Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies indicate a traditional lateral flow immunoassay for detecting hCG, with no mention of AI or ML for result interpretation or any other function.

Therapeutic

No
The device is an in vitro diagnostic device used for early detection of pregnancy, not for treating any condition or disease.

Diagnostic

Yes

The device detects Human Chorionic Gonadotropin (HCG) in human urine as an "aid in early detection of pregnancy," which is a diagnostic purpose. The text also states that "All results should be confirmed by your healthcare provider, especially when making decisions about future medical care," further indicating its role in providing information for medical decisions.

SaMD (Software as a Medical Device)

No

The device description clearly states that the device is a physical test strip, cassette, or midstream format that utilizes antibodies to detect hCG in urine and displays results visually. This is a hardware-based diagnostic test, not a software-only device.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use explicitly states that the device is used for the "qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine." This is a diagnostic test performed on a biological sample (urine) to aid in the detection of a medical condition (pregnancy).
Sample Type: The device analyzes human urine, which is a biological specimen.
Purpose: The purpose is to provide information about a person's health status (whether they are pregnant).
Location of Use: While intended for home use, it is still a diagnostic test performed outside the body ("Only for use outside the body").

The definition of an In Vitro Diagnostic device generally includes devices intended for use in the collection, preparation, and examination of specimens taken from the human body for the purpose of providing information for the diagnosis, monitoring, or treatment of a disease or condition. This pregnancy test fits this definition.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

MissLan® Early Detection Pregnancy Test Strip is used for qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine. This test is intended for use as an aid in early detection of pregnancy, in some cases as early as six (6) days before the day of the missed period, (i.e. as early as five (5) days before the day of the expected period). It is intended for use by people who would like to find out whether they are pregnant in a home environment. Only for use outside the body. For over-the-counter use.

Important note regarding positive results:

Because this test detects low levels of hCG, it is possible that this test may give positive results even if you are not pregnant. All results should be confirmed by your healthcare provider, especially when making decisions about future medical care.

This device is intended for home-use only.

MissLan® Early Detection Pregnancy Test Cassette is used for qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine. This test is intended for use as an aid in early detection of pregnancy, in some cases as early as six (6) days before the day of the missed period. (i.e. as early as five (5) days before the day of the expected period). It is intended for use by people who would like to find out whether they are pregnant in a home environment. Only for use outside the body. For over-the-counter use.

Important note regarding positive results:

Because this test detects low levels of hCG, it is possible that this test may give positive results even if you are not pregnant. All results should be confirmed by your healthcare provider, especially when making decisions about future medical care.

This device is intended for home-use only.

MissLan® Early Detection Pregnancy Test Midstream is used for qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine. This test is intended for use as an aid in early detection of pregnancy, in some cases as early as six (6) days before the day of the missed period, (i.e. as early as five (5) days before the day of the expected period). It is intended for use by people who would like to find out whether they are pregnant in a home environment. Only for use outside the body. For over-the-counter use.

Important note regarding positive results:

Because this test detects low levels of hCG, it is possible that this test may give positive results even if you are not pregnant. All results should be confirmed by your healthcare provider, especially when making decisions about future medical care.

This device is intended for home-use only.

Product codes (comma separated list FDA assigned to the subject device)

LCX

Device Description

MissLan® Early Detection Pregnancy Test will be sold in Strip. Cassette and Midstream format. The Strip format is a single test strip. The Cassette format consists of a single test strip assembled in a plastic housing. The Midstream format consists of a single test strip assembled in a plastic housing with an absorbent tip, and is designed to be tested in dip or midstream mode.

MissLan® Early Detection Pregnancy Test Strip. MissLan® Early Detection Pregnancy Test Cassette and MissLan® Early Detection Pregnancy Test Midstream each contains a pouch with the device and instructions, and in addition, cassette format is packaged with pipette dropper and urine collection cup.

The devices utilize a combination of antibodies to detect hCG in urine as well as to serve as a run control. Each device contains mouse monoclonal anti-ß-hCG antibody colloidal gold conjugate pre-dried on the sample pad. Mouse monoclonal anti-a-hCG antibody (on the Test Line) and goat anti mouse IgG polyclonal antibody (on the Control Line) are coated and immobilized on a nitrocellulose membrane. The result is displayed to the user in the test window as two lines for a 'Pregnant' positive result and one line for a 'Not Pregnant' negative result.

