(130 days)
The FaStep™ Pregnancy Rapid Test Strip is a rapid, visual immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine. The test is an in-vitro diagnostic strip intended for use as an aid in the early detection of pregnancy. The FaStep™ Pregnancy Rapid Test Strip is designed for self-testing use.
The FaStepTM Pregnancy Rapid Test Midstream is a rapid, visual immunoassay for the qualitative detection of human chorionic gonadotropin(hCG) in urine. The test is an in-vitro diagnostic device intended for use as an aid in the early detection of pregnancy. The FaStep™ Pregnancy Rapid Test Midstream is designed for self-testing use.
FaStepTM Pregnancy Rapid Test Strip is sold as a strip format and FaStepTM Pregnancy Rapid Test Midstream is sold as a midstream format. Pregnancy Rapid Test Midstream consists of a single test strip assembled in a plastic housing, with an absorbent tip, and is designed to be tested in dip or midstream mode. FaStep™ Pregnancy Rapid Test Strip is a single test strip. FaStep™ Pregnancy Rapid Test Midstream contains one test sealed in a desiccated aluminum pouch and Instructions for Use. FaStep™ Pregnancy Rapid Test Strip contains one test strip sealed in a desiccated aluminum pouch and Instructions for Use. The device is in a ready-to-use format and does not require assembly before use.
The provided text is a 510(k) Summary for the FaStep™ Pregnancy Rapid Test Strip and FaStep™ Pregnancy Rapid Test Midstream. It details the performance characteristics used to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study proving the device meets them, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a "table of acceptance criteria" with predefined numerical targets for performance metrics. Instead, it describes various studies and their outcomes, implying that the acceptance criterion for each test was a successful demonstration of performance (e.g., no false positives/negatives at specific concentrations, 100% conformity).
However, we can infer the implicit acceptance criteria from the study design and reported "100% conformity" with results from professional testing or the predicate device. The primary performance characteristic where a specific numerical sensitivity is stated is 20 mIU/mL.
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Analytical Sensitivity | 100% positive detection at 20 mIU/mL hCG. | FaStep™ Pregnancy Rapid Test Midstream (in-stream & dip) & FaStep™ Pregnancy Rapid Test Strip: At 20 mIU/mL, all 150 replicates across three operators and three lots yielded 100% positive results. At 0 and 10 mIU/mL, all 150 replicates yielded 100% negative results. The data shows a dose-response, with increasing positive rates between 12.5 mIU/mL and 17.5 mIU/mL, leading to 100% positive at 20 mIU/mL. The document explicitly states: "Based on the above results, the sensitivity of FaStep™ Pregnancy Rapid Test is demonstrated to be 20 mIU/mL." |
| Hook Effect | No hook effect observed at high hCG concentrations. | No hook effect was observed up to 500,000 mIU/mL hCG, as all tested concentrations (6,250 mIU/mL to 500,000 mIU/mL) gave a positive result. |
| Specificity | No false positive results from non-pregnant individuals. | 300 urine samples from normal, non-pregnant females across pre-menopausal, peri-menopausal, and post-menopausal groups showed no false positive results. |
| Cross-Reactivity | No interference from tested cross-reactants. | No cross-reactivity observed with 500 mIU/mL hLH, 1000 mIU/mL hFSH, and 1000 uIU/mL hTSH. No effect of hCG ß-core fragment up to 500,000 pmol/L. |
| Interfering Substances | No interference from common substances within specified levels. | No interference effect was observed at tested concentrations for a long list of substances (e.g., Acetaminophen, Acetylsalicylic Acid, Albumin, etc.), urine pH (4-9), and urine density (1.000-1.035). |
| Method Comparison | 100% conformity with predicate device. | FaStep™ Pregnancy Rapid Test Strip: 100% conformity (74 positive, 66 negative, total 140) with the predicate device. FaStep™ Pregnancy Rapid Test Midstream (in-stream method): 100% conformity (65 positive, 62 negative, total 127) with the predicate device. FaStep™ Pregnancy Rapid Test Midstream (dip method): 100% conformity (65 positive, 62 negative, total 127) with the predicate device. |
| Lay Person Study | 100% conformity with professional results and ease of use. | FaStep™ Pregnancy Rapid Test Strip: 100% conformity (74 positive, 66 negative, total 140) with professional results. FaStep™ Pregnancy Rapid Test Midstream: 100% conformity (65 positive, 62 negative, total 127) with professional results. Consumers found the test easy to use and understood the labeling and interpretation. |
2. Sample Sizes Used for the Test Set and Data Provenance
- Analytical Performance (Sensitivity/Precision/Reproducibility):
- For each hCG concentration (0, 10, 12.5, 15, 17.5, 20, 50, 100, 200 mIU/mL): 10 replicates per day for 5 days per device lot, tested by 3 operators.
