(133 days)
Not Found
No
The device description and performance studies indicate a standard lateral flow immunoassay for detecting hCG, with no mention of AI or ML for interpretation or analysis.
No
This device is a pregnancy test, intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. It is an in vitro diagnostic (IVD) device, not a therapeutic device designed to treat or prevent a condition.
Yes
The device is intended for the "qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in early detection of pregnancy." This falls under the definition of a diagnostic device as it aims to identify a specific biological marker to aid in the diagnosis of a condition (pregnancy).
No
The device description clearly states it consists of a "single test strip assembled in a plastic housing, with an absorbent tip," which are physical hardware components. The testing described involves chemical reactions on this strip, not software processing of data.
Based on the provided information, the EGENS Pregnancy Test Midstream I and II devices are indeed IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use: The intended use explicitly states "for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in early detection of pregnancy". This involves testing a biological sample (urine) outside of the body to provide diagnostic information.
- Device Description: The description states the devices are used for "in vitro qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine". "In vitro" means "in glass" or "outside the body", which is a key characteristic of IVDs.
- Performance Studies: The document details various performance studies conducted on the device using urine samples, including analytical performance, specificity, cross-reactivity, and method comparison. These types of studies are standard for evaluating the performance of IVDs.
- Predicate Device: The mention of predicate devices (Wondfo One Step HCG Urine Pregnancy Test Strip, Cassette, and Midstream) with K numbers indicates that these devices are being compared to existing, cleared IVDs.
Therefore, the EGENS Pregnancy Test Midstream I and II devices fit the definition and characteristics of In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
EGENS Pregnancy Test Midstream I is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine, 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.
EGENS Pregnancy Test Midstream II is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine, 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.
Product codes
LCX
Device Description
EGENS Pregnancy Test Midstream I and EGENS Pregnancy Test Midstream II are used for in vitro qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine, and are designed to be tested in dip or midstream mode. The test device consists of a single test strip assembled in a plastic housing, with an absorbent tip. The only difference between EGENS Pregnancy Test Midstream I and EGENS Pregnancy Test Midstream II is the plastic casing. The device is in a ready-to-use format.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over the counter use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Analytical performance - Precision/Reproducibility/Sensitivity:
Negative female urine was spiked with hCG standard (Traceable to the 5th WHO) to hCG concentrations of 0, 2.5, 5, 6.5, 8, 9, 10, 15, 25 and 50 mIU/mL. Each sample was tested by both dip and midstream methods in 5 replicates per day for 5 days for each device lot. Total of three device lots were tested. Tests were performed by three different operators for each sample concentration.
Specificity and cross reactivity:
To evaluate specificity, 300 urine samples were collected from healthy, nonpregnant female in pre-menopausal (ages 1840 years old), peri-menopausal (4155 years old) and post-menopausal (>55 years old) groups. 100 people for each age group. Both dip and midstream testing are evaluated.
To evaluate cross-reactivity, negative and positive urine samples (0, 5 and 10 mIU/mL hCG) were spiked with potential cross reactants (500 mIU/mL hLH, 1000 mIU/mL hFSH, 1000 µIU/mL hTSH). These samples were tested in 30 replicates using three device lots.
To evaluate the effect of the hCG ß-core fragment, Negative urine samples (0 and 5 mIU/mL hCG) and positive urine samples (10 and 20,000 mIU/mL hCG) were spiked with hCG ß-core fragment (hCGBcf) at concentrations of 50,000 pmol/L, 125,000 pmol/L, 250,000pmol/L and 500,000pmol/L. These samples were tested in 30 replicates using three device lots.
Interfering substance:
To evaluate potential interferers with EGENS Pregnancy Test Midstream I and EGENS Pregnancy Test Midstream II, urine samples containing 0, 5 and 10 mIU/mL hCG were spiked with the interfering substance to obtain the certain desired test concentration.
To evaluate the effect of urine pH on the results of EGENS Pregnancy Test Midstream I and EGENS Pregnancy Test Midstream II, urine samples containing 0, 5 and 10 mIU/mL hCG were tested at pH values of 4, 5, 6, 7, 8 and 9.
To evaluate the effect of urine density on the results of EGENS Pregnancy Test Midstream I and EGENS Pregnancy Test Midstream II, urine samples containing 0, 5 and 10 mIU/mL hCG were tested at density values of 1.000, 1.005, 1.010, 1.015, 1.020, 1.025, 1.030 and 1.035.
