(34 days)
The Brand Name 1-Step Pregnancy Test is a simple-to-use at-home pregnancy test marketed over-the-counter (OTC) to lay consumers. The test device product is intended for the detection of human chorionic gonadotropin (hCG) in urine as an aid in the detection of early pregnancy.
The Brand Name 1 -Step Pregnancy Test is a Class II in vitro diagnostic medical device product that functions by way of an immunochemical chromatographic-chromogenic method in detecting the presence of hCG in the urine as an aid in the early diagnosis of pregnancy. It consists of a plastic stick, housing an absorbent pad that collects and delivers urine to reagents on a chromatographic strip contained within the device. The test is performed by placing the absorbent pad of the device in the urine stream for 5 seconds or by dipping the device 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 in the urine sample (pregnant) 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.
This document is a 510(k) summary for a pregnancy test, not an AI/ML medical device. Therefore, many of the requested fields (e.g., sample sizes for test and training sets, expert qualifications, MRMC studies, ground truth establishment for AI) are not applicable.
Here's the information that can be extracted and a clear indication of what is not applicable to this type of device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated Requirements) | Reported Device Performance |
|---|---|
| Sensitivity (Detection of hCG) | Not explicitly stated in the provided text, but implied by the successful detection of hCG in clinical studies. |
| Specificity (Absence of hCG) | Not explicitly stated in the provided text, but implied by the differentiation of pregnant/non-pregnant women. |
| Accuracy (Overall agreement) | Overall Agreement: 99.4% (98.6% - 100%) |
| User Comprehension/Interpretation | Accuracy of User Interpretation (Lay Users): 99% (97.7%-99.7%) |
| Comparison to Predicate | Substantially equivalent to One-Step CLEARBLUE Easy™ Pregnancy Test. |
Study Details (as applicable for this device type):
2. Sample size used for the test set and the data provenance:
- Sample Size (Clinical Study): 78 pregnant and 58 non-pregnant subjects (Total = 136 subjects)
- Data Provenance: Not explicitly stated, but clinical studies are generally prospective. The text implies a real-world setting with "lay consumers."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For a pregnancy test, the ground truth (pregnancy status) is established by other definitive clinical methods (e.g., physician-confirmed pregnancy via other assays or ultrasound), not typically by expert review of the test device's output. The "Expert" column in the table refers to the expert reading of the brand-name device and predicate device, likely by trained laboratory personnel or clinicians, not experts establishing the true pregnancy status.
4. Adjudication method for the test set:
- Adjudication Method: Not explicitly stated. For the clinical study table, results were compared between the Brand Name device, the predicate device, and "Expert" readings of both. It's unclear if there was an adjudication process for discordant results between the expert readings and the clinical predicate, or if "Expert" refers to the confirmed pregnancy status. Given the nature of a pregnancy test, the "ground truth" would be established by independent clinical means.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This is not an AI-powered device. The study involved lay users and expert readers for the device itself, but not in the context of an AI-assisted workflow.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a diagnostic medical device that provides a visual readout. Its performance is its standalone performance, and ultimately relies on human interpretation (either lay users or experts). There is no "algorithm only" component separate from the physical test strip.
7. The type of ground truth used:
- Type of Ground Truth: The ground truth for pregnancy status was established by independent clinical confirmation (likely via a combination of physician diagnosis, other laboratory tests for hCG, etc.), as indicated by the comparison with "Clinically Confirmed Pregnant" and "Clinically Confirmed Not Pregnant" categories in the lay user study description. For the clinical study, the expert reading of the predicate device and the new device were compared.
8. The sample size for the training set:
- Not Applicable. This device does not use machine learning or AI, and therefore does not have a "training set" in that context. The device's design and manufacturing process are established through traditional engineering and quality control, not data-driven model training.
9. How the ground truth for the training set was established:
- Not Applicable. As there is no training set for an AI model, this question is not relevant.
§ 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.