(28 days)
FaStep Pregnancy Rapid Test Cassette is used for qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine. This test is intended for use as an aid in the early detection of pregnancy. For over-the-counter use.
The Fastep HCG Rapid Test Cassette is a rapid visual immunoassay for the qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine. This test is intended for use as an aid in the early detection of pregnancy. The test kits are for health care professionals use including professionals at physician's office labs (POLs).
The FaStep Pregnancy Rapid Test Cassette and the Fastep HCG Rapid Test Cassette are the same device with the first intended for over-the counter use and the second for prescription use. The devices contain individually wrapped pouches containing the device, instructions for use, and pipette droppers.
The devices utilize a combination of antibodies to detect hCG in urine as well as to serve as a run control. The result is displayed to the user in the test window as two lines for a 'Pregnant' positive result and one line for a 'Not Pregnant' negative result.
Here's an analysis of the acceptance criteria and study details for the FaStep Pregnancy Rapid Test Cassette and Fastep HCG Rapid Test Cassette, based on the provided document:
Acceptance Criteria and Device Performance
The document doesn't explicitly state "acceptance criteria" for all performance aspects in a separate table. However, the reported device performance implicitly defines the criteria that were met for substantial equivalence. The key performance indicators for a qualitative pregnancy test are its sensitivity (ability to detect low levels of hCG), specificity (absence of false positives), and agreement with a predicate device/professional results.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Analytical Sensitivity | Detect hCG at or below 20 mIU/mL with high positivity. | 50% Positivity (Cut-off Sensitivity): 15 mIU/mL (50.7% positive) |
| 100% Positivity: 20 mIU/mL (100% positive) | ||
| Devices consistently detected 20 mIU/mL hCG with 100% positivity across 3 lots and 3 operators. | ||
| High Dose Hook Effect | No hook effect observed at high hCG concentrations. | No hook effect observed at hCG concentrations up to 2,000,000 mIU/mL. |
| Analytical Specificity (Interfering Substances) | No interference from common substances at specified concentrations. | No interference observed from 32 listed substances (e.g., Acetaminophen, Ibuprofen, Albumin, Glucose, Hemoglobin, etc.) at their tested concentrations. |
| Analytical Specificity (Cross-reactivity) | No cross-reactivity with hLH, hFSH, hTSH at high concentrations. | No cross-reactivity observed with 500 mIU/mL hLH, 1000 mIU/mL hFSH, 1000 µIU/mL hTSH. |
| Analytical Specificity (hCG ß-core fragment) | Performance not affected by hCG ß-core fragment. | Performance not affected by hCG ß-core fragment concentrations up to 2,000,000 pmol/L. |
| Analytical Specificity (Urine pH) | Performance not affected by urine pH in the physiological range. | Urine pH ranges between 4 and 9 do not affect the performance. |
| Analytical Specificity (Urine Density) | Performance not affected by urine density in the physiological range. | Urine with a relative density range of 1.000 to 1.035 do not affect the performance. |
| Method Comparison with Predicate | 100% concordance with the predicate device. | The conformity between the test devices and the predicate device is 100% (59 positive, 53 negative, total 112 samples with 0 discordance). |
| Lay Person Study Agreement | High agreement between lay user and professional results. | Agreement between lay user results and professional user results was 100% (59 positive, 53 negative, total 112 samples with 0 discordance). The device was also determined to be "easy to use" via questionnaire. |
| False Positive Rate | Minimal to no false positive results in non-pregnant women. | 0 false positive results were observed among 300 non-pregnant females across pre-menopausal, peri-menopausal, and post-menopausal age groups (0+/100- for each group). |
2. Sample Sizes and Data Provenance
- Analytical Performance (Precision/Reproducibility/Sensitivity):
- Test Set Size: 9 hCG concentrations (0, 10, 12.5, 15, 17.5, 20, 50, 100, 200 mIU/mL) x 10 replicates/day for 5 days x 3 device lots x 3 operators = 1350 data points (for positive/negative determination).
- Data Provenance: Not explicitly stated, but typically these studies are conducted in a controlled lab environment. No country of origin is mentioned, and it's a prospective lab study.
- Hook Effect Test:
- Test Set Size: 7 hCG concentrations (25000 to 2000000 mIU/mL) x 5 replicates x 3 lots x 3 operators = 315 data points.
- Data Provenance: Prospective lab study.
- Interfering Substances:
- Test Set Size: 3 hCG concentrations (0, 10, 20 mIU/mL) x 3 replicates x 3 lots x 3 operators x 32 substances = 864 data points.
- Data Provenance: Prospective lab study.
- Cross-reactivity:
- Test Set Size: 3 hCG concentrations (0, 10, 20 mIU/mL) x 3 replicates x 3 lots x 3 operators x 3 cross-reactants = 81 data points.
- Data Provenance: Prospective lab study.
- hCG ß-core fragment:
- Test Set Size: 4 hCG concentrations (0, 10, 20, 20000 mIU/mL) x 3 replicates x 3 lots x 3 operators x 4 hCGBcf concentrations = 108 data points.