Method comparison study:
A total of 206 urine samples were first collected from 206 women presenting to test for pregnancy. Of the total 206 samples, 100 samples were tested by EGENS Pregnancy Test Midstream I device and the remaining 106 samples were tested by EGENS Pregnancy Test Midstream II device. Another 100 urine samples were collected from an additional 100 women presenting to test for pregnancy. These additional 100 urine samples were tested by both EGENS Pregnancy Test Midstream I and EGENS Pregnancy Test Midstream II devices using both the in-stream method and dip method, yielding 200 testing results for each device from the additional 100 urine samples.
Lay person study:
306 women's individual pregnancy status was self-tested. Individuals with varying educational and occupational backgrounds from three sites were chosen for the study. Each subject tested her own urine sample using the device according to the package insert and provided a sample for professional testing.
Spiked urine samples were also tested by lay person. Urine samples were prepared at 5mIU/ml, 6.5mIU/ml, 8.0mIU/ml and 10mIU/ml hCG concentrations by spiking hCG into negative pooled urine specimens. Each sample was aliquoted into individual containers and blind-labeled. These samples were tested by 200 lay persons using either EGENS Pregnancy Test Midstream I or EGENS Pregnancy Test Midstream II devices.
Early Pregnancy Test Study:
Total 585 urine samples from 65 characterized cycle segments of conceptive cycles were collected from 65 pregnant women. All samples were masked and randomized.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A. Analytical performance
-
Precision/Reproducibility/Sensitivity:
- Study Type: Analytical study
- Sample Size: For each hCG concentration, 5 replicates per day for 5 days for each of 3 device lots, tested by 3 different operators. Total cells in table for each device is 150 (50 x 3 lots).
- Key Results: Sensitivity of both EGENS Pregnancy Test Midstream I and EGENS Pregnancy Test Midstream II is 10 mIU/mL.
- EGENS Pregnancy Test Midstream I results:
- 0 mIU/mL: 100% Negative
- 2.5 mIU/mL: 100% Negative
- 5 mIU/mL: 100% Negative
- 6.5 mIU/mL: 93% Negative, 7% Positive
- 8 mIU/mL: 49% Negative, 51% Positive
- 9 mIU/mL: 11% Negative, 89% Positive
- 10 mIU/mL: 0% Negative, 100% Positive
- 15, 25, 50 mIU/mL: 100% Positive
- EGENS Pregnancy Test Midstream II results:
- 0 mIU/mL: 100% Negative
- 2.5 mIU/mL: 100% Negative
- 5 mIU/mL: 100% Negative
- 6.5 mIU/mL: 94% Negative, 6% Positive
- 8 mIU/mL: 50% Negative, 50% Positive
- 9 mIU/mL: 10% Negative, 90% Positive
- 10 mIU/mL: 0% Negative, 100% Positive
- 15, 25, 50 mIU/mL: 100% Positive
- EGENS Pregnancy Test Midstream I results:
-
Linearity/assay reportable range: Linearity is not applicable as it is a qualitative test.
-
Hook effect test:
- Study Type: Analytical study
- Key Results: No hook effect was observed at hCG concentrations up to 500,000 mIU/mL. All tested concentrations (6,250 mIU/mL, 12,500 mIU/mL, 25,000 mIU/mL, 50,000 mIU/mL, 100,000 mIU/mL, 200,000 mIU/mL and 500,000 mIU/mL) yielded positive results.
-
Traceability, Stability, Expected values:
- Traceability: Calibrated against reference material traceable to WHO International Standard 5th edition, NIBSC code 07/364.
- Stability: Products in sealed foil pouch are stable for 24 months at 2 degrees C and 30 degrees C.
-
Specificity and cross reactivity:
- Study Type: Analytical study
- Key Results:
- Specificity: No false positive results were observed for any age groups (pre-menopausal, peri-menopausal, post-menopausal).
- Cross-reactivity: No cross-reactivity was observed with hLH (500 mIU/mL), hFSH (1000 mIU/mL), and hTSH (1000 µIU/mL).
- hCG ß-core fragment: Device performance is not affected by hCG ß-core fragment concentrations up to 500,000 pmol/L.
