(197 days)
Not Found
No
The device description and performance studies indicate a standard lateral flow immunoassay, with no mention of AI/ML components or related data analysis techniques.
No.
The device is a diagnostic tool used to detect conditions (pregnancy) but does not treat or prevent them.
Yes
The device is described as aiding in the early detection of pregnancy by detecting hCG in urine, which is a diagnostic purpose.
No
The device description clearly states it is a lateral flow immunoassay sold in physical formats (Strip, Cassette, Midstream) containing test devices and other physical components, indicating it is a hardware-based medical device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states the device is for the "qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy." This involves testing a biological sample (urine) in vitro (outside the body) to obtain diagnostic information.
- Device Description: The description details a "test device" that performs a "lateral flow immunoassay." Immunoassays are a common type of in vitro diagnostic test.
- Performance Studies: The document describes various analytical and clinical performance studies conducted on the device using urine samples. This is typical for IVD devices to demonstrate their accuracy and reliability.
- Method Comparison Study: The comparison to a "predicate test" (another IVD device) further confirms its classification as an IVD.
- Lay Person Study: The study involving self-testing by women using their urine samples reinforces its use as a diagnostic tool.
The core function of the device is to analyze a biological sample (urine) in vitro to provide information about a physiological state (pregnancy), which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SEIOY hCG One Step Pregnancy Test Strip is a rapid, one-step lateral flow immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. The SEJOY hCG One Step Pregnancy Test Cassette is a rapid, one-step lateral flow immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy.
The SEJOY hCG One Step Pregnancy Test Midstream is a rapid, one-step lateral flow immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy.
Product codes (comma separated list FDA assigned to the subject device)
LCX
Device Description
Sejoy HCG One Step Pregnancy Test will be sold in three different formats:Strip,Cassette,and Midstream.The Test Strip and Midstream format contain a test device sealed in a desiccated aluminum pouch and a package insert. The Cassette format contains one test device,a disposable plastic dropper,and a package insert.
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
For the analytical performance study (Precision/Reproducibility/Sensitivity), "Negative urine was spiked with hCG standard (Traceable to the 5th WHO) to hCG concentrations of 0, 12.5, 18.75, 22.5, 25, 50, 100 and 200mIU/mL.The spiked samples were measured in replicates using 3 different lots for each format.Tests were performed by three different operators for each sample concentration in 2 runs per day for 15 days."
For the method comparison study, "For strip and cassette format,urine samples were collected from 150 women presenting to test for pregnancy. Approximately half of the 150 women were suspected to be pregnant. For midstream format,urine samples were collected from 135 women presenting to test for pregnancy. Approximately half of the 135 women were suspected to be pregnant." All samples were tested by three different health professionals for each format at the 3 POC sites for a total of 12 POC operators with the proposed and the predicate devices.
For the lay person study, "440 women's individual pregnancy status was self-tested, varying educational and occupational backgrounds 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 of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Analytical Performance (Precision/Reproducibility/Sensitivity):
Negative urine spiked with hCG standards (0, 12.5, 18.75, 22.5, 25, 50, 100, 200 mIU/mL).
Samples measured in replicates using 3 different lots for each format (Strip, Cassette, Midstream).
Tests performed by three different operators for each sample concentration in 2 runs per day for 15 days.
Key results: For 25, 50, 100, and 200 mIU/mL hCG concentrations, the positive compliance rate was 100% across all formats and operators. For 0 and 12.5 mIU/mL hCG concentrations, the negative compliance rate was 100% across all formats and operators. At 18.75 and 22.5 mIU/mL, there was mixed compliance, with 22.5 mIU/mL showing approximately 50-50 split between negative and positive compliance.
Hook effect test:
Negative urine samples spiked with varying hCG concentrations up to 2000 IU/mL. All tested concentrations gave a positive result, demonstrating no hook effect up to 2000 U/mL.
