(331 days)
The hCG One Step Pregnancy Test is an in vitro diagnostic test for the qualitative determination of human chorionic gonadotropin hormone in human urine samples. It is used as an aid in early detection of pregnancy, in some cases as early as five (5) days before the expected period, i.e., as early as six (6) days before the day of the missed period.
The hCG One Step Pregnancy Test is a lateral flow sandwich immunochromatographic assay for the qualitative determination of human chorionic gonadotropin (hCG) in human urine samples.
This report describes the acceptance criteria and the study that proves the device, the hCG One Step Pregnancy Test, meets those criteria.
Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed clinical study report typically associated with AI/ML-based devices. Therefore, some of the requested information, particularly regarding ground truth establishment by experts, adjudication, and MRMC studies, is not explicitly detailed as this device is a qualitative lateral flow immunoassay, not an AI-assisted diagnostic.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are demonstrated through analytical performance studies (Limit of Detection, Precision/Reproducibility, Analytical Specificity) and a comparison study to a legally marketed predicate device.
| Acceptance Criteria Category | Specific Criteria/Study Goal | Reported Device Performance |
|---|---|---|
| Analytical Performance | ||
| Limit of Detection (LOD) | Determine the lowest concentration of hCG that yields ≥ 95% positive results. The target sensitivity is 10 mIU/mL. | 10 mIU/mL for urine obtained by both simulated stream method and dip method. This was confirmed by testing serial dilutions of hCG standard substance with 3 lots of devices by 3 technicians over multiple days. At 10 mIU/mL and above, 100% positive rate was obtained. |
| Precision/Reproducibility | Show consistent results across multiple operators, lots, and days, especially at and around the LOD. | When testing hCG at 10 mIU/mL and above, a 100% positive rate was obtained for all operators with all device lots, at both the simulated stream method and the dip method. The device produced consistent results. |
| Analytical Specificity | ||
| Interfering Substances | No interference from common prescription/OTC drugs, elevated chemical analytes (caffeine, ascorbic acid), or elevated biological analytes (glucose, protein, albumin, bilirubin, hemoglobin) at relevant levels. | No interference observed from the potential interfering substances at the levels evaluated when testing negative urine samples and samples with 10 mIU/mL hCG. |
| Cross-Reactivity | No cross-reactivity with substances structurally similar to hCG. | Compounds tested (not explicitly named but implied to be similar in structure) at approximate 0 and 10 mIU/mL hCG concentrations were found to have no cross-reactivity. |
| Comparative Performance | ||
| Method Comparison | Demonstrate comparable performance to a legally marketed predicate device (First Response Early Result Pregnancy Test) using clinical urine samples. | The test performance of the hCG One Step Pregnancy Test showed 100% concordance when compared to the predicate device. This was evaluated by professional users at 2 sites using 158 clinical urine samples. |
2. Sample Sizes and Data Provenance
- Test Set Sample Size:
- Limit of Detection: The panel was created by spiking 30 negative urine samples with hCG. The number of individual test runs was significantly higher, as 3 lots of the device were tested by 3 lab technicians on different days, with randomized, blind-coded panel members. The specific total count of test runs is not provided but is a multiple of 30.
- Precision/Reproducibility: Twenty replicates of each spiked urine sample (concentrations 0, 5, 7.5, 8.75, 10, 12.5, and 25 mIU/mL) were tested in one day for repeatability. For intermediate precision, 450 replicates per urine sample concentration were tested (10 replicates per operator x 3 operators x 3 lots x 5 nonconsecutive days).
- Analytical Specificity (Interfering Substances): Five devices were used for testing each interfering substance.
- Method Comparison: A total of 158 urine samples from 158 subjects.
- Data Provenance:
- The document does not explicitly state the country of origin for the clinical urine samples.
- The studies appear to be prospective as per standard FDA premarket notification requirements for device testing. The "urine samples were collected at various times of day in a random fashion" and "masked with a code and randomized by individuals who were not conducting the test," suggesting a structured study design.
3. Number of Experts and Qualifications for Ground Truth
- This information is not explicitly detailed in the document.
- For this type of qualitative immunoassay (pregnancy test), the "ground truth" for the test set is established by the presence or absence of hCG in the urine samples at specified concentrations, verified through the spiking process using traceable hCG standards (5th WHO international Standard) and comparison to a predicate device.
- The interpretation of the device results during testing was performed by "lab technicians" for analytical studies and "professional users" for the comparison study. Their specific qualifications (e.g., years of experience, specific medical background) are not provided, but these roles imply trained personnel capable of accurately performing and interpreting the test. No expert radiologists or similar specialists are required for this device type.
4. Adjudication Method for the Test Set
- Not applicable/Not explicitly stated in the context of expert adjudication.
- For the analytical studies (LOD, Precision), the ground truth is based on the known concentration of hCG in the spiked samples. The device's performance is then measured against this known concentration.
- For the method comparison study, the comparison is made against the results of the legally marketed predicate device. Discrepancies (if any, though 100% concordance was reported) would likely prompt re-evaluation of the sample or test, rather than a formal expert adjudication process as seen in imaging studies. The samples were "masked with a code and randomized by individuals who were not conducting the test," which helps prevent bias in interpretation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not performed. This type of study is typically associated with AI/ML-based diagnostic imaging devices where human readers interpret medical images with and without AI assistance.
- The hCG One Step Pregnancy Test is a qualitative immunoassay, where the result is visually interpreted (presence/absence of a line). The "performance" is about whether the line appears correctly for a given hCG concentration, not about optimizing human interpretation of complex data.
- While multiple operators (lab technicians, professional users) were involved in testing to demonstrate reproducibility and comparability, this is distinct from an MRMC study assessing AI-assisted human reader improvement.
6. Standalone Performance (Algorithm Only)
- Yes, in essence, the device's performance is standalone.
- The hCG One Step Pregnancy Test is a non-AI, non-software-based diagnostic device. Its performance (e.g., sensitivity, specificity, limit of detection) is inherent to its physical and chemical properties and is evaluated directly through the analytical and comparison studies.
- There is no "algorithm only" component separate from the physical test strip and its reagents. The results are based on the immunochromatographic reaction itself.
7. Type of Ground Truth Used
- Analytical Ground Truth (for LOD, Precision, Analytical Specificity): Based on known concentrations of hCG in spiked urine samples, traceable to the 5th WHO international Standard. This is a highly controlled and quantitative ground truth.
- Comparative Ground Truth (for Method Comparison): The results from a legally marketed predicate device (First Response Early Result Pregnancy Test) using the same clinical urine samples. This establishes equivalence to an accepted standard.
8. Sample Size for the Training Set
- Not applicable/Not provided. This device is not an AI/ML device that requires a distinct "training set." Its chemical and biological components are designed and manufactured, not "trained" on data. The studies described are for validation and verification of the finished product's performance.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As stated above, there is no training set for this type of medical device.
§ 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.