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

people who would like to find out whether they are pregnant in a home environment.
home-use only.
For 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

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

a. Precision/Reproducibility/Sensitivity:

Study Type: Analytical Performance - Precision/Reproducibility/Sensitivity
Sample Size: 10 replicates per day for 5 days for each device lot. Total of three device lots for each format were tested, with each operator testing one lot separately. 150 total tests per hCG concentration.
Key Results: Sensitivity of MissLan® Early Detection Pregnancy Test is demonstrated to be 10 mIU/mL.

b. Linearity/assay reportable range:

Study Type: Analytical Performance - Hook effect test
Sample Size: Not explicitly stated, implied by varying hCG concentrations tested.
Key Results: No hook effect was observed at hCG concentration up to 500,000 mIU/mL.

c. Analytical specificity:

Study Type: Interfering substance study
Sample Size: Not explicitly stated.
Key Results: No interference effect was observed at the tested concentrations of various substances.
Study Type: Cross-reactivity study
Sample Size: Not explicitly stated.
Key Results: No cross-reactivity was observed at tested concentration (500 mIU/mL hLH, 1000 mIU/mL hFSH, 1000 µIU/mL hTSH).
Study Type: Effects of hCG ß-core fragment study
Sample Size: Not explicitly stated.
Key Results: The performance of MissLan® Early Detection Pregnancy Test was not affected by hCG ß-core fragment concentrations up to 500,000 pmol/L.
Study Type: Effects of urine pH study
Sample Size: Not explicitly stated.
Key Results: Urine pH ranges between 4 and 9 does not affect the performance of MissLan® Early Detection Pregnancy Test.
Study Type: Effects of urine density study
Sample Size: Not explicitly stated.
Key Results: Urine with a relative density range of 1.000 to 1.035 does not affect the performance of MissLan® Early Detection Pregnancy Test.

d. Method comparison study:

Study Type: Method comparison with predicate device
Sample Size: 400 urine samples (100 for strip, 100 for cassette, 100 for midstream dip, 100 for midstream in-stream).
Data Source: Urine samples collected from 400 women aged 18 to 51 at three clinical sites.
Annotation Protocol: Samples were randomly collected at various times throughout the day, blinded, and randomized. Tested by three professionals using the candidate device and one professional using the predicate device at each site.
Key Results: The conformity between MissLan® Early Detection Pregnancy Test (strip / cassette / midstream) and the predicate device is 100%.

e. Clinical studies:

Study Type: Lay person study (First study)
Sample Size: 400 females (100 for strip, 100 for cassette, 100 for midstream dip, 100 for midstream in-stream).
Data Source: Females with diverse educational and occupational backgrounds and ages ranging from 18 to 51 years old at three sites.
Annotation Protocol: Each subject tested her own urine sample using the device according to the instructions for use, and provided a sample for professional testing.
Key Results: The lay person results showed 100% positive and 100% negative conformity with the professional results.
Study Type: Lay person study (Second study)
Sample Size: 300 laypersons (100 each for strip, cassette, and midstream). Each layperson tested 4 blind-labeled samples.
Data Source: Negative urine sample pools spiked with hCG.
Annotation Protocol: Aliquots were blind labeled. An aliquot of each spiked urine sample was also tested by a professional.
Key Results: The results show that MissLan® Early Detection Pregnancy Test can be used by laypersons to get correct results. Percent Agreement with professional results ranged from 95% to 100%.
Study Type: Early pregnancy detection study
Sample Size: 650 early pregnancy urine samples from 65 pregnant women.
Data Source: Pregnant women.
Annotation Protocol: Each sample was tested with each format of the MissLan® Early Detection Pregnancy Test. For midstream, both dip and in-stream methods were evaluated.
Key Results: The detection rate of MissLan® Early Detection Pregnancy Test in EMP-5 (5 days before expected menstrual period) was 76.92%, in EMP-4 was 96.92%, and in EMP-1 was 100%.
Study Type: Specificity Study to Determine False-Positive Results Rate
Sample Size: 900 urine samples (300 from each of 3 age groups). For each age group, 100 participants for strip, 100 for cassette, 50 for midstream dip, 50 for midstream in-stream.
Data Source: Non-pregnant females in pre-menopausal (18-40 years old), peri-menopausal (41-55 years old), and post-menopausal (>55 years old) age groups at three sites.
Annotation Protocol: Three batches of each format were used.
Key Results: No false positive results were observed for all age groups.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Analytical Sensitivity: 10 mIU/mL
Method Comparison Conformity: 100%
Lay Person Study Conformity (First study): 100% positive, 100% negative.
Lay Person Study Agreement (Second study): 95% to 100% agreement.
Early Pregnancy Detection Rate: EMP-5: 76.92%, EMP-4: 96.92%, EMP-1: 100%.
False-Positive Results Rate (Specificity Study): 0% (No false positive results observed).