-
Interfering substance:
- Study Type: Analytical study
- Key Results: No interference effect was observed at tested concentrations for various substances. Urine pH ranges between 4 and 9 and urine density of 1.000 to 1.035 do not affect performance.
B. Method comparison study
- Study Type: Method Comparison
- Sample Size: 206 urine samples initially, plus an additional 100 urine samples (total 306). Each of the 100 additional samples yielded 2 results for each device (dip and in-stream).
- Key Results: 100% conformity between the candidate device and the predicate device.
- EGENS Pregnancy Test Midstream I (Dip): 149 total samples (74 positive, 75 negative) with 100% agreement.
- EGENS Pregnancy Test Midstream I (In-stream): 151 total samples (77 positive, 74 negative) with 100% agreement.
- EGENS Pregnancy Test Midstream II (Dip): 153 total samples (78 positive, 75 negative) with 100% agreement.
- EGENS Pregnancy Test Midstream II (In-stream): 153 total samples (76 positive, 77 negative) with 100% agreement.
C. Lay person study
- Study Type: User Performance Study
- Sample Size: 306 women for self-testing of own urine, and 200 lay persons for testing spiked urine samples.
- Key Results:
- Lay person results for EGENS Pregnancy Test Midstream I (200 samples) showed 100% positive and 100% negative conformity with professional results.
- Lay person results for EGENS Pregnancy Test Midstream II (106 samples) showed 100% positive and 100% negative conformity with professional results.
- Spiked urine sample testing:
- EGENS Pregnancy Test Midstream I:
- 5 mIU/mL: 100% agreement (0 positive, 100 negative)
- 6.5 mIU/mL: 98% agreement (5 positive, 95 negative - lay user; 7 positive, 93 negative - professional)
- 8 mIU/mL: 98% agreement (49 positive, 51 negative - lay user; 51 positive, 49 negative - professional)
- 10 mIU/mL: 100% agreement (100 positive, 0 negative)
- EGENS Pregnancy Test Midstream II:
- 5 mIU/mL: 100% agreement (0 positive, 100 negative)
- 6.5 mIU/mL: 99% agreement (6 positive, 94 negative - lay user; 7 positive, 93 negative - professional)
- 8 mIU/mL: 98% agreement (50 positive, 50 negative - lay user; 52 positive, 48 negative - professional)
- 10 mIU/mL: 100% agreement (100 positive, 0 negative)
- EGENS Pregnancy Test Midstream I:
- Questionnaire results reflected that consumers found the test easy to use and understood labeling and results.
D. Early Pregnancy Test Study
- Study Type: Early Pregnancy Detection Study
- Sample Size: 585 urine samples from 65 pregnant women (65 characterized cycle segments of conceptive cycles).
- Key Results: The new device detected 68% positive hCG five days before the Expected Menstrual Period (EMP), and 100% positive hCG on the day of EMP. No differences were observed between different device formats.
- Day relative to EMP (% cycles positive for hCG):
- EMP-8: 5%
- EMP-7: 14%
- EMP-6: 38%
- EMP-5: 69%
- EMP-4: 91%
- EMP-3: 97%
- EMP-2: 98%
- EMP-1: 100%
- EMP: 100%
- Day relative to EMP (% cycles positive for hCG):
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Sensitivity: 10 mIU/mL (analytical sensitivity)
- Specificity: 100% (based on no false positives in non-pregnant females)
- Method Comparison: 100% conformity between candidate and predicate device (agreement)
- Lay User Study: 100% positive and 100% negative conformity with professional results for self-tested samples. Agreement percentages for spiked samples ranged from 98% to 100%.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
January 26, 2024
Nantong Egens Biotechnology Co., Ltd. % Joe Shia Director LSI International 504 E Diamond Ave., Suite H Gaithersburg, Maryland 20877
Re: K232864
Trade/Device Name: EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II Regulation Number: 21 CFR 862.1155 Regulation Name: Human Chorionic Gonadotropin (HCG) Test System Regulatory Class: Class II Product Code: LCX Dated: December 26, 2023 Received: December 27, 2023
Dear Joe Shia:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Paula V. Caposino -S
Paula Caposino, Ph.D. Acting Deputy Division Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K232864
Device Name EGENS Pregnancy Test Midstream I EGENS Pregnancy Test Midstream II
Indications for Use (Describe)
EGENS Pregnancy Test Midstream I is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine, 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.