Cross-reactivity:
Evaluated with LH (500mIU/mL), FSH (1000mIU/mL), TSH (1000mIU/L), and hCG ß-core fragment (2000,000pmol/L) in negative, 10 mIU/mL positive, and 25 mIU/mL positive urine samples. No cross-reaction observed.
Interfering substance:
Screened against various exogenous compounds (e.g., Acetaminophen, Ascorbic Acid, Caffeine, Ethanol, Albumin, Glucose, Bilirubin, Hemoglobin) in negative, 10 mIU/mL positive, and 25 mIU/mL positive hCG samples. No interferences observed.
Effect of urine pH:
Tested with negative, 10 mIU/mL positive, and 25 mIU/mL positive hCG urine samples at pH values of 4, 5, 6, 7, 8, and 9. No interference observed within the pH range of 4-9 for either positive or negative results.
Effect of Specific Gravity:
Tested with negative, 12.5 mIU/mL, and 25 mIU/mL hCG samples adjusted to specific gravities of 1.000, 1.012, 1.020, 1.030, 1.037. No interference observed in samples with specific gravity ranging from 1.000-1.037.
Method Comparison Study with Predicate Device:
Strip and Cassette formats: 150 urine samples each (approx. half suspected pregnant).
Midstream format: 135 urine samples (approx. half suspected pregnant).
All samples tested by three different health professionals/POC operators (12 total) using both the proposed and predicate devices.
Key results:
Strip format: 72 Negative detections, 78 Positive detections.
Cassette format: 72 Negative detections, 78 Positive detections.
Midstream format (dip method): 72 Negative detections, 63 Positive detections.
Midstream format (simulate stream method): 72 Negative detections, 63 Positive detections.
Conclusion: The average positive conformity rate of Rapid Pregnancy Test is 100%. The average negative conformity rate of Rapid Pregnancy Test is 100%.
Lay person study:
440 women self-tested their urine samples using the device. A professional also tested the same samples.
Key results:
Strip format: Lay person positive (46), Professional positive (46); Lay person negative (64), Professional negative (64).
Cassette format: Lay person positive (44), Professional positive (44); Lay person negative (66), Professional negative (66).
Midstream format (dip method): Lay person positive (42), Professional positive (42); Lay person negative (68), Professional negative (68).
Midstream format (simulate stream method): Lay person positive (45), Professional positive (45); Lay person negative (65), Professional negative (65).
Conclusion: The lay person results showed 100% positive and 100% negative conformity with the professional results. Consumers found the test easy to use and understood the labeling and results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity (Analytical): 25 mIU/mL
For method comparison study, The average positive conformity rate of Rapid Pregnancy Test is 100%. The average negative conformity rate of Rapid Pregnancy Test is 100%.
For lay person study, 100% positive and 100% negative conformity with the professional results.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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February 18, 2022
Hangzhou Sejoy Electronics & Instruments Co., Ltd. Yanyan Zhang Regulation Affair Area C, Building 2, No.365 Hangzhou, Zhejiang 311100 China
Re: K212447
Trade/Device Name: SEJOY hCG One Step Pregnancy Test Strip, SEJOY hCG One Step Pregnancy Test Cassette, SEJOY hCG One Step Pregnancy Test Midstream Regulation Number: 21 CFR 862.1155 Regulation Name: Human Chorionic Gonadotropin (HCG) Test System Regulatory Class: Class II Product Code: LCX Dated: November 18, 2021 Received: November 23, 2021
Dear Yanyan Zhang:
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 (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 located 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.
1
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 (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 medical devices and radiation-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.
Marianela Perez-Torres, Ph.D. Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212447
Device Name
SEJOY hCG One Step Pregnancy Test Strip SEJOY hCG One Step Pregnancy Test Cassette SEJOY hCG One Step Pregnancy Test Midstream
Indications for Use (Describe)
The SEIOY hCG One Step Pregnancy Test Strip is a rapid, one-step lateral flow immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. The SEJOY hCG One Step Pregnancy Test Cassette is a rapid, one-step lateral flow immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy.
