SEJOY hCG One Step Pregnancy Test Strip, SEJOY hCG One Step Pregnancy Test Cassette, SEJOY hCG One Step Pregnancy Test Midstream

K212447 · Hangzhou Sejoy Electronics & Instruments Co., Ltd. · LCX · Feb 18, 2022 · Clinical Chemistry

Device Facts

• Record ID: K212447
• Device Name: SEJOY hCG One Step Pregnancy Test Strip, SEJOY hCG One Step Pregnancy Test Cassette, SEJOY hCG One Step Pregnancy Test Midstream
• Applicant: Hangzhou Sejoy Electronics & Instruments Co., Ltd.
• Product Code: LCX · Clinical Chemistry
• Decision Date: Feb 18, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

The SEJOY hCG One Step Pregnancy Test Strip is a rapid, one-step lateral flow immunoassay for the qualitative detection of human chorionic glycoprotein (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.

Device Story

Rapid, one-step lateral flow sandwich immunoassay for qualitative hCG detection in urine; aids early pregnancy detection. Formats: strip, cassette, midstream. Principle: monoclonal antibodies directed against alpha and beta hCG subunits; hCG in sample binds to form colored line at test zone ('T'); control zone ('C') confirms proper performance. User-operated (OTC): dip strip, add urine to cassette well, or urinate on/dip midstream absorbent tip. Visual result read at 3-5 minutes. Two lines (T and C) indicate positive; one line (C only) indicates negative; no C line indicates invalid. Benefits: provides rapid, accessible pregnancy screening for lay users.

Clinical Evidence

Bench testing included precision/reproducibility studies (n=270 per concentration/format), interference testing (exogenous/endogenous substances, pH, specific gravity, hook effect, beta-core fragment), and method comparison against predicate (n=150). Lay user study (n=440) demonstrated 100% agreement between lay user and professional results. No clinical sensitivity/specificity studies required for this qualitative immunoassay.

Technological Characteristics

Lateral flow sandwich immunoassay; monoclonal antibodies against alpha/beta hCG subunits. Cut-off: 25 mIU/mL. Formats: strip, cassette, midstream. Traceable to WHO 5th International Standard (NIBSC 07/364). No electronic components, software, or energy sources. Interference testing per CLSI EP07.

Indications for Use

Indicated for qualitative detection of hCG in urine to aid in early pregnancy detection. Intended for over-the-counter (OTC) use by lay users.

Regulatory Classification

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. 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.

Predicate Devices

• CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test Strip, CLUNGENE HCG Pregnancy Rapid Test Midstream (K193132)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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.

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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 ([e-mail]) or phone [phone] 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

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# 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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Image /page/3/Picture/0 description: The image shows the logo for SEJOY. The logo is in blue, with a yellow triangle above the "J". There is a registered trademark symbol to the bottom right of the logo.

# 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. | [phone] |
| Fax. | [phone] |
| 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<br>SEJOY hCG One Step Pregnancy Test Cassette<br>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,<br>CLUNGENE HCG Pregnancy Rapid Test Strip,<br>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:<br>SEJOY HCG One Step<br>Pregnancy Test | Predicate Device:<br>(K193132) |
|-------------------------------------|----------------------------------------------------------|-----------------------------------|
| Regulation number | 862.1155 | 862.1155 |
| Classification | 2 | 2 |
| Product Code | LCX | LCX |
| Intended use/Indications<br>for use | Aid in the detection of pregnancy | Aid in the detection of pregnancy |
| Methodology | Immunochromatographic<br>assay | Immunochromatographic<br>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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Image /page/5/Picture/1 description: The image shows the word "SEJOY" in large, blue, sans-serif font. Above the "J" is a small, yellow triangle pointing downwards. A small "R" in a circle is located to the bottom right of the "Y".

## 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<br>Concentration<br>(mIU/mL) | hCG190401 | | hCG190402 | | hCG190403 | | The total of<br>the results | | Negative<br>compliance rate<br>(%) | Positive<br>compliance Rate<br>(%) |
|----------------------------------|-----------|----|-----------|----|-----------|----|-----------------------------|----|------------------------------------|------------------------------------|
| | - | + | - | + | - | + | - | + | | |
| 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<br>Concentration<br>(mIU/mL) | hCG190501 | | hCG190502 | | hCG190503 | | The total of<br>the results | | Negative<br>compliance rate<br>(%) | Positive compliance<br>Rate<br>(%) |
|----------------------------------|-----------|----|-----------|----|-----------|----|-----------------------------|----|------------------------------------|------------------------------------|
| | - | + | - | + | - | + | - | + | | |
| 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<br>Concentration | hCG190601 | hCG190602 | hCG190603 | The total of<br>the results | Negative<br>compliance rate | Positive compliance<br>Rate |
|----------------------|-----------|-----------|-----------|-----------------------------|-----------------------------|-----------------------------|
|----------------------|-----------|-----------|-----------|-----------------------------|-----------------------------|-----------------------------|