EGENS Pregnancy Test Midstream II is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine, 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.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) SUMMARY K232864
| 1. | Date: | January 22, 2024 |
|---|---|---|
| 2. | Submitter: | Nantong Egens Biotechnology Co., Ltd. |
| Building 15, 1692 Xinghu Avenue | ||
| Nantong Economy and Technology Development Zone | ||
| Nantong, Jiangsu 226010 | ||
| China | ||
| 3. | Contact person: | Joe Shia |
| LSI International Inc. | ||
| 504 East Diamond Ave., Suite H | ||
| Gaithersburg, MD 20877 | ||
| Telephone: 240-505-7880 | ||
| Fax: 301-916-6213 | ||
| Email: shiajl@yahoo.com | ||
| 4. | Device Name: | EGENS Pregnancy Test Midstream I |
| EGENS Pregnancy Test Midstream II | ||
| Classification: | ||
| Product Code: | ||
| CFR: | Class II | |
| LCX | ||
| 862.1155 | ||
| 5. | Predicate Devices: | K150022 |
| Wondfo One Step HCG Urine Pregnancy Test Strip | ||
| Wondfo One Step HCG Urine Pregnancy Test Cassette | ||
| Wondfo One Step HCG Urine Pregnancy Test Midstream |
6. Intended Use
EGENS Pregnancy Test Midstream I is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine, 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.
EGENS Pregnancy Test Midstream II is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine, 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.
Device Description 7.
EGENS Pregnancy Test Midstream I and EGENS Pregnancy Test Midstream II
4
are used for in vitro qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine, and are designed to be tested in dip or midstream mode. The test device consists of a single test strip assembled in a plastic housing, with an absorbent tip. The only difference between EGENS Pregnancy Test Midstream I and EGENS Pregnancy Test Midstream II is the plastic casing. The device is in a ready-to-use format.
| Similarities | ||
|---|---|---|
| Item | Candidate device | Predicate device |
| Intended use | A rapid chromatographic | |
| immunoassay for the | ||
| qualitative detection of | ||
| human chorionic | ||
| gonadotropin (hCG) in | ||
| urine, 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. | Same | |
| Specimen | Urine | Urine |
| Assay technical | Immunochromatographic | |
| assay | Immunochromatographic | |
| assay | ||
| Sensitivity | 10 mIU/mL | 10 mIU/mL |
| Results | Qualitative | Qualitative |
| Target user | Over the counter use | Over the counter use |
| Format | Midstream | Strip, cassette, midstream |
| Differences | ||
| Item | Device | Predicate |
| Time to result | 3-10 minutes | 5 minutes |
Substantial Equivalence Information 8.
9. Test Principle
EGENS Pregnancy Test Midstream I and EGENS Pregnancy Test Midstream II are a lateral flow chromatographic immunoassay. When the absorbent end is immersed into a sample, the sample is absorbed into the device by capillary action and mixes with the antibody-dye conjugate (mouse anti-beta HCG monoclonal antibody), flowing across the pre-coated (Goat anti HCG polyclonal antibody) membrane. During the test procedures, hCG in the urine specimen reacts with the dye conjugate and forms a complex migrates along
5
the membrane to the hCG antibody line (T), and remains captured in the T line. As a result a red colored band develops in the T line, indicating a positive result. If there is no hCG in the urine, there is no red band in the test zone, indicating a negative result. The Control line should develop in the control zone regardless of the test result. If no lines appear, or if only a red band appears in the test zone, indicating the test result is invalid.
10. Performance Characteristics
A. Analytical performance
a. Precision/Reproducibility/Sensitivity
Negative female urine was spiked with hCG standard (Traceable to the 5th WHO) to hCG concentrations of 0, 2.5, 5, 6.5, 8, 9, 10, 15, 25 and 50 mIU/mL. Each sample was tested by both dip and midstream methods in 5 replicates per day for 5 days for each device lot. Total of three device lots were tested. Tests were performed by three different operators for each sample concentration. The results summarized in the tables below are combined data for both dip and midstream testing.