- Data Provenance: Prospective lab study.
- Urine pH:
- Test Set Size: 3 hCG concentrations (0, 10, 20 mIU/mL) x 3 replicates x 3 lots x 3 operators x 6 pH values = 162 data points.
- Data Provenance: Prospective lab study.
- Urine Density:
- Test Set Size: 3 hCG concentrations (0, 10, 20 mIU/mL) x 3 replicates x 3 lots x 3 operators x 8 density values = 216 data points.
- Data Provenance: Prospective lab study.
- Method Comparison Study:
- Test Set Size: 112 urine samples from women.
- Data Provenance: Samples collected from 112 women aged 18 to 50 at "three clinical sites." Approximately half were early-stage pregnant. Implies prospective collection for this study, likely within the US given the FDA submission.
- Lay Person Study:
- Test Set Size: 112 female subjects.
- Data Provenance: Conducted at "three sites" with females aged 18-50. Implies prospective collection for this study, likely within the US.
- Specificity Study (False Positives):
- Test Set Size: 300 urine samples from non-pregnant females (100 per age group: pre-menopausal, peri-menopausal, post-menopausal).
- Data Provenance: Samples collected from non-pregnant females at "three sites." Implies prospective collection for this study, likely within the US.
3. Number of Experts and Qualifications for Ground Truth
- Analytical Performance Studies (Sensitivity, Hook Effect, Interfering Substances, etc.): Ground truth is established by the known, spiked concentrations of hCG or other substances. The "experts" performing the tests were "operators" (3 different operators for each study involving replicates across lots), but their specific qualifications are not detailed beyond "operator." These are typically trained lab personnel.
- Method Comparison Study: The ground truth for comparative purposes was established by the predicate device results, as read by a "separate professional" at each of the three test sites. Their specific qualifications are not detailed beyond "professional."
- Lay Person Study: The ground truth was established by professional testing of the same urine samples as used by the lay users. The specific qualifications of these "professionals" are not detailed.
- Specificity Study (False Positives): The ground truth (non-pregnant status) was based on the source of the samples (non-pregnant women across different age groups). The results were read by the device itself; no explicit external expert ground truthing beyond sample collection criteria is mentioned.
4. Adjudication Method for the Test Set
- Analytical Performance Studies: No formal adjudication method like 2+1 or 3+1 is mentioned. Each replicate/lot/operator result was recorded. Discrepancies (e.g., in the sensitivity study where partial positivity was seen) were simply reported as the percentage of positive/negative readings.
- Method Comparison Study: Three professional operators read the candidate device, with a different operator at each of the three test sites. A separate professional tested samples using the predicate. It's unclear if there was any adjudication process if different professionals at the same site (if there were multiple for one device) read differently, or if discrepancies between devices were adjudicated. The results table shows perfect agreement, suggesting either no discrepancies or an unstated adjudication process.
- Lay Person Study: Lay user results were compared to "professional test results." The agreement was 100%, implying robust ground truth or an unstated adjudication process if disagreements occurred.
- Specificity Study (False Positives): No false positives were observed. Therefore, no adjudication was necessary.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study was explicitly performed to quantify human reader improvement with AI vs. without AI assistance. The device is a rapid visual immunoassay for qualitative detection of hCG and does not involve AI.
- The "Method Comparison Study" and "Lay Person Study" compare device performance to a predicate or to professional results, but not with an AI component or a quantifiable "improvement" of human readers with AI.
6. Standalone Performance
- Yes, standalone performance was extensively done. All analytical performance studies (sensitivity, hook effect, interfering substances, cross-reactivity, pH, density) evaluate the device's inherent performance.
- The "Lay Person Study" also assesses the standalone performance of the device when used by the intended over-the-counter users.
- The device is designed for qualitative visual interpretation, so its standalone performance is its primary mode of operation.
7. Type of Ground Truth Used
- Analytical Performance Studies (Precision/Sensitivity, Hook Effect, Interfering Substances, Cross-reactivity, hCG ß-core fragment, pH, Density): Ground truth was established using spiked samples with known concentrations of hCG or other substances, traceable to WHO International Standard.
- Method Comparison Study: Ground truth for comparison was the results of the predicate device.
- Lay Person Study: Ground truth was the results of professional testing of the same urine samples.
- Specificity Study (False Positives): Ground truth was the known non-pregnant status of the study participants.
8. Sample Size for the Training Set
- The document describes performance studies, which are analogous to a "test set" for demonstrating effectiveness.
- The document does not provide details about a "training set" for the device itself. This is a qualitative immunoassay, not a machine learning or AI-driven device that requires a training set in the typical sense. The manufacturing process and quality control would be "trained" or optimized during development, but this is not typically disclosed in a 510(k) summary as a "training set."
9. How the Ground Truth for the Training Set Was Established
- Since there is no explicit "training set" identified for an AI/ML context, this question is not applicable to the information provided in the document. The device's underlying chemistry and biology are its "training" or design principles.
§ 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.