The SEJOY hCG One Step Pregnancy Test Midstream is a rapid, one-step lateral flow immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
510(k) number:K212447
1. Contact Details
| Applicant Name | Hangzhou Sejoy Electronics & Instruments Co., Ltd. |
|---|---|
| Address | Area C,Building 2,No.365,Hangzhou City,311100 Zhejiang,China |
| Phone No. | +86 571-81957767 |
| Fax. | +86 571-8195 7750 |
| Contact person | Yanyan Zhang |
| Date Prepared | February 09, 2022 |
| Website | http://www.sejoy.com |
2. Device information
| Trade name | SEJOY hCG One Step Pregnancy Test Strip
SEJOY hCG One Step Pregnancy Test Cassette
SEJOY hCG One Step Pregnancy Test Midstream |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Format | Strip,Cassette,Midstream |
| Classification | 2 |
| Classification name | Kit, Test, Pregnancy, Hcg, Over The Counter |
| 510(k) Number | K212447 |
| Product code | LCX |
| Regulation No. | 862.1155 |
3. Legally Marketed Predicate Device
| Trade Name | CLUNGENE HCG Pregnancy Rapid Test Cassette,
CLUNGENE HCG Pregnancy Rapid Test Strip,
CLUNGENE HCG Pregnancy Rapid Test Midstream |
|---------------|----------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K193132 |
| Product Code | LCX |
| Manufacturer | Hangzhou Clongene Biotech Co.,Ltd. |
4. Device Description
Sejoy HCG One Step Pregnancy Test will be sold in three different formats:Strip,Cassette,and Midstream.The Test Strip and Midstream format contain a test device sealed in a desiccated aluminum pouch and a package insert. The Cassette format contains one test device,a disposable plastic dropper,and a package insert.
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Image /page/4/Picture/0 description: The image shows the word "SEJOY" in blue, with a small yellow triangle above the "J". The font is bold and sans-serif. A small "R" in a circle is located to the bottom right of the word.
5. Intended Use/Indication for Use
The Sejoy hCG One Step Pregnancy Test Strip is a rapid, one-step lateral flow immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy.
The Sejoy hCG One Step Pregnancy Test Cassette is a rapid, one-step lateral flow immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy.
The Sejoy hCG One Step Pregnancy Test Midstream is a rapid,one-step lateral flow immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy.
| Item | Proposed Device:
SEJOY HCG One Step
Pregnancy Test | Predicate Device:
(K193132) |
|-------------------------------------|----------------------------------------------------------|-----------------------------------|
| Regulation number | 862.1155 | 862.1155 |
| Classification | 2 | 2 |
| Product Code | LCX | LCX |
| Intended use/Indications
for use | Aid in the detection of pregnancy | Aid in the detection of pregnancy |
| Methodology | Immunochromatographic
assay | Immunochromatographic
assay |
| Sensitivity | 25 mIU/mL | 25 mIU/mL |
| Specimen | Urine | Urine |
| Results | Qualitative | Qualitative |
| Target user | Over the counter use | Over the counter use |
| Device format | Strip,Cassette,Midstream | Strip,Cassette,Midstream |
| Reading Time | 3-5 minutes | 3 minute |
6. Substantial Equivalence Comparison
7. Standard/Guidance Document Reference (if applicable)
Guidance for Over-the-Counter (OTC) Human Chorionic Gonadotropin (hCG) 510(k)s, July 22, 2000
8. Test Principle
This device operates by detecting human chorionic gonadotropin (hCG), the hormone produced during pregnancy in urine,using a lateral flow sandwich immunochromatographic assay.
