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.

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.

AI/ML Overview

The provided document is a 510(k) summary for the SEJOY hCG One Step Pregnancy Test, a medical device for qualitative detection of hCG in urine. It details the device's performance characteristics, including analytical performance and method comparison studies.

Here's an analysis of the acceptance criteria and the studies that prove the device meets these criteria, as presented in the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" as a single, consolidated table with specific positive/negative compliance rate targets for a combined "test set" in the way a rigorous AI/ML performance study might. Instead, it presents performance data from multiple analytical and comparative studies. However, for a qualitative test like this, the implicit acceptance criteria are generally 100% agreement for negative and sufficiently high agreement (often 95% or higher) for positive cases, especially at and above the claimed sensitivity. The performance tables demonstrate this.

Here’s a summary of the relevant performance data, interpreted as meeting implicit acceptance criteria:

Device Performance Summary (Based on provided data):

Test	Acceptance Criteria (Implicit)	Reported Device Performance
Analytical Sensitivity (Individual Operator Data)
0 mIU/mL hCG	100% Negative Compliance	100% Negative Compliance across all operators, lots, and formats
12.5 mIU/mL hCG	100% Negative Compliance	100% Negative Compliance across all operators, lots, and formats
25 mIU/mL hCG and above (50, 100, 200 mIU/mL)	100% Positive Compliance	100% Positive Compliance across all operators, lots, and formats
18.75 mIU/mL hCG (Gray Zone)	Expected to show mixed compliance / some false negatives. No explicit strict acceptance criteria given at this sub-sensitivity level, but the data indicates the expected behavior around the analytical sensitivity.	Range of positive compliance (e.g., Operator 1, Strip: 17.8%, Cassette: 18.9%, Midstream: 15.6%). See detailed tables below for specific values.
22.5 mIU/mL hCG (Gray Zone)	Expected to show mixed compliance / some false negatives, nearing 50/50. No explicit strict acceptance criteria given at this sub-sensitivity level, but the data indicates the expected behavior around the analytical sensitivity.	Range of positive compliance (e.g., Operator 1, Strip: 47.8%, Cassette: 48.9%, Midstream: 46.7%). See detailed tables below for specific values.
Analytical Sensitivity (Combined Operator Data)
0 mIU/mL hCG	100% Negative Compliance	100% Negative Compliance across all lots and formats (N=270 for each).
12.5 mIU/mL hCG	100% Negative Compliance	100% Negative Compliance across all lots and formats (N=270 for each).
25 mIU/mL hCG and above (50, 100, 200 mIU/mL)	100% Positive Compliance	100% Positive Compliance across all lots and formats (N=270 for each).
18.75 mIU/mL hCG (Combined Operators)	Expected to show mixed results, as it's below the 25 mIU/mL cutoff.	Strip: 18.9% Positive, Cassette: 19.3% Positive, Midstream: 17.8% Positive.
22.5 mIU/mL hCG (Combined Operators)	Expected to show mixed results, as it's below the 25 mIU/mL cutoff.	Strip: 48.5% Positive, Cassette: 48.9% Positive, Midstream: 47.8% Positive.
Method Comparison Study	100% Agreement with predicate device (implicit)	100% Positive Conformity, 100% Negative Conformity for all formats
Lay Person Study	100% Agreement with Professional Results (implicit)	100% Positive Conformity, 100% Negative Conformity for all formats

Detailed Performance Tables from the text (Acceptance Criteria met where "100%"):

Analytical Performance (Precision/Reproducibility/Sensitivity) - Combined Operator Data:

Strip Format: Operator 1&2&3

hCG Conc. (mIU/mL)	Negative Compliance Rate (%)	Positive Compliance Rate (%)
0	100	0
12.5	100	0
18.75	81.1	18.9
22.5	51.5	48.5
25	0	100
50	0	100
100	0	100
200	0	100

Cassette Format: Operator 1&2&3

hCG Conc. (mIU/mL)	Negative Compliance Rate (%)	Positive Compliance Rate (%)
0	100.0	0.0
12.5	100.0	0.0
18.75	80.7	19.3
22.5	51.1	48.9
25	0.0	100.0
50	0.0	100.0
100	0.0	100.0
200	0.0	100.0

Midstream Format: Operator 1&2&3

hCG Conc. (mIU/mL)	Negative Compliance Rate (%)	Positive Compliance Rate (%)
0	100	0
12.5	100	0
18.75	82.2	17.8
22.5	52.2	47.8
25	0	100
50	0	100
100	0	100
200	0	100

Method Comparison Study (N agreement with predicate device):

Strip Format: Positive: 78/78 (100%), Negative: 72/72 (100%)
Cassette Format: Positive: 78/78 (100%), Negative: 72/72 (100%)
Midstream Format (dip): Positive: 63/63 (100%), Negative: 72/72 (100%)
Midstream Format (simulate stream): Positive: 63/63 (100%), Negative: 72/72 (100%)