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.

K150022

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

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.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

June 21, 2024 Guangzhou Decheng Biotechnology Co., Ltd. % Joe Shia Regulatory Consultant LSI International Inc. 504 East Diamond Ave., Suite H Gaithersburg, Maryland 20877

Re: K240643

Trade/Device Name: MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test Cassette; MissLan® Early Detection 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: May 20, 2024 Received: May 20, 2024

Dear Joe Shia:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

1

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the

Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Paula V. Caposino -S

Paula Caposino, Ph.D. Deputy Division Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K240643

Device Name

MissLan® Early Detection Pregnancy Test Strip MissLan® Early Detection Pregnancy Test Cassette MissLan® Early Detection Pregnancy Test Midstream

Indications for Use (Describe)

MissLan® Early Detection Pregnancy Test Strip is used for qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine. This test is intended for use as an aid in early detection of pregnancy, in some cases as early as six (6) days before the day of the missed period, (i.e. as early as five (5) days before the day of the expected period). It is intended for use by people who would like to find out whether they are pregnant in a home environment. Only for use outside the body. For over-the-counter use.

Important note regarding positive results:

Because this test detects low levels of hCG, it is possible that this test may give positive results even if you are not pregnant. All results should be confirmed by your healthcare provider, especially when making decisions about future medical care.

This device is intended for home-use only.

MissLan® Early Detection Pregnancy Test Cassette is used for qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine. This test is intended for use as an aid in early detection of pregnancy, in some cases as early as six (6) days before the day of the missed period, (i.e. as early as five (5) days before the day of the expected period). It is intended for use by people who would like to find out whether they are pregnant in a home environment. Only for use outside the body. For over-the-counter use.

Important note regarding positive results:

Because this test detects low levels of hCG, it is possible that this test may give positive results even if you are not pregnant. All results should be confirmed by your healthcare provider, especially when making decisions about future medical care.

This device is intended for home-use only.

MissLan® Early Detection Pregnancy Test Midstream is used for qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine. This test is intended for use as an aid in early detection of pregnancy, in some cases as early as six (6) days before the day of the missed period, (i.e. as early as five (5) days before the day of the expected period). It is intended for use by people who would like to find out whether they are pregnant in a home environment. Only for use outside the body. For over-the-counter use.

Important note regarding positive results:

Because this test detects low levels of hCG, it is possible that this test may give positive results even if you are not pregnant. All results should be confirmed by your healthcare provider, especially when making decisions about future medical care.

This device is intended for home-use only.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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510(k) SUMMARY

K240643

1.	Date:	June 21, 2024
2.	Submitter:	Guangzhou Decheng Biotechnology Co., Ltd.
Floor 3/4/5/7, Building A1, No.12, Nanyun 1st
Road, Science City, Huangpu District,
Guangzhou, Guangdong, 510663, P.R. China
3.	Contact person:	Joe Shia
LSI International Inc.
504 East Diamond Ave., Suite H
Gaithersburg, MD 20877
Telephone: 240-505-7880
Email: shiajl@yahoo.com
4.	Device Name:	MissLan® Early Detection Pregnancy Test Strip
MissLan® Early Detection Pregnancy Test Cassette
MissLan® Early Detection Pregnancy Test Midstream
	Classification:
Product Code:
CFR:	Class II
LCX
862.1155
5.	Predicate Devices:	Wondfo One Step HCG Urine Pregnancy Test Midstream,
Wondfo One Step HCG Urine Pregnancy Test Strip,
Wondfo One Step HCG Urine Pregnancy Test Cassette
(K150022)

6. Intended Use

MissLan® Early Detection Pregnancy Test Strip is used for qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine. This test is intended for use as an aid in early detection of pregnancy, in some cases as early as six (6) days before the day of the missed period, (i.e. as early as five (5) days before the day of the expected period). It is intended for use by people who would like to find out whether they are pregnant in a home environment. Only for use outside the body. For over-the-counter use.