9. Performance Characteristics
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A. Analytical performance
a. Precision/Reproducibility/Sensitivity
Negative urine was spiked with hCG standard (Traceable to the 5th WHO) to hCG concentrations of 0, 12.5, 18.75, 22.5, 25, 50, 100 and 200mIU/mL.The spiked samples were measured in replicates using 3 different lots for each format.Tests were performed by three different operators for each sample concentration in 2 runs per day for 15 days. The results are summarized in the table below:
Operator 1:
| hCG
Concentration
(mIU/mL) | hCG190401 | | hCG190402 | | hCG190403 | | The total of
the results | | Negative
compliance rate
(%) | Positive
compliance Rate
(%) |
|----------------------------------|-----------|----|-----------|----|-----------|----|-----------------------------|----|------------------------------------|------------------------------------|
| | - | + | - | + | - | + | - | + | | |
| 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 | 0 |
| 12.5 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 | 0 |
| 18.75 | 25 | 5 | 26 | 4 | 23 | 7 | 74 | 16 | 82.2 | 17.8 |
| 22.5 | 18 | 12 | 16 | 14 | 13 | 17 | 47 | 43 | 52.2 | 47.8 |
| 25 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
| 50 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
| 100 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
| 200 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
Strip Format
Cassette Format
| hCG
Concentration
(mIU/mL) | hCG190501 | | hCG190502 | | hCG190503 | | The total of
the results | | Negative
compliance rate
(%) | Positive compliance
Rate
(%) |
|----------------------------------|-----------|----|-----------|----|-----------|----|-----------------------------|----|------------------------------------|------------------------------------|
| | - | + | - | + | - | + | - | + | | |
| 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 | 0 |
| 12.5 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 | 0 |
| 18.75 | 23 | 7 | 26 | 4 | 24 | 6 | 73 | 17 | 81.1 | 18.9 |
| 22.5 | 17 | 13 | 15 | 15 | 14 | 16 | 46 | 44 | 51.1 | 48.9 |
| 25 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
| 50 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
| 100 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
| 200 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
Midstream Format
| hCG
Concentration | hCG190601 | hCG190602 | hCG190603 | The total of
the results | Negative
compliance rate | Positive compliance
Rate |
| ---------------------- | ----------- | ----------- | ----------- | ----------------------------- | ----------------------------- | ----------------------------- |
|---|
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| (mIU/mL) | - | + | - | + | - | + | - | + | (%) | (%) |
|---|---|---|---|---|---|---|---|---|---|---|
| 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 | 0 |
| 12.5 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 | 0 |
| 18.75 | 26 | 4 | 26 | 4 | 24 | 6 | 76 | 14 | 84.4 | 15.6 |
| 22.5 | 16 | 14 | 16 | 14 | 16 | 14 | 48 | 42 | 53.3 | 46.7 |
| 25 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
| 50 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
| 100 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
| 200 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
Operator 2:
Strip Format
| hCG
Concentration
(mIU/mL) | hCG190401 | | hCG190402 | | hCG190403 | | The total of
the results | | Negative
compliance rate
(%) | Positive compliance
Rate
(%) |
|----------------------------------|-----------|----|-----------|----|-----------|----|-----------------------------|----|------------------------------------|------------------------------------|
| | - | + | - | + | - | + | - | + | | |
| 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 | 0 |
| 12.5 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 | 0 |
| 18.75 | 22 | 8 | 25 | 5 | 25 | 5 | 72 | 18 | 80.0 | 20 |
| 22.5 | 18 | 12 | 16 | 14 | 13 | 17 | 47 | 43 | 52.2 | 47.8 |
| 25 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
| 50 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