Lay Person Study (N agreement with professional results):

Strip Format: Positive: 46/46 (100%), Negative: 64/64 (100%)
Cassette Format: Positive: 44/44 (100%), Negative: 66/66 (100%)
Midstream Format (dip): Positive: 42/42 (100%), Negative: 68/68 (100%)
Midstream Format (simulate stream): Positive: 45/45 (100%), Negative: 65/65 (100%)

2. Sample Size Used for the Test Set and Data Provenance:

Analytical Performance (Precision/Reproducibility/Sensitivity):
- Sample Size: For each format (Strip, Cassette, Midstream), and for each hCG concentration (0, 12.5, 18.75, 22.5, 25, 50, 100, 200 mIU/mL), 3 different lots were tested. For each lot and concentration, 3 operators performed tests, with 2 runs per day for 15 days. This means for each operator, lot, and concentration, 30 replicates were performed (2 runs/day * 15 days = 30).
- Total replicates per hCG concentration per format: 3 lots * 30 replicates/lot/operator * 3 operators = 270 replicates.
- Total replicates across all concentrations for one format: 8 concentrations * 270 replicates = 2160 replicates.
- Data Provenance: Not explicitly stated, but given the company is based in China (Hangzhou), the testing was likely conducted in China. The study is prospective as it involves controlled spiking of urine samples and systematic testing.
Method Comparison Study (Clinical Performance in real samples):
- Sample Size:
  - Strip and Cassette formats: Urine samples from 150 women. Approximately half (around 75) were suspected to be pregnant.
  - Midstream format: Urine samples from 135 women. Approximately half (around 67 or 68) were suspected to be pregnant.
- Data Provenance: Not explicitly stated for the source of these patient samples. Implied to be clinical samples from patients presenting for pregnancy testing. The study design (comparing device to a predicate at POC sites) suggests a prospective clinical study.
Lay Person Study:
- Sample Size: 440 women.
- Data Provenance: Not explicitly stated, but it describes "women's individual pregnancy status was self-tested, varying educational and occupational backgrounds were chosen for the study." This implies a prospective study involving real users.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:

Analytical Performance: The ground truth for spiked samples (0, 12.5, 18.75, 22.5, 25, 50, 100, 200 mIU/mL) is intrinsically defined by the known hCG concentrations. The hCG standard is "Traceable to the 5th WHO," indicating a robust and internationally recognized standard. The device's reading sensitivity is 25 mIU/mL. Human "experts" are not needed to establish this ground truth, as it's a precisely formulated laboratory experiment.
Method Comparison Study: The ground truth for the clinical samples was established by the predicate device (CLUNGENE HCG Pregnancy Rapid Test, K193132). The study aimed to show conformity with this established method. "Three different health professionals for each format at the 3 POC sites for a total of 12 POC operators" were involved in testing the samples with both the proposed and predicate devices. Their qualifications (e.g., specific medical titles, years of experience) are not detailed, but they are referred to as "health professionals."
Lay Person Study: The ground truth for the lay person study was "professional testing." This professional testing served as the reference standard against which the lay person's self-test results were compared. The specific qualifications of these "professionals" are not detailed.

4. Adjudication Method for the Test Set:

Analytical Performance: No adjudication method as the ground truth is based on precise spiked concentrations. Results are reported directly based on optical interpretation of the test strips.
Method Comparison Study: Not explicitly stated. However, given that multiple "health professionals" at "3 POC sites" tested the samples, it is implied that the results were compared directly between the proposed device and the predicate device. If there were discrepancies, the document does not describe a formal adjudication process (e.g., by a third, blinded reader). The results simply state 100% conformity, suggesting no discrepancies or that any discrepancies were resolved in a non-specified manner.
Lay Person Study: Not explicitly stated. The lay person's self-test results were compared to "professional testing." It's implied that discrepancies (if any) would highlight issues with lay user interpretation. The reported 100% conformity suggests no discrepancies between lay user and professional results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs. without AI assistance:

This device is a simple, qualitative immunoassay (lateral flow test), not an AI/ML-driven diagnostic tool. Therefore, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study focusing on human reader improvement with AI assistance is not applicable to this device. The studies were designed to confirm the device's accuracy against known concentrations, a predicate device, and lay user interpretation.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This is not a software-based AI algorithm. The device is a physical test strip/cassette/midstream that provides a visual reading (presence or absence of control and test lines). Its "performance" is inherently tied to the chemical reaction and the visual interpretation, whether by an operator (analytical/method comparison studies) or a lay person (lay person study). There is no "algorithm only" component that would perform independently of human interaction or a physical sample.