Important note regarding positive results:

Because this test detects low levels of hCG, it is possible that this test may give positive results even if you are not pregnant. All results should be confirmed by your healthcare provider, especially when making decisions about future medical care.

5

This device is intended for home-use only.

MissLan® Early Detection Pregnancy Test Cassette is used for qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine. This test is intended for use as an aid in early detection of pregnancy, in some cases as early as six (6) days before the day of the missed period. (i.e. as early as five (5) days before the day of the expected period). It is intended for use by people who would like to find out whether they are pregnant in a home environment. Only for use outside the body. For over-the-counter use.

Important note regarding positive results:

Because this test detects low levels of hCG, it is possible that this test may give positive results even if you are not pregnant. All results should be confirmed by your healthcare provider, especially when making decisions about future medical care.

This device is intended for home-use only.

MissLan® Early Detection Pregnancy Test Midstream is used for qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine. This test is intended for use as an aid in early detection of pregnancy, in some cases as early as six (6) days before the day of the missed period, (i.e. as early as five (5) days before the day of the expected period). It is intended for use by people who would like to find out whether they are pregnant in a home environment. Only for use outside the body. For over-the-counter use.

Important note regarding positive results:

Because this test detects low levels of hCG, it is possible that this test may give positive results even if you are not pregnant. All results should be confirmed by your healthcare provider, especially when making decisions about future medical care.

This device is intended for home-use only.

7. Device Description

MissLan® Early Detection Pregnancy Test will be sold in Strip. Cassette and Midstream format. The Strip format is a single test strip. The Cassette format consists of a single test strip assembled in a plastic housing. The Midstream format consists of a single test strip assembled in a plastic housing with an absorbent tip, and is designed to be tested in dip or midstream mode.

MissLan® Early Detection Pregnancy Test Strip. MissLan® Early Detection Pregnancy Test Cassette and MissLan® Early Detection Pregnancy Test Midstream each contains a pouch with the device and instructions, and in addition, cassette format is packaged with pipette dropper and urine collection cup.

The devices utilize a combination of antibodies to detect hCG in urine as well as to serve as a run control. Each device contains mouse monoclonal anti-ß-hCG antibody colloidal gold conjugate pre-dried on the sample pad. Mouse monoclonal

6

anti-a-hCG antibody (on the Test Line) and goat anti mouse IgG polyclonal antibody (on the Control Line) are coated and immobilized on a nitrocellulose membrane. The result is displayed to the user in the test window as two lines for a 'Pregnant' positive result and one line for a 'Not Pregnant' negative result.

Similarities
Item	Candidate device	Predicate device
Intended use	Early detection of pregnancy	Same
Specimen	Urine	Same
Assay technical	Immunochromatographic
assay	Same
Sensitivity	10 mIU/mL	Same
Results	Qualitative	Same
Device format	Strip, Cassette, Midstream	Same
Differences
Item	Device	Predicate
Target user	For over-the-counter use	Prescription use and OTC use
Read time	3-10 minutes	5 minutes

Substantial Equivalence Information 8.

9. Test Principle

MissLan® Early Detection Pregnancy Test Strip, MissLan® Early Detection Pregnancy Test Cassette and MissLan® Early Detection Pregnancy Test Midstream use lateral flow immunoassay for in vitro qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine. If hCG is present in the sample, it will reach the Test Zone (T) of the membrane and form a colored line. When the test is performed properly, a colored line will always appear in the Control Zone (C). The test result is shown in the result window and read visually in 3 minutes of urine addition. Two distinct colored lines, one in the Test Zone (T) and another in the Control Zone (C) indicate a positive test result (pregnant). Absence of a colored line in the Test Zone (T) and only a colored line in the Control Zone (C) indicates a negative test result (not pregnant). Absence of a colored line in the Control Zone(C) even in the presence of a colored line in the Test Zone (T) indicates an invalid test result.