| hCG
Concentration
(mIU/mL) | Lot 1 | | Lot 2 | | Lot 3 | | Total
result | | %
Negative | %
Positive |
|----------------------------------|-------|----|-------|----|-------|----|-----------------|-----|---------------|---------------|
| | - | + | - | + | - | + | - | + | | |
| 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0 | 100% | 0% |
| 2.5 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0 | 100% | 0% |
| 5 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0 | 100% | 0% |
| 6.5 | 47 | 3 | 46 | 4 | 47 | 3 | 140 | 10 | 93% | 7% |
| 8 | 25 | 25 | 22 | 28 | 27 | 23 | 74 | 76 | 49% | 51% |
| 9 | 7 | 43 | 5 | 45 | 4 | 46 | 16 | 134 | 11% | 89% |
| 10 | 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0% | 100% |
| 15 | 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0% | 100% |
| 25 | 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0% | 100% |
| 50 | 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0% | 100% |
EGENS Pregnancy Test Midstream I
EGENS Pregnancy Test Midstream II
| hCG
Concentration
(mIU/mL) | Lot 1 | | Lot 2 | | Lot 3 | | Total
result | | %
Negative | %
Positive |
|----------------------------------|-------|----|-------|----|-------|----|-----------------|----|---------------|---------------|
| | - | + | - | + | - | + | - | + | | |
| 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0 | 100% | 0% |
| 2.5 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0 | 100% | 0% |
| 5 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0 | 100% | 0% |
| 6.5 | 48 | 2 | 47 | 3 | 46 | 4 | 141 | 9 | 94% | 6% |
| 8 | 27 | 23 | 24 | 26 | 24 | 26 | 75 | 75 | 50% | 50% |
6
| 9 | 5 | 45 | 3 | 47 | 7 | 43 | 15 | 135 | 10% | 90% |
|---|---|---|---|---|---|---|---|---|---|---|
| 10 | 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0% | 100% |
| 15 | 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0% | 100% |
| 25 | 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0% | 100% |
| 50 | 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0% | 100% |
EGENS Pregnancy Test Midstream I and EGENS Pregnancy Test Midstream II exhibited reproducible results.
Based on the above results, the sensitivity of EGENS Pregnancy Test Midstream I and EGENS Pregnancy Test Midstream II are both demonstrated to be 10mIU/mL.
b. Linearity/assay reportable range:
Linearity is not applicable since this is a qualitative test. The test device was evaluated for high dose or hook effect.
c. Hook effect test:
Negative urine samples were spiked with varying hCG concentrations (6,250 mIU/mL, 12,500 mIU/mL, 25,000 mIU/mL, 50,000 mIU/mL, 100,000 mIU/mL, 200,000 mIU/mL and 500,000 mIU/mL). All tested concentrations gave a positive result. The results demonstrated that no hook effect was observed at hCG concentration up to 500,000 mIU/mL.
d. Traceability, Stability, Expected values (controls, calibrators, or methods): Traceability:
EGENS Pregnancy Test Midstream I and EGENS Pregnancy Test Midstream II are calibrated against reference material traceable to WHO International Standard 5th edition, NIBSC code 07/364.
Stability:
Products in sealed foil pouch are stable for 24 months at 2℃ and 30℃, based on the real time stability study.
e. Specificity and cross reactivity
To evaluate specificity, 300 urine samples were collected from healthy, nonpregnant female in pre-menopausal (ages 1840 years old), peri-menopausal (4155 years old) and post-menopausal (>55 years old) groups. 100 people for each age group. Both dip and midstream testing are evaluated. No false positive results were observed for any of the age groups.
To evaluate cross-reactivity, negative and positive urine samples (0, 5 and 10 mIU/mL hCG) were spiked with potential cross reactants (500 mIU/mL hLH, 1000 mIU/mL hFSH, 1000 µIU/mL hTSH). These samples were tested in 30 replicates using three device lots. No cross-reactivity was observed at tested concentration. To evaluate the effect of the hCG ß-core fragment, Negative urine samples (0 and
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5 mIU/mL hCG) and positive urine samples (10 and 20,000 mIU/mL hCG) were spiked with hCG ß-core fragment (hCGBcf) at concentrations of 50,000 pmol/L, 125,000 pmol/L, 250,000pmol/L and 500,000pmol/L. These samples were tested in 30 replicates using three device lots. The device performance is not affected by hCG ß-core fragment concentrations up to 500,000 pmol/L.
