence of hCG. The consumer studies then assess the "human-in-the-loop" aspect: whether lay users can correctly interpret the device's output.
7. The Type of Ground Truth Used
The ground truth for the analytical performance studies (laboratory accuracy and sensitivity) would be based on quantitative biochemical assays for human chorionic gonadotropin (hCG) levels in urine samples. This would be the definitive measure of hCG concentration, allowing for the determination of true positive and true negative samples.
For the consumer interpretation studies, the ground truth for correct interpretation would be established by comparing the consumer's visual reading of the test lines against the known analytical result (positive or negative for hCG) of the sample used.
8. The Sample Size for the Training Set
The concept of a "training set" is typically associated with machine learning or artificial intelligence models. As the "Brand Name 1-Step Pregnancy Test" is an immunochromatographic device and not an AI algorithm, there is no training set in the conventional sense. The device's characteristics are inherent to its design and chemical reagents, not learned from data.
9. How the Ground Truth for the Training Set Was Established
Since there is no training set for this type of device, this question is not applicable.
§ 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.