10. Performance Characteristics

A. Analytical performance

a. Precision/Reproducibility/Sensitivity

Negative female urine was spiked with hCG standard (Traceable to the 5th WHO) to hCG concentrations of 0, 3, 3.5 5, 6.5, 7.5, 10, 15 and 25 mIU/mL. Each sample

7

was tested in 10 replicates per day for 5 days for each device lot. Total of three device lots for each format were tested and each operator tested one lot separately. Tests were performed by three different operators for each sample concentration. The midstream format was performed using both dip and in-stream methods. The results are summarized in the table below:

| hCG
Concentration
(mIU/mL) | Operator 1
Lot I | | Operator 2
Lot II | | Operator 3
Lot III | | Total result | | %
Negative | %
Positive |
|----------------------------------|---------------------|----|----------------------|----|-----------------------|----|--------------|-----|---------------|---------------|
| | - | + | - | + | - | + | - | + | | |
| 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0 | 100% | 0% |
| 3 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0 | 100% | 0% |
| 3.5 | 44 | 6 | 45 | 5 | 45 | 5 | 134 | 16 | 89.33% | 10.67% |
| 5 | 36 | 14 | 37 | 13 | 36 | 14 | 109 | 41 | 72.67% | 27.33% |
| 6.5 | 27 | 23 | 23 | 27 | 26 | 24 | 76 | 74 | 50.67% | 49.33% |
| 7.5 | 10 | 40 | 13 | 37 | 13 | 37 | 36 | 114 | 24.00% | 76.00% |
| 10 | 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0% | 100% |
| 15 | 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0% | 100% |
| 25 | 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0% | 100% |

Strip format

Cassette format

| hCG
Concentration
(mIU/mL) | Operator 1
Lot I | | Operator 2
Lot II | | Operator 3
Lot III | | Total result | | %
Negative | %
Positive |
|----------------------------------|---------------------|----|----------------------|----|-----------------------|----|--------------|-----|---------------|---------------|
| | - | + | - | + | - | + | - | + | | |
| 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0 | 100% | 0% |
| 3 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0 | 100% | 0% |
| 3.5 | 45 | 5 | 45 | 5 | 45 | 5 | 135 | 15 | 90.00% | 10.00% |
| 5 | 37 | 13 | 35 | 15 | 35 | 15 | 107 | 43 | 71.33% | 28.67% |
| 6.5 | 23 | 27 | 26 | 24 | 24 | 26 | 73 | 77 | 48.67% | 51.33% |
| 7.5 | 11 | 39 | 13 | 37 | 10 | 40 | 34 | 116 | 22.67% | 77.33% |
| 10 | 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0% | 100% |
| 15 | 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0% | 100% |
| 25 | 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0% | 100% |

Midstream format (in-stream method)

| hCG
Concentration
(mIU/mL) | Operator 1
Lot I | | Operator 2
Lot II | | Operator 3
Lot III | | Total result | | % Negative | % Positive |
|----------------------------------|---------------------|----|----------------------|----|-----------------------|----|--------------|-----|------------|------------|
| | - | + | - | + | - | + | - | + | | |
| 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0 | 100% | 0% |
| 3 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0 | 100% | 0% |
| 3.5 | 45 | 5 | 45 | 5 | 45 | 5 | 135 | 15 | 90.00% | 10.00% |
| 5 | 37 | 13 | 36 | 14 | 37 | 13 | 110 | 40 | 73.33% | 26.67% |
| 6.5 | 24 | 26 | 26 | 24 | 24 | 26 | 74 | 76 | 49.33% | 50.67% |
| 7.5 | 11 | 39 | 12 | 38 | 14 | 36 | 37 | 113 | 24.67% | 75.33% |
| 10 | 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0% | 100% |
| 15 | 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0% | 100% |
| 25 | 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0% | 100% |

Midstream format (dip method)