f. Interfering substance
To evaluate potential interferers with EGENS Pregnancy Test Midstream I and EGENS Pregnancy Test Midstream II, urine samples containing 0, 5 and 10 mIU/mL hCG were spiked with the interfering substance to obtain the certain desired test concentration. No interference effect was observed at the tested concentration shown in table below:
| Substance | Concentration |
|---|---|
| Acetaminophen | 20 mg/dL |
| Acetylsalicylic | 20 mg/dL |
| Ascorbic acid | 20 mg/dL |
| Atropine | 20 mg/dL |
| Caffeine | 20 mg/dL |
| Gentisic acid | 20 mg/dL |
| Glucose | 2 g/dL |
| Hemoglobin | 20 mg/dL |
| Tetracycline | 20 mg/dL |
| Ampicillin | 20 mg/dL |
| Albumin | 20 mg/dL |
| β-hydroxybutyrate | 2000 mg/dL |
| Ephedrine | 20 mg/dL |
| Phenylpropanolamine | 20 mg/dL |
| Phenothiazine | 20 mg/dL |
| EDTA | 80 mg/dL |
| Salicyclic Acid | 20 mg/dL |
| Benzoylecgonine | 10 mg/dL |
| Cannabinol | 10 mg/dL |
| Codeine | 6ug/dL |
| Ethanol | 1.0% |
| Bilirubin | 2mg/dL |
| Pregnanediol | 1500µg/dL |
| Thiophene | 20 mg/dL |
| Ketone | 20 mg/dL |
To evaluate the effect of urine pH on the results of EGENS Pregnancy Test Midstream I and EGENS Pregnancy Test Midstream II, urine samples containing 0, 5 and 10 mIU/mL hCG were tested at pH values of 4, 5, 6, 7, 8 and 9. The results indicated that urine pH ranges between 4 and 9 does not affect the performance of EGENS Pregnancy Test Midstream I and EGENS Pregnancy
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Test Midstream II.
To evaluate the effect of urine density on the results of EGENS Pregnancy Test Midstream I and EGENS Pregnancy Test Midstream II, urine samples containing 0, 5 and 10 mIU/mL hCG were tested at density values of 1.000, 1.005, 1.010, 1.015, 1.020, 1.025, 1.030 and 1.035. The results indicated that urine with a relative density of 1.000 to 1.035 does not affect the performance of EGENS Pregnancy Test Midstream I and EGENS Pregnancy Test Midstream II.
B. Method comparison study
Method comparison with predicate device
The performance of the new device was compared to the predicate test. A total of 206 urine samples were first collected from 206 women presenting to test for pregnancy. Of the total 206 samples, 100 samples were tested by EGENS Pregnancy Test Midstream I device and the remaining 106 samples were tested by EGENS Pregnancy Test Midstream II device. Another 100 urine samples were collected from an additional 100 women presenting to test for pregnancy. These additional 100 urine samples were tested by both EGENS Pregnancy Test Midstream I and EGENS Pregnancy Test Midstream II devices using both the in-stream method and dip method, yielding 200 testing results for each device from the additional 100 urine samples. Test results showed 100% conformity between the candidate device and the predicate device.
| EGENS Pregnancy Test
| Midstream I (Dip) | Predicate device | |||
|---|---|---|---|---|
| Positive | Negative | Total | ||
| Candidate device | Positive | 74 | 0 | 74 |
| Negative | 0 | 75 | 75 | |
| Total | 74 | 75 | 149 |
Summary EGENS Pregnancy Test Midstream I Testing Results
| EGENS Pregnancy Test
| Midstream I (In-stream) | Predicate device | |||
|---|---|---|---|---|
| Positive | Negative | Total | ||
| Candidate device | Positive | 77 | 0 | 77 |
| Negative | 0 | 74 | 74 | |
| Total | 77 | 74 | 151 |
Summary EGENS Pregnancy Test Midstream II Testing Results
| EGENS Pregnancy Test
| Midstream II (Dip) | Predicate device | |||
|---|---|---|---|---|
| Positive | Negative | Total | ||
| Candidate device | Positive | 78 | 0 | 78 |
| Negative | 0 | 75 | 75 | |
| Total | 78 | 75 | 153 |
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| EGENS Pregnancy Test
| Midstream II (In-stream) | Positive | Negative | Total | |
|---|---|---|---|---|
| Candidate device | Positive | 76 | 0 | 76 |
| Negative | 0 | 77 | 77 | |
| Total | 76 | 77 | 153 |
C. Lay person study
306 women's individual pregnancy status was self-tested. Individuals with varying educational and occupational backgrounds from three sites were chosen for the study. Each subject tested her own urine sample using the device according to the package insert and provided a sample for professional testing.
