(151 days)
The hCG One Step Pregnancy Test Strip Rx is intended for qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in early detection of pregnancy. For in Vitro Diagnostic Use Only. For prescription use.
The hCG One Step Pregnancy Test Midstream Rx is intended for qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in early detection of pregnancy. For in Vitro Diagnostic Use Only. For prescription use.
The hCG One Step Pregnancy Test Strip OTC is intended for qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in early detection of pregnancy. For in Vitro Diagnostic Use Only. For over-the-counter use.
The hCG One Step Pregnancy Test Midstream OTC is intended for qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in early detection of pregnancy. For in Vitro Diagnostic Use Only. For over-the-counter use.
The tests are rapid, one-step lateral flow immunoassay for the qualitative detection of human chorionic gonadotropin (HCG) in urine to aid in the detection of pregnancy. The test utilizes a combination of antibodies including a monoclonal HCG antibody to selectively detect elevated levels of HCG. The assay is conducted by added urine sample and obtaining the result from the colored lines.
The tests will be sold in Midstream and Strip format. The Midstream format consists of a single test strip assembled in a plastic card, with an absorbent tip, and is designed to be tested in dip or midstream mode. The Strip format is a single test strip. The Midstream format contains one Test Midstream sealed in a desiccated aluminum foil pouch and Instructions for Use. The Strip format contains one Test strip sealed in a desiccated aluminum foil pouch, Instructions for Use. The device is in a ready-to-use format and does not require assembly before use.
The provided text describes the analytical and clinical performance of the HCG One Step Pregnancy Test Strip and Midstream (OTC and Rx) devices. It includes a comparison to a predicate device and a lay-user study.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" as a separate, pre-defined set of numerical values for all performance metrics. However, it does present performance results demonstrating the device's capabilities, which implicitly serve as the achieved criteria. The primary analytical acceptance criterion seems to be a sensitivity of 25 mIU/mL HCG and 100% agreement in clinical studies.
| Performance Metric | Acceptance Criteria (Implied by Study Design) | Reported Device Performance (Strip/Midstream) |
|---|---|---|
| Analytical Sensitivity (LoD) | 25 mIU/mL HCG: 100% positive detection | 25 mIU/mL HCG: 100% positive detection |
| Analytical Specificity | No interference from tested substances | No interference from tested LH at 500mIU/mL, FSH at 1000mIU/mL, TSH at 1mIU/mL; No interference from 20+ common substances |
| High Dose Hook Effect | No hook effect within physiological range | No hook effect up to 2,000,000 mIU/mL (2000 IU/mL) |
| Urine pH Interference | No interference from pH 4-9 | No interference from pH 4-9 |
| Urine Specific Gravity Interference | No interference from tested range | No interference from 1.000-1.035 |
| Clinical Sensitivity (vs. Predicate) | 100% agreement | 100% (Strip, Midstream Immersion, Midstream Urinate) |
| Clinical Specificity (vs. Predicate) | 100% agreement | 100% (Strip, Midstream Immersion, Midstream Urinate) |
| Clinical Accuracy (vs. Predicate) | 100% agreement | 100% (Strip, Midstream Immersion, Midstream Urinate) |
| Lay-User Positive Coincidence Rate | 100% agreement with professional results | 100% (Strip, Midstream Immersion, Midstream Urinate) |
| Lay-User Negative Coincidence Rate | 100% agreement with professional results | 100% (Strip, Midstream Immersion, Midstream Urinate) |
| Lay-User Total Coincidence Rate | 100% agreement with professional results | 100% (Strip, Midstream Immersion, Midstream Urinate) |
2. Sample size used for the test set and the data provenance
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Analytical Performance Test Set Sizes:
- Precision/Reproducibility/Sensitivity: For each device format (Strip, Midstream immersion, Midstream urinate), 90 replicates were tested at each-described HCG concentration (0, 12.5, 18.75, 25, 37.5, 50, 100 mIU/mL).
- Cross-Reactivity: For each candidate device format, n=15 for each concentration of cross-reactivity substance (LH, FSH, TSH) in each HCG level sample (0, 25, 100 mIU/mL).
- Interference Study: For each device format, 15 replicates were tested for each interferent in both negative (0 mIU/mL HCG) and positive (25 mIU/mL HCG) samples.