| 100 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
| 200 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
Cassette Format
| hCG
Concentration
(mIU/mL) | hCG190501 | | hCG190502 | | hCG190503 | | The total of
the results | | Negative
compliance rate
(%) | Positive compliance
Rate
(%) |
|----------------------------------|-----------|----|-----------|----|-----------|----|-----------------------------|----|------------------------------------|------------------------------------|
| | - | + | - | + | - | + | - | + | | |
| 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 | 0 |
| 12.5 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 | 0 |
| 18.75 | 24 | 6 | 23 | 7 | 25 | 5 | 72 | 18 | 80.0 | 20 |
| 22.5 | 16 | 14 | 14 | 16 | 16 | 14 | 46 | 44 | 51.1 | 48.9 |
| 25 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
| 50 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
| 100 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
| 200 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
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Midstream Format
| hCG
Concentration | hCG190601 | | hCG190602 | | hCG190603 | | The total of
the results | | Negative
compliance rate | Positive compliance
Rate |
|----------------------|-----------|----|-----------|----|-----------|----|-----------------------------|----|-----------------------------|-----------------------------|
| (mIU/mL) | - | + | - | + | - | + | - | + | (%) | (%) |
| 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 | 0 |
| 12.5 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 | 0 |
| 18.75 | 25 | 5 | 24 | 6 | 24 | 6 | 73 | 17 | 81.1 | 18.9 |
| 22.5 | 15 | 15 | 14 | 16 | 18 | 12 | 47 | 43 | 52.2 | 47.8 |
| 25 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
| 50 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
| 100 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
| 200 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
Operator 3:
Strip Format
| hCG
Concentration
(mIU/mL) | hCG190401 | | hCG190402 | | hCG190403 | | The total of
the results | | Negative
compliance rate
(%) | Positive compliance
Rate
(%) |
|----------------------------------|-----------|----|-----------|----|-----------|----|-----------------------------|----|------------------------------------|------------------------------------|
| | - | + | - | + | - | + | - | + | | |
| 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 | 0 |
| 12.5 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 | 0 |
| 18.75 | 27 | 3 | 22 | 8 | 24 | 6 | 73 | 17 | 81.1 | 18.9 |
| 22.5 | 15 | 15 | 16 | 14 | 14 | 16 | 45 | 45 | 50.0 | 50.0 |
| 25 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
| 50 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
| 100 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
| 200 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
Cassette Format
| hCG
Concentration
(mIU/mL) | hCG190501 | | hCG190502 | | hCG190503 | | The total of
the results | | Negative
compliance rate
(%) | Positive compliance
Rate
(%) |
|----------------------------------|-----------|----|-----------|----|-----------|----|-----------------------------|----|------------------------------------|------------------------------------|
| | - | + | - | + | - | + | - | + | | |
| 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 | 0 |
| 12.5 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 | 0 |
| 18.75 | 23 | 7 | 26 | 4 | 24 | 6 | 73 | 17 | 81.1 | 18.9 |
| 22.5 | 17 | 13 | 15 | 15 | 14 | 16 | 46 | 44 | 51.1 | 48.9 |
| 25 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
| 50 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
| 100 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
| 200 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
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Image /page/8/Picture/0 description: The image shows the logo for SEJOY. The logo is in blue and has a yellow triangle above the letters. The letters are in a bold, sans-serif font. The registered trademark symbol is to the right of the letter Y.
