(130 days)
EGENS One Step HCG Urine Pregnancy Test Kit (Strip) is a rapid chromatographic immunoassay for the qualitative detection of Human Chorionin (HCG) in urine samples to aid in the early detection of pregnancy by both professional and home users.
EGENS One Step HCG Urine Pregnancy Test Kit (Cassette) is a rapid chromatographic immunoassay for the qualitative detection of Human Chorionic Gonadotrophin (HCG) in urine samples to aid in the early detection of pregnancy by both professional and home users.
EGENS One Step HCG Urine Pregnancy Test Kit (Midstream I) is a rapid chromatographic immunoassay for the qualitative detection of Human Choric Gonadotrophin (HCG) in urine samples to aid in the early detection of pregnancy by home users.
EGENS One Step HCG Urine Pregnancy Test Kit (Midstream II) is a rapid chromatographic immunoassay for the qualitative detection of Human Chorionic Gonadotrophin (HCG) in urine samples to aid in the early detection of pregnancy by home users.
One Step HCG Urine Pregnancy Test measures the presence of the hormone Human Chorionic Gonadotrophin (HCG) in human urine for the early detection of pregnancy. HCG is produced by the placenta shortly after the embryo attaches to the uterine lining. This test is capable of detecting pregnancy the first day after a missed period. As pregnancy progresses, higher levels of HCG are present in urine at concentrations of 25mlU/ml (Milli-International Units) or greater. The concentration of HCG in non-pregnant women is normally 5.0mlU/ml. At the time of the last missed menstrual period, urine HCG levels are about 100mlU/ml with peak levels of 100,000 to 200,000mlU/ml. The test devices are in four different formats: Strip, Cassette, Midstream I , and Midstream II .
The HCG assay is a rapid one-step test based on immunochromatographic technology. This device is composed of glass fiber strips of the monoclonal antibody against HCG, anti-mouse IgG, solid cellulose nitrate membrane, and the bonders of absorptive colloidal gold - monoclonal antibody against HCG. It adopts the principles of the double antibody sandwich method and imunochromatography technology to test for the presence of HCG in urine.
This document describes a regulatory submission (K123050) for the EGENS One Step HCG Urine Pregnancy Test Kit. It does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the format requested.
The document is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed performance studies against explicitly defined acceptance criteria as might be found in a clinical trial report or a standalone performance study.
Here's a breakdown of why this information is largely absent from the provided text, and what can be inferred:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated in terms of quantitative targets. The "Cut Off Values" are 25 mIU/mL, which is a key performance parameter, but not an "acceptance criterion" for a study.
- Reported Device Performance: Not provided in the form of sensitivity, specificity, accuracy, or other metrics from a clinical study. The document states that the EGENS kits "have similar technological characteristics and performances to the predicate," but no specific performance data is presented.
2. Sample Size for Test Set and Data Provenance:
- This information is not provided in the document. Substantial equivalence claims often rely on analytical performance comparisons and equivalence in design and intended use, rather than extensive clinical efficacy studies, especially for well-established diagnostic categories like HCG tests.
3. Number of Experts and Qualifications:
- This information is not applicable/not provided. The document is a regulatory submission for a medical device cleared via the 510(k) pathway, which typically does not involve human expert adjudication of results in the way, for example, an imaging AI system might.
4. Adjudication Method:
- Not applicable/not provided for the reasons stated above.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, this was not done. MRMC studies are typically for complex diagnostic tasks often involving human interpretation (e.g., radiology, pathology) where AI assistance can be quantitatively measured. This device is a simple, qualitative immunoassay.
6. Standalone (Algorithm Only) Performance Study:
- The device itself is a standalone test. However, the document does not present a formal "standalone performance study" report with metrics like sensitivity, specificity, etc. It simply describes the device's function and claims substantial equivalence. The analytical performance (e.g., limit of detection, cross-reactivity) would have been assessed by the manufacturer as part of their design validation, but these detailed results are not in this public summary.
7. Type of Ground Truth Used:
- Inferred: The ground truth for HCG tests is typically established by using known concentrations of HCG (e.g., from WHO International Standard 3rd Edition as mentioned for traceability) in urine samples, and possibly clinical correlation with documented pregnancies or absence thereof. However, the document does not explicitly state how ground truth was established for any performance evaluation.
8. Sample Size for Training Set:
- Not applicable/not provided. This device is a biochemical immunoassay, not an AI/machine learning algorithm that requires a "training set."
9. How Ground Truth for Training Set was Established:
- Not applicable/not provided for the same reasons as #8.
Summary Table (Based on what can be extracted or inferred, and explicitly noting what is missing):
| Information Category | Details from Document |
|---|---|
| 1. Table of Acceptance Criteria & Reported Device Performance | Acceptance Criteria (Key Performance Parameter): |
| Parameter | Criterion (Inferred/Stated) |
| Cut Off Value | 25 mIU/mL |
| Reported Performance: | The document states, "EGENS one step HCG urine pregnancy test kits have similar technological characteristics and performances to the predicate." No specific performance metrics (e.g., sensitivity, specificity, accuracy) from a study are provided in this summary. The substantial equivalence claim is based on matching the predicate's intended use, format, test type, specimen type, cut-off values, and traceability. |
| 2. Sample Size (Test Set) & Data Provenance | Not provided. This document does not detail a specific clinical or analytical study with a defined test set sample size or provenance. |
| 3. Number & Qualifications of Experts for Ground Truth | Not applicable/Not provided. This type of qualitative test does not typically involve human expert adjudication for ground truth and the public summary does not mention any such process. |
| 4. Adjudication Method | Not applicable/None mentioned. |
| 5. MRMC Comparative Effectiveness Study | No. This is a rapid immunoassay, not a system requiring human interpretation with or without AI assistance. |
| 6. Standalone Performance Study (Algorithm Only) | The device itself is a standalone test. However, the regulatory submission summary does not contain the detailed results of a standalone performance study (e.g., full sensitivity, specificity, or accuracy data). It relies on the claim of substantial equivalence to a predicate device. |
| 7. Type of Ground Truth Used | Inferred: Likely involved samples with known HCG concentrations (traceable to WHO International Standard 3rd Edition) and/or clinically confirmed pregnancy status. Not explicitly stated how ground truth was established for any specific performance testing referenced in the submission (if such testing results were included in the full submission, but not in this summary). |
| 8. Sample Size for Training Set | Not applicable. This device is a rapid chromatographic immunoassay, not an AI/machine learning system. |
| 9. How Ground Truth for Training Set was Established | Not applicable. |
§ 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.