8

| hCG
Concentration
(mIU/mL) | Operator 1
Lot I | | Operator 2
Lot II | | Operator 3
Lot III | | Total result | | % Negative | % Positive |
|----------------------------------|---------------------|----|----------------------|----|-----------------------|----|--------------|-----|------------|------------|
| | - | + | - | + | - | + | - | + | | |
| 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0 | 100% | 0% |
| 3 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0 | 100% | 0% |
| 3.5 | 45 | 5 | 44 | 6 | 45 | 5 | 134 | 16 | 89.33% | 10.67% |
| 5 | 37 | 13 | 36 | 14 | 35 | 15 | 108 | 42 | 72.00% | 28.00% |
| 6.5 | 23 | 27 | 24 | 26 | 26 | 24 | 73 | 77 | 48.67% | 51.33% |
| 7.5 | 12 | 38 | 14 | 36 | 9 | 41 | 35 | 115 | 23.33% | 76.67% |
| 10 | 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0% | 100% |
| 15 | 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0% | 100% |
| 25 | 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0% | 100% |

MissLan® Early Detection Pregnancy Test exhibited reproducibility of results. Based on the above results, the sensitivity of MissLan® Early Detection Pregnancy Test is demonstrated to be 10 mIU/mL.

b. Linearity/assay reportable range:

Linearity is not applicable since this is a qualitative test. The test device was evaluated for high dose or hook effect.

Hook effect test:

Negative urine samples were spiked with varying hCG concentrations (6,250 mIU/mL, 12,500 mIU/mL, 25,000 mIU/mL, 50,000 mIU/mL, 100,000 mIU/mL, 200,000 mIU/mL and 500,000 mIU/mL). The results demonstrated that no hook effect was observed at hCG concentration up to 500,000 mIU/mL.

c. Traceability, Stability, Expected values (controls, calibrators, or methods): Traceability:

MissLan® Early Detection Pregnancy Test is calibrated against reference material traceable to WHO International Standard 5th edition, NIBSC code 07/364.

Stability:

The shelf-life of the MissLan® Early Detection Pregnancy Test at 2~30℃ is 36 months based on real time stability data.

d. Analytical specificity

Interfering substance:

To evaluate potential interfering substances of the MissLan® Early Detection Pregnancy Test, urine samples containing 0 mIU/mL, 3 mIU/mL and 10 mIU/mL hCG were spiked with interfering substances to the concentrations listed below. No interference effect was observed at the tested concentrations.

Substance	Concentration
Albumin	2000 mg/dL

9

Substance	Concentration
Bilirubin	40 mg/dL
Glucose	2000 mg/dL
Hemoglobin	1000 mg/dL
Uric acid	23.5 mg/dL
Ketone	20 mg/dL
β-hydroxybutyrate	2000 mg/dL
Pregnanediol	1.5 mg/dL
Acetaminophen	20 mg/dL
Acetylsalicylic acid	80 mg/dL
Amoxicillin	20 mg/dL
Ampicillin	20 mg/dL
Ascorbic acid	20 mg/dL
Atropine	20 mg/dL
Benzoylecgonine	10 mg/dL
Caffeine	20 mg/dL
Cannabinol	10 mg/dL
Codeine	6 µg/dL
EDTA	80 mg/dL
Ephedrine	20 mg/dL
Ethanol	1%
Folic acid	0.03 mg/dL
Salicylic acid	20 mg/dL
Gentisic acid	20 mg/dL
Ibuprofen	40 mg/dL
Phenothiazine	20 mg/dL
Phenylpropanolamine	20 mg/dL
Tetracycline	20 mg/dL
Thiophene	20 mg/dL
Vitamin B1	80 mg/dL

Cross-reactivity :

To evaluate cross-reactivity, negative and positive urine samples (0 mIU/mL, 3 mIU/mL and 10 mIU/mL hCG) were spiked with potential cross reactants (500 mIU/mLhLH, 1000 mIU/mL hFSH, 1000 µIU/mL hTSH). No cross-reactivity was observed at tested concentration.

Effects of hCG ß-core fragment:

To evaluate the effect of the hCG ß-core fragment, negative urine samples (0 mIU/mL and 3 mIU/mL hCG) and positive urine samples (10 mIU/mL and 20,000 mIU/mL hCG) were spiked with hCG ß-core fragment (hCGBcf) at concentrations of 50,000 pmol/L, 125,000 pmol/L, 250,000 pmol/L and 500,000 pmol/L. The performance of MissLan® Early Detection Pregnancy Test was not affected by hCG ß-core fragment concentrations up to 500,000 pmol/L.