7. The Type of Ground Truth Used:

Analytical Performance: Known, precisely titrated hCG concentrations (traceable to WHO International Standard 5th edition). This is a strong, objective ground truth for analytical sensitivity.
Method Comparison Study: Predicate device results (CLUNGENE HCG Pregnancy Rapid Test, K193132). This is a comparative "gold standard" for regulatory purposes, showing equivalence to an already approved device.
Lay Person Study: Professional testing results. This acts as the "gold standard" for the interpretation study, ensuring that device performance under lay use conditions is objectively assessed against trained personnel.

8. The Sample Size for the Training Set:

This document describes a K-number premarket notification for a medical device (hCG pregnancy test) that is based on a chemical immunoassay, not an AI/Machine Learning algorithm. Therefore, there is no concept of a "training set" as would be relevant for an AI/ML model. The studies described are for validation and performance testing of the physical device.

9. How the Ground Truth for the Training Set was Established:

As there is no training set for this type of device (non-AI/ML), this question is not applicable. The ground truth for the test and validation studies (as described in point 7) was established through known concentrations, predicate device results, and professional testing.

Summary

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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.

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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 (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

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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)

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 StripSEJOY hCG One Step Pregnancy Test CassetteSEJOY 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

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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 StepPregnancy Test	Predicate Device:(K193132)
Regulation number	862.1155	862.1155
Classification	2	2
Product Code	LCX	LCX
Intended use/Indicationsfor use	Aid in the detection of pregnancy	Aid in the detection of pregnancy
Methodology	Immunochromatographicassay	Immunochromatographicassay
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:

hCGConcentration(mIU/mL)	hCG190401		hCG190402		hCG190403		The total ofthe results		Negativecompliance rate(%)	Positivecompliance 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

hCGConcentration(mIU/mL)	hCG190501		hCG190502		hCG190503		The total ofthe results		Negativecompliance rate(%)	Positive complianceRate(%)
	-	+	-	+	-	+	-	+
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

hCGConcentration	hCG190601	hCG190602	hCG190603	The total ofthe results	Negativecompliance rate	Positive complianceRate
----------------------	-----------	-----------	-----------	-----------------------------	-----------------------------	-----------------------------

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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

hCGConcentration(mIU/mL)	hCG190401		hCG190402		hCG190403		The total ofthe results		Negativecompliance rate(%)	Positive complianceRate(%)
	-	+	-	+	-	+	-	+
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

hCGConcentration(mIU/mL)	hCG190501		hCG190502		hCG190503		The total ofthe results		Negativecompliance rate(%)	Positive complianceRate(%)
	-	+	-	+	-	+	-	+
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

hCGConcentration	hCG190601		hCG190602		hCG190603		The total ofthe results		Negativecompliance rate	Positive complianceRate
(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

hCGConcentration(mIU/mL)	hCG190401		hCG190402		hCG190403		The total ofthe results		Negativecompliance rate(%)	Positive complianceRate(%)
	-	+	-	+	-	+	-	+
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

hCGConcentration(mIU/mL)	hCG190501		hCG190502		hCG190503		The total ofthe results		Negativecompliance rate(%)	Positive complianceRate(%)
	-	+	-	+	-	+	-	+
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

hCGConcentration(mIU/mL)	hCG190601		hCG190602		hCG190603		The total ofthe results		Negativecompliance rate(%)	Positive complianceRate(%)
	-	+	-	+	-	+	-	+
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

hCGConcentration(mIU/mL)	hCG190401		hCG190402		hCG190403		The total ofthe results		Negativecompliance rate(%)	Positive complianceRate(%)
	-	+	-	+	-	+	-	+
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

hCGConcentration(mIU/mL)	hCG190501		hCG190502		hCG190503		The total ofthe results		Negativecompliance rate(%)	Positive complianceRate(%)
	-	+	-	+	-	+	-	+
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.

hCGConcentration(mIU/mL)	hCG190601		hCG190602		hCG190603		The total ofthe results		Negativecompliance rate(%)	Positive complianceRate(%)
	-	+	-	+	-	+	-	+
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 StepPregnancy Test Strip	Negative	72	0
	Positive	0	78

Cassette format

Product	Predicate device
	Negative	Positive
SEJOY hCG One StepPregnancy Test Cassette	Negative	72	0
	Positive	0	78

Midstream format (dip method)

Product	Predicate device
	Negative	Positive
SEJOY hCG One StepPregnancy Test Midstream	Negative	72	0
	Positive	0	63

Midstream format (simulate stream method)

Product	Predicate device
	Negative	Positive
SEJOY hCG One StepPregnancy 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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The SEJOY hCG One Step Pregnancy Test is substantially equivalent to the legally marketed predicative device CLUNGENE HCG Pregnancy Rapid Test (K193132)

Regulation Number and Section

§ 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.