Midstream Format
| hCG
Concentration
(mIU/mL) | hCG190601 | | hCG190602 | | hCG190603 | | The total of
the results | | Negative
compliance rate
(%) | Positive compliance
Rate
(%) |
|----------------------------------|-----------|----|-----------|----|-----------|----|-----------------------------|----|------------------------------------|------------------------------------|
| | - | + | - | + | - | + | - | + | | |
| 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 | 0 |
| 12.5 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 | 0 |
| 18.75 | 25 | 5 | 24 | 6 | 24 | 6 | 73 | 17 | 81.1 | 18.9 |
| 22.5 | 15 | 15 | 16 | 14 | 15 | 15 | 46 | 44 | 51.1 | 48.9 |
| 25 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
| 50 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
| 100 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
| 200 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
Strip Format:Operator 1&2&3
| hCG
Concentration
(mIU/mL) | | hCG190401 | | hCG190402 | | hCG190403 | | The total of
the results | | Negative
compliance rate
(%) | Positive compliance
Rate
(%) |
|----------------------------------|--|-----------|----|-----------|----|-----------|----|-----------------------------|-----|------------------------------------|------------------------------------|
| | | - | + | - | + | - | + | - | + | | |
| 0 | | 90 | 0 | 90 | 0 | 90 | 0 | 270 | 0 | 100 | 0 |
| 12.5 | | 90 | 0 | 90 | 0 | 90 | 0 | 270 | 0 | 100 | 0 |
| 18.75 | | 74 | 16 | 73 | 17 | 72 | 18 | 219 | 51 | 81.1 | 18.9 |
| 22.5 | | 51 | 39 | 48 | 42 | 40 | 50 | 139 | 131 | 51.5 | 48.5 |
| 25 | | 0 | 90 | 0 | 90 | 0 | 90 | 0 | 270 | 0 | 100 |
| 50 | | 0 | 90 | 0 | 90 | 0 | 90 | 0 | 270 | 0 | 100 |
| 100 | | 0 | 90 | 0 | 90 | 0 | 90 | 0 | 270 | 0 | 100 |
| 200 | | 0 | 90 | 0 | 90 | 0 | 90 | 0 | 270 | 0 | 100 |
Cassette Format:Operator 1&2&3
| hCG
Concentration
(mIU/mL) | hCG190501 | | hCG190502 | | hCG190503 | | The total of
the results | | Negative
compliance rate
(%) | Positive compliance
Rate
(%) |
|----------------------------------|-----------|----|-----------|----|-----------|----|-----------------------------|-----|------------------------------------|------------------------------------|
| | - | + | - | + | - | + | - | + | | |
| 0 | 90 | 0 | 90 | 0 | 90 | 0 | 270 | 0 | 100.0 | 0.0 |
| 12.5 | 90 | 0 | 90 | 0 | 90 | 0 | 270 | 0 | 100.0 | 0.0 |
| 18.75 | 70 | 20 | 75 | 15 | 73 | 17 | 218 | 52 | 80.7 | 19.3 |
| 22.5 | 50 | 40 | 44 | 46 | 44 | 46 | 138 | 132 | 51.1 | 48.9 |
| 25 | 0 | 90 | 0 | 90 | 0 | 90 | 0 | 270 | 0.0 | 100.0 |
| 50 | 0 | 90 | 0 | 90 | 0 | 90 | 0 | 270 | 0.0 | 100.0 |
| 100 | 0 | 90 | 0 | 90 | 0 | 90 | 0 | 270 | 0.0 | 100.0 |
| 200 | 0 | 90 | 0 | 90 | 0 | 90 | 0 | 270 | 0.0 | 100.0 |
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Image /page/9/Picture/0 description: The image shows the word "SEJOY" in blue, with a small orange triangle above the "J". The letters are large and bold, and the word appears to be a logo or brand name. A registered trademark symbol is located to the bottom right of the word.
| hCG
Concentration
(mIU/mL) | hCG190601 | | hCG190602 | | hCG190603 | | The total of
the results | | Negative
compliance rate
(%) | Positive compliance
Rate
(%) |
|----------------------------------|-----------|----|-----------|----|-----------|----|-----------------------------|-----|------------------------------------|------------------------------------|
| | - | + | - | + | - | + | - | + | | |
| 0 | 90 | 0 | 90 | 0 | 90 | 0 | 270 | 0 | 100 | 0 |
| 12.5 | 90 | 0 | 90 | 0 | 90 | 0 | 270 | 0 | 100 | 0 |
| 18.75 | 76 | 14 | 74 | 16 | 72 | 18 | 222 | 48 | 82.2 | 17.8 |
| 22.5 | 46 | 44 | 46 | 44 | 49 | 41 | 141 | 129 | 52.2 | 47.8 |
| 25 | 0 | 90 | 0 | 90 | 0 | 90 | 0 | 270 | 0 | 100 |
| 50 | 0 | 90 | 0 | 90 | 0 | 90 | 0 | 270 | 0 | 100 |
| 100 | 0 | 90 | 0 | 90 | 0 | 90 | 0 | 270 | 0 | 100 |
| 200 | 0 | 90 | 0 | 90 | 0 | 90 | 0 | 270 | 0 | 100 |
Midstream Format:Operator 1&2&3
b. Linearity/assay reportable range:
Linearity is not applicable since this is a qualitative test.