Summary
| EGENS Pregnancy Test
Midstream I
| (in-stream or dip method) | Professional Result | Total | ||
|---|---|---|---|---|
| Positive | Negative | |||
| Lay user Result | Positive | 101 | 0 | 101 |
| Negative | 0 | 99 | 99 | |
| Total | 101 | 99 | 200 |
| EGENS Pregnancy Test
Midstream II
| (in-stream or dip method) | Professional Result | Total | ||
|---|---|---|---|---|
| Positive | Negative | |||
| Lay user Result | Positive | 54 | 0 | 54 |
| Negative | 0 | 52 | 52 | |
| Total | 54 | 52 | 106 |
From the above tables, the lay person results showed 100% positive and 100% negative conformity with the professional results.
Spiked urine samples were also tested by lay person. Urine samples were prepared at 5mIU/ml, 6.5mIU/ml, 8.0mIU/ml and 10mIU/ml hCG concentrations by spiking hCG into negative pooled urine specimens. Each sample was aliquoted into individual containers and blind-labeled. These samples were tested by 200 lay persons using either EGENS Pregnancy Test Midstream I or EGENS Pregnancy Test Midstream II devices.
For EGENS Pregnancy Test Midstream I
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| Number
of samples | hCG
concentration
(mIU/mL) | Lay user result | | Professional Result | | Percent
Agreement |
|----------------------|----------------------------------|-----------------------|-----------------------|-----------------------|-----------------------|----------------------|
| | | Number
of positive | Number
of negative | Number
of positive | Number of
negative | |
| 100 | 5 | 0 | 100 | 0 | 100 | 100% |
| 100 | 6.5 | 5 | 95 | 7 | 93 | 98% |
| 100 | 8 | 49 | 51 | 51 | 49 | 98% |
| 100 | 10 | 100 | 0 | 100 | 0 | 100% |
For EGENS Pregnancy Test Midstream II
| Number
of samples | hCG
concentration
(mIU/mL) | Lay user result | | Professional Result | | Percent
Agreement |
|----------------------|----------------------------------|-----------------|-----|---------------------|-----|----------------------|
| 100 | 5 | 0 | 100 | 0 | 100 | 100% |
| 100 | 6.5 | 6 | 94 | 7 | 93 | 99% |
| 100 | 8 | 50 | 50 | 52 | 48 | 98% |
| 100 | 10 | 100 | 0 | 100 | 0 | 100% |
Each lay person was given a questionnaire to assess the readability of the labeling. The results of the questionnaire reflected that the consumers found the test easy to use and that they did not have trouble understanding the labeling and interpreting the results.
D. Early Pregnancy Test Study
In this study, total 585 urine samples from 65 characterized cycle segments of conceptive cycles were collected from 65 pregnant women. All samples were masked and randomized. Each sample was tested by two formats of the device. The new device detected 68% positive hCG five days before the
Expected Menstrual Period (EMP), and 100% positive hCG on the day of EMP. No differences were observed between different device formats. The following table is the summary of the data.
| Day relative to EMP | EMP-8 | EMP-7 | EMP-6 | EMP-5 | EMP-4 | EMP-3 | EMP-2 | EMP-1 | EMP |
|---|---|---|---|---|---|---|---|---|---|
| # of cycles positive for hCG | 3/65 | 9/65 | 25/65 | 45/65 | 59/65 | 63/65 | 64/65 | 65/65 | 65/65 |
| % cycles positive for hCG | 5% | 14% | 38% | 69% | 91% | 97% | 98% | 100% | 100% |
11. Conclusion
Based on the test principle and performance characteristics of the device
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including precision, cut-off, interference, specificity, method comparison and lay-user studies of the device, it's concluded that EGENS Pregnancy Test Midstream I and EGENS Pregnancy Test Midstream II are substantially equivalent to the predicate.