- Total tests per hCG concentration per device format (Strip, Midstream in-stream, Midstream dip): 10 * 5 * 3 = 150 tests.
- Data provenance: Not explicitly stated where the urine samples were collected, but they were "spiked with hCG standard". This is a laboratory-controlled study.
- Specificity: 300 urine samples from normal, non-pregnant females (100 pre-menopausal, 100 peri-menopausal, 100 post-menopausal).
- Method Comparison Study: 267 urine samples from women presenting to test for pregnancy (139 pregnant, 128 non-pregnant - determined by predicate). Used for both FaStep™ Pregnancy Rapid Test Strip (N=140 subset) and FaStep™ Pregnancy Rapid Test Midstream (N=127 subset).
- Lay Person Study: Same sample sizes as the Method Comparison study, using the same subjects (140 for Strip, 127 for Midstream).
- Data provenance: Retrospective or prospective is not explicitly stated. The samples for the method comparison and lay person studies were "collected from women presenting to test for pregnancy," which suggests a more prospective real-world sample collection, although the overall study itself is likely a retrospective analysis of collected samples for regulatory submission. Country of origin not specified, but the submitter is from Hangzhou, China.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Analytical Performance (Sensitivity/Precision/Reproducibility): The ground truth (hCG concentration) was established by spiking with hCG standard traceable to the 5th WHO. The tests were performed by "three different operators." Their qualifications are not specified beyond being "operators." This appears to be a laboratory-controlled study rather than using clinical experts to establish ground truth.
- Specificity Study: The ground truth for specificity (non-pregnant) seems to be based on the source of the urine samples ("normal, non-pregnant female"). No explicit expert adjudication process is described for confirming this.
- Method Comparison Study: The ground truth was established by the predicate device. The text states "All samples were tested with candidate and predicate devices at three POC sites." While a predicate device serves as the reference, it's not "expert opinion."
- Lay Person Study: The ground truth was established by "professional testing." The number and qualifications of these "professionals" are not specified in the document.
4. Adjudication Method for the Test Set
- Analytical Performance: No adjudication method is explicitly stated. The results were visually read by the operators (implied), and then aggregated.
- Specificity, Cross-Reactivity, Interfering Substances, Hook Effect: These were laboratory studies with results determined by the test reactivity. No human adjudication is mentioned.
- Method Comparison and Lay Person Study: No explicit adjudication method (e.g., 2+1 or 3+1) is mentioned. The professional results (ground truth for lay person study) and predicate device results (ground truth for method comparison) appear to be taken as definitive.
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
- No, an MRMC comparative effectiveness study was NOT done. This device is a rapid, visual immunoassay for qualitative detection of hCG in urine. It is not an AI-assisted diagnostic device, nor does it involve human readers interpreting complex images or data where AI assistance would be relevant. The "lay person study" is a comparison of lay users vs. professional results for the device itself, not AI assistance for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable as this is a qualitative immunoassay test kit, not an algorithm or software. The device itself is "standalone" in that it produces a visual result directly. The "professional" testing mentioned in the lay person study implies a human interpreting the device, but the device's mechanism is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Analytical Performance (Sensitivity): Spiking with WHO traceable hCG standard.
- Specificity, Hook Effect, Cross-Reactivity, Interfering Substances: Laboratory-controlled studies using spiked samples or naturally occurring non-pregnant/specific samples, with the expected outcome (positive/negative) serving as ground truth.
- Method Comparison Study: The predicate device's results served as the ground truth.
- Lay Person Study: "Professional results" served as the ground truth. The nature of these professional results (e.g., expert interpretation of the device, or results from a laboratory reference method) is not explicitly detailed but implies a more definitive and reliable determination than the lay person's self-test.
8. The Sample Size for the Training Set
- This information is not provided. The document describes clinical and analytical performance studies (i.e., test set data) for regulatory submission, but does not detail the development or training of any underlying models, as this is a biochemical assay, not an AI/ML device requiring distinct training and test sets in the typical sense.
9. How the Ground Truth for the Training Set was Established
- Not applicable, as this is a biochemical immunoassay and does not involve AI/ML models with training sets and associated ground truth establishment methods. The document primarily focuses on validation testing and performance characteristics.
§ 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.