c. Hook effect test:
Negative urine samples were spiked with varying hCG concentrations (25mIU/mL, 100mIU/mL, 1IU/mL,10IU/mL,100IU/mL,150IU/mL,500IU/mL,1000IU/mL,2000IU/mL).All tested concentrations gave a positive result. The results demonstrated that no hook effect up to 2000U/mL.
d. Traceability,Stability,Expected values (controls,calibrators,or methods):
SEJOY hCG One Step Pregnancy Test is calibrated against reference material traceable to WHO International Standard 5th edition.
The stability data supports that the products have the shelf life of 24 months when stored at 2-30 ℃.
e. Cross-reactivity
To evaluate cross-reactivity, 0 mIU/mL negative urine samples, 10 mIU/mL positive urine samples and 25 mIU/mL positive urine samples were spiked with various concentrations of LH, FSH, TSH and hCG ß-core fragment. The results showed that there is no cross reaction at 500mIU/mL LH, 1000mIU/mL FSH,1000mIU/L TSH and 2000,000pmol/L hCG ß-core fragment for both negative and positive samples.
f. Interfering substance
To evaluate the potential for interference by certain exogenous compounds, each interfering substance was prepared by diluting stock interfering material to the desired concentration.Negative urine samples and positive urine samples containing 10 mIU/mL and 25 mIU/mL hCG were spiked with the interfering substance to obtain the desired test concentration.No interferences were observed from exogenous compounds at the following concentrations for both negative and positive hCG urine
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Image /page/10/Picture/0 description: The image shows the logo for SEJOY. The logo is blue and has a yellow triangle above the "J". There is a registered trademark symbol to the right of the "Y".
samples.
| Analyte | Concentration |
|---|---|
| Acetaminophen | 20mg/dL |
| Acetoacetic Acid | 2000mg/dL |
| Ascorbic Acid | 20mg/dL |
| B-hydroxybutyrate | 2000mg/dL |
| Caffeine | 20mg/dL |
| Ephedrine | 20mg/dL |
| Gentisic Acid | 20mg/dL |
| Phenylpropanolamine | 20mg/dL |
| Salicylic Acid | 20mg/dL |
| Phenothiazine | 20mg/dL |
| EDTA | 80mg/dL |
| Acetylsalicylic Acid | 20mg/dL |
| Benzoylecgonine | 10mg/dL |
| Cannabinol | 10mg/dL |
| Codeine | 6ug/dL |
| Ethanol | 1.00% |
| Methanol | 10% |
| Albumin | 2000mg/dL |
| Glucose | 2000mg/dL |
| Bilirubin | 2mg/dL |
| Atropine | 20mg/dL |
| Estriol-17-beta | 1400ug/dL |
| Hemoglobin | 500mg/dL |
| Pregnanediol | 1500ug/dL |
| Thiophene | 20mg/dL |
| Ampicillin | 20mg/dL |
| Tetracycline | 20mg/dL |
| Ketone | 20mg/dL |
g. Effect of urine pH
To evaluate potential interference from changes in pH, negative urine samples and positive urine samples containing 10 mIU/mL and 25 mIU/mL hCG were tested at pH values of 4, 5, 6, 7, 8 and 9. The results indicated that changes in pH range of 4~9 do not interfere in the results that were either positive or negative for hCG.