10

Effects of urine pH:

To evaluate the effect of urine pH on the results of MissLan® Early Detection Pregnancy Test, urine samples containing 0 mIU/mL, 3 mIU/mL and 10 mIU/mL hCG were tested at pH values of 4, 5, 6, 7, 8 and 9. The results indicated that urine pH ranges between 4 and 9 does not affect the performance of MissLan® Early Detection Pregnancy Test.

Effects of urine density:

To evaluate the effect of urine density on the results of MissLan® Early Detection Pregnancy Test, urine samples containing 0 mIU/mL, 3 mIU/mL and 10 mIU/mL hCG were tested at density values of 1.000, 1.005, 1.010, 1.015, 1.020, 1.025, 1.030 and 1.035. The results indicated that urine with a relative density rang of 1.000 to 1.035 does not affect the performance of MissLan® Early Detection Pregnancy Test.

B. Method comparison study

Method comparison with predicate device:

The performance of the candidate device was compared to the predicate device. Urine samples were collected from 400 women aged 18 to 51 at three clinical sites. Approximately half of the subjects were pregnant in the early stage of less than 5 weeks. Samples were randomly collected at various time throughout the day.

All samples were tested by three professionals at each site using the candidate device and by one professional at each site using the predicate device. 100 samples were tested for strip format, and 100 samples were tested for cassette format; for the midstream format, both dip testing (100 samples) and in-stream testing (100 samples) were evaluated. The samples were blinded and randomized before being tested by professionals. All results are summarized in the table below.

Candidate device		Predicate device
		Positive	Negative	Total
Strip format	Positive	49	0	49
	Negative	0	51	51
	Total	49	51	100
Candidate device		Predicate device
		Positive	Negative	Total
Cassette format	Positive	51	0	51
	Negative	0	49	49
	Total	51	49	100

Candidate device		Predicate device
		Positive	Negative	Total
Midstream format	Positive	48	0	48

11

| dip method) | Negative | | t The Children the Children the Children the Children the Children the Children the Children the Children the Children the Children the Children the Children the Children the
( | ﺎ ﻟﻠﺘﻌﻠﻴﻤﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍ |
|-------------|----------|---|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Total | i | t L
N I | 100 |

	Predicate device
Candidate device		Positive	Negative	Total
Midstream format
(in-stream method)	Positive	49	0	49
	Negative	0	51	51
	Total	49	51	100

The conformity between MissLan® Early Detection Pregnancy Test (strip / cassette / midstream) and the predicate device is 100%.

C. Clinical studies

1. Clinical Sensitivity:
  Not applicable.
1. Clinical Specificity:
  Not applicable.
1. Other Clinical Supportive Data (When 1. and 2. Are Not Applicable):
3.1 Lay person study

First study:

A lay user study was performed at three sites with a total of 400 females with diverse educational and occupational backgrounds and ages ranging from 18 to 51 years old. Each subject tested her own urine sample using the device according to the instructions for use and provided a sample for professional testing. 100 subjects tested the strip format, 100 subjects tested the cassette format, 100 subjects tested the midstream format using dip method, and 100 subjects tested the midstream format using in-stream method.

The results are summarized in the table below.

Strip format

	Professional
Strip format		Positive	Negative	Total
Layperson	Positive	49	0	49
	Negative	0	51	51
	Total	49	51	100

Cassette format

		Professional
Cassette format		Positive	Negative	Total
Layperson	Positive	51	0	51
	Negative	0	49	49

12

Total	51	49	100
-------	----	----	-----

Midstream format

| Midstream format

(dip method)		Professional
		Positive	Negative	Total
Layperson	Positive	48	0	48
	Negative	0	52	52
	Total	48	52	100

| | Midstream format
(in-stream method) | Professional | | |
|-----------|----------------------------------------|--------------|----------|-------|
| | | Positive | Negative | Total |
| Layperson | Positive | 49 | 0 | 49 |
| | Negative | 0 | 51 | 51 |
| | Total | 49 | 51 | 100 |

From the above tables, the lay person results showed 100% positive and 100% negative conformity with the professional results.