- HCG β-core fragment Effect: For each device format, 15 replicates were tested at each concentration of β-core fragment (62500, 125000, 50000, 1000000 pmol/L) in both negative (0 mIU/mL HCG) and positive (25 mIU/mL HCG) samples.
- Urine pH Effect: For each device format, 15 replicates were tested at various pH values (4.0, 5.0, 6.0, 7.0, 8.0, 9.0) in both negative (0 mIU/mL HCG) and positive (25 mIU/mL HCG) samples.
- Urine Specific Gravity Effect: For each device format, 15 replicates were tested at various specific gravity values (1.000, 1.025, 1.026, 1.026, 1.031, 1.035) in both negative (0 mIU/mL HCG) and positive (25 mIU/mL HCG) samples.
- High Dose Hook Effect: For each device format, 15 replicates were tested at HCG concentrations up to 2000 IU/mL.
- Read Time Flex, Temperature Flex, Sample Volume Flex, Sample Storage Study, Sample Container Material Study: Typically 5 replicates per condition for each device format.
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Clinical (Method Comparison) and Lay-User Test Set Sizes:
- Method Comparison: 330 women's urine samples.
- Strip Format: 110 samples.
- Midstream Immersion: 111 samples.
- Midstream Urinate: 109 samples.
- Lay-User Study: 330 volunteers.
- HCG One Step Pregnancy Test Strip OTC: 110 lay-users.
- HCG One Step Pregnancy Test Midstream OTC: 220 lay-users (111 for Immersion, 109 for Urinate).
- Method Comparison: 330 women's urine samples.
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Data Provenance:
- The document does not explicitly state the country of origin for the clinical samples or the analytical studies. However, the manufacturer is "Hangzhou Aichek Medical Technology Co., Ltd." in China, suggesting the data may originate from China or be collected through international collaborations.
- All clinical data appears to be prospective, collected during the method comparison and lay-user studies. The analytical studies use spiked urine samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Analytical Studies: Ground truth for analytical studies (e.g., HCG concentrations, interferent concentrations) was established by spiking known quantities of substances into urine samples. No external experts are mentioned for establishing ground truth here beyond the scientific method of solution preparation.
- Clinical (Method Comparison) Study: The ground truth was established by comparing the candidate device results to a predicate device (One Step HCG Urine Pregnancy Test - K043443). The laboratory professionals at the three point-of-care (POC) sites who performed the predicate device testing (and verified results for the lay-user study) effectively served as the "experts" for ground truth, though their specific qualifications (e.g., years of experience, specific roles) are not detailed beyond "professional testing." There were 9 different professionals in total (3 at each of 3 sites).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- The document does not describe any formal adjudication method (like 2+1 or 3+1) for resolving discrepancies between readers or devices.
- For the method comparison and lay-user studies, the comparison is directly between the candidate device's result and the predicate device's result (for method comparison) or the professional's result (for lay-user study), which implicitly serves as the ground truth without further adjudication described. Since 100% agreement was reported, no discrepancies needing adjudication were observed or reported.
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 MRMC comparative effectiveness study was done. This device is a diagnostic test kit (pregnancy test) and not an AI-assisted diagnostic tool. Therefore, the concept of "human readers improving with AI vs without AI assistance" is not applicable.
- The study involved multiple professionals (9 across 3 sites) comparing the candidate device to a predicate device, and multiple lay-users. This is a multi-reader study in a sense, but not an MRMC study designed to assess AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- This question is not applicable to HCG One Step Pregnancy Test Strips/Midstreams, as they are manual diagnostic tests with a human visually interpreting the result. They do not involve an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Analytical Studies: The ground truth for analytical studies was established by spiking known concentrations of HCG or interfering substances into negative pooled human urine samples.
- Clinical Studies (Method Comparison & Lay-User): The ground truth was established by the results obtained from the legally marketed predicate device (One Step HCG Urine Pregnancy Test - K043443), interpreted by laboratory professionals. This serves as a reference standard rather than pathology or outcomes data.
8. The sample size for the training set
- This information is not applicable. The HCG One Step Pregnancy Test is a lateral flow immunoassay, not a machine learning or AI-based device that requires a "training set" in the context of algorithm development.
9. How the ground truth for the training set was established
- This information is not applicable, as there is no "training set" for this type of 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.