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Image /page/11/Picture/0 description: The image shows the logo for SEJOY. The logo is blue and has a yellow triangle above the "J". There is a registered trademark symbol to the right of the "Y".
h. Effect of Specific Gravity
Negative specimen containing 0 mIU/mL,12.5 mIU/mL and 25mlU/mL hCG were adjusted to specific gravities of 1.000, 1.012, 1.020, 1.030,1.037.One different lots for each format were tested. The results showed no interference in samples with specific gravity ranging from 1.000-1.037.
B. Method Comparison Study
Method comparison with predicate device
The performance of the proposed device was compared to the predicate test. For strip and cassette format,urine samples were collected from 150 women presenting to test for pregnancy. Approximately half of the 150 women were suspected to be pregnant. For midstream format,urine samples were collected from 135 women presenting to test for pregnancy. Approximately half of the 135 women were suspected to be pregnant.All samples were tested by three different health professionals for each format at the 3 POC sites for a total of 12 POC operators with the proposed and the predicate devices.
Strip format
| Product | Predicate device | ||
|---|---|---|---|
| Negative | Positive | ||
| SEJOY hCG One Step | |||
| Pregnancy Test Strip | Negative | 72 | 0 |
| Positive | 0 | 78 |
Cassette format
| Product | Predicate device | ||
|---|---|---|---|
| Negative | Positive | ||
| SEJOY hCG One Step | |||
| Pregnancy Test Cassette | Negative | 72 | 0 |
| Positive | 0 | 78 |
Midstream format (dip method)
| Product | Predicate device | ||
|---|---|---|---|
| Negative | Positive | ||
| SEJOY hCG One Step | |||
| Pregnancy Test Midstream | Negative | 72 | 0 |
| Positive | 0 | 63 |
Midstream format (simulate stream method)
| Product | Predicate device | ||
|---|---|---|---|
| Negative | Positive | ||
| SEJOY hCG One Step | |||
| Pregnancy Test Midstream | Negative | 72 | 0 |
| Positive | 0 | 63 |
Conclusion from the above table:
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Image /page/12/Picture/0 description: The image shows the logo for SEJOY. The logo is blue and has a yellow triangle above the letters "JO". There is a registered trademark symbol to the right of the letter "Y".
The average positive conformity rate of Rapid Pregnancy Test is 100%. The average negative conformity rate of Rapid Pregnancy Test is 100%.
C. Lay person study:
440 women's individual pregnancy status was self-tested, varying educational and occupational backgrounds 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.
Strip format
| SEJOY hCG One Step Pregnancy Test Strip | Professional | ||
|---|---|---|---|
| Positive | Negative | ||
| Lay person | Positive | 46 | 0 |
| Negative | 0 | 64 |
Cassette format
| SEJOY hCG One Step Pregnancy Test Cassette | Professional | ||
|---|---|---|---|
| Positive | Negative | ||
| Lay person | Positive | 44 | 0 |
| Negative | 0 | 66 |
Midstream format (dip method)
| SEJOY hCG One Step Pregnancy Test Midstream | Professional | ||
|---|---|---|---|
| Positive | Negative | ||
| Lay person | Positive | 42 | 0 |
| Negative | 0 | 68 |
Midstream format (simulate stream method)
| SEJOY hCG One Step Pregnancy Test Midstream | Professional | ||
|---|---|---|---|
| Positive | Negative | ||
| Lay person | Positive | 45 | 0 |
| Negative | 0 | 65 |
From the above tables, the lay person results showed 100% positive and 100% negative conformity with the professional results.
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.
10. Conclusion
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Image /page/13/Picture/0 description: The image shows the word "SEJOY" in blue font. There is a small yellow triangle above the "J" in the word. The font is bold and sans-serif. There is a registered trademark symbol to the right of the "Y".
The SEJOY hCG One Step Pregnancy Test is substantially equivalent to the legally marketed predicative device CLUNGENE HCG Pregnancy Rapid Test (K193132)