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Image /page/6/Picture/0 description: The image shows the logo for SEJOY. The logo is blue, with a yellow triangle above the "J". There is a registered trademark symbol to the right of the "Y".

| (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<br>Concentration<br>(mIU/mL) | hCG190401 | | hCG190402 | | hCG190403 | | The total of<br>the results | | Negative<br>compliance rate<br>(%) | Positive compliance<br>Rate<br>(%) |
|----------------------------------|-----------|----|-----------|----|-----------|----|-----------------------------|----|------------------------------------|------------------------------------|
| | - | + | - | + | - | + | - | + | | |
| 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<br>Concentration<br>(mIU/mL) | hCG190501 | | hCG190502 | | hCG190503 | | The total of<br>the results | | Negative<br>compliance rate<br>(%) | Positive compliance<br>Rate<br>(%) |
|----------------------------------|-----------|----|-----------|----|-----------|----|-----------------------------|----|------------------------------------|------------------------------------|
| | - | + | - | + | - | + | - | + | | |
| 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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Image /page/7/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<br>Concentration | hCG190601 | | hCG190602 | | hCG190603 | | The total of<br>the results | | Negative<br>compliance rate | Positive compliance<br>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<br>Concentration<br>(mIU/mL) | hCG190401 | | hCG190402 | | hCG190403 | | The total of<br>the results | | Negative<br>compliance rate<br>(%) | Positive compliance<br>Rate<br>(%) |
|----------------------------------|-----------|----|-----------|----|-----------|----|-----------------------------|----|------------------------------------|------------------------------------|
| | - | + | - | + | - | + | - | + | | |
| 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<br>Concentration<br>(mIU/mL) | hCG190501 | | hCG190502 | | hCG190503 | | The total of<br>the results | | Negative<br>compliance rate<br>(%) | Positive compliance<br>Rate<br>(%) |
|----------------------------------|-----------|----|-----------|----|-----------|----|-----------------------------|----|------------------------------------|------------------------------------|
| | - | + | - | + | - | + | - | + | | |
| 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<br>Concentration<br>(mIU/mL) | hCG190601 | | hCG190602 | | hCG190603 | | The total of<br>the results | | Negative<br>compliance rate<br>(%) | Positive compliance<br>Rate<br>(%) |
|----------------------------------|-----------|----|-----------|----|-----------|----|-----------------------------|----|------------------------------------|------------------------------------|
| | - | + | - | + | - | + | - | + | | |
| 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<br>Concentration<br>(mIU/mL) | | hCG190401 | | hCG190402 | | hCG190403 | | The total of<br>the results | | Negative<br>compliance rate<br>(%) | Positive compliance<br>Rate<br>(%) |
|----------------------------------|--|-----------|----|-----------|----|-----------|----|-----------------------------|-----|------------------------------------|------------------------------------|
| | | - | + | - | + | - | + | - | + | | |
| 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<br>Concentration<br>(mIU/mL) | hCG190501 | | hCG190502 | | hCG190503 | | The total of<br>the results | | Negative<br>compliance rate<br>(%) | Positive compliance<br>Rate<br>(%) |
|----------------------------------|-----------|----|-----------|----|-----------|----|-----------------------------|-----|------------------------------------|------------------------------------|
| | - | + | - | + | - | + | - | + | | |
| 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<br>Concentration<br>(mIU/mL) | hCG190601 | | hCG190602 | | hCG190603 | | The total of<br>the results | | Negative<br>compliance rate<br>(%) | Positive compliance<br>Rate<br>(%) |
|----------------------------------|-----------|----|-----------|----|-----------|----|-----------------------------|-----|------------------------------------|------------------------------------|
| | - | + | - | + | - | + | - | + | | |
| 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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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<br>Pregnancy Test Strip | Negative | 72 | 0 |
| | Positive | 0 | 78 |

Cassette format

| Product | Predicate device | | |
|-----------------------------------------------|------------------|----------|----|
| | Negative | Positive | |
| SEJOY hCG One Step<br>Pregnancy Test Cassette | Negative | 72 | 0 |
| | Positive | 0 | 78 |

#### Midstream format (dip method)

| Product | Predicate device | | |
|------------------------------------------------|------------------|----------|----|
| | Negative | Positive | |
| SEJOY hCG One Step<br>Pregnancy Test Midstream | Negative | 72 | 0 |
| | Positive | 0 | 63 |

#### Midstream format (simulate stream method)

| Product | Predicate device | | |
|------------------------------------------------|------------------|----------|----|
| | Negative | Positive | |
| SEJOY hCG One Step<br>Pregnancy Test Midstream | Negative | 72 | 0 |
| | Positive | 0 | 63 |

Conclusion from the above table:

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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)