Second study:

Negative urine sample pools were spiked with 3 mIU/mL, 3.5 mIU/mL, 6.5 mIU/mL and 10 mIU/mL hCG. All aliquots were blind labeled by the person who prepared the samples and didn't take part in the sample testing. A total of 300 laypersons performed the testing, of which 100 using the strip format, 100 using the cassette format and 100 using the midstream format. Each layperson tested 4 blind-labeled samples (3 mIU/mL, 3.5 mIU/mL, 6.5 mIU/mL and 10 mIU/mL), and an aliquot of each of the spiked urine samples was also tested by the professional.

Results of spiked samples are summarized in the table below.

Strip format:

| hCG
Concentration
(mIU/mL) | Layperson result | | | Professional result | | | Percent
Agreement |
|----------------------------------|--------------------|--------------------|---------------|---------------------|--------------------|---------------|----------------------|
| | No. of
Positive | No. of
Negative | %
positive | No. of
Positive | No. of
Negative | %
positive | |
| 3 | 0 | 100 | 0% | 0 | 100 | 0% | 100% |
| 3.5 | 9 | 91 | 9% | 10 | 90 | 10% | 95% |
| 6.5 | 49 | 51 | 49% | 51 | 49 | 51% | 96% |
| 10 | 100 | 0 | 100% | 100 | 0 | 100% | 100% |

Cassette format:

| hCG
Concentration
(mIU/mL) | Layperson result | | | Professional result | | | Percent
Agreement |
|----------------------------------|--------------------|--------------------|---------------|---------------------|--------------------|---------------|----------------------|
| | No. of
Positive | No. of
Negative | %
positive | No. of
Positive | No. of
Negative | %
positive | |

13

3		100	0%		100	0%	100%
3.5	10	90	10%	11	89	11%	તે તે જેની જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામમાં મુખ્યત્વે ખેત
6.5	48	52	48%	22	48	52%	96%
10	100		100%	100		100%	100%

Midstream format:

| hCG
Concentration
(mIU/mL) | Layperson result | | | Professional result | | | Percent
Agreement |
|----------------------------------|--------------------|--------------------|---------------|---------------------|--------------------|---------------|----------------------|
| | No. of
Positive | No. of
Negative | %
positive | No. of
Positive | No. of
Negative | %
positive | |
| 3 | 0 | 100 | 0% | 0 | 100 | 0% | 100% |
| 3.5 | 10 | 90 | 10% | 11 | 89 | 11% | 95% |
| 6.5 | 49 | 51 | 49% | 52 | 48 | 52% | 97% |
| 10 | 100 | 0 | 100% | 100 | 0 | 100% | 100% |

The results above show that MissLan® Early Detection Pregnancy Test can be used by the laypersons and get the correct results.

3.2 Early pregnancy detection study

A study was performed to evaluate the early pregnancy detection rate of MissLan® Early Detection Pregnancy Test. A total of 650 early pregnancy urine samples from day -8 to +1 relative to the day of the expected menstrual period were collected from 65 pregnant women. Each sample was tested with each format of the MissLan® Early Detection Pregnancy Test. For the midstream format, both dip and in-stream methods were evaluated.

The specific detection rates per day are summarized in the table below. Strip format:

Test date	EMP-8	EMP-7	EMP-6	EMP-5	EMP-4	EMP-3	EMP-2	EMP-1	EMP	EMP+1
# of positive
results of B-
ultrasound	65	65	65	65	65	65	65	65	65	65
# of positive
results of HCG	1	8	25	50	63	65	65	65	65	65
Detection rate	1.54%	12.31%	38.46%	76.92%	96.92%	100%	100%	100%	100%	100%

Cassette format:

Test date	EMP-8	EMP-7	EMP-6	EMP-5	EMP-4	EMP-3	EMP-2	EMP-1	EMP	EMP+1
# of positive
results of B-
ultrasound	65	65	65	65	65	65	65	65	65	65
# of positive
results of HCG	1	8	25	50	63	65	65	65	65	65
Detection rate	1.54%	12.31%	38.46%	76.92%	96.92%	100%	100%	100%	100%	100%

Midstream format (in-stream method):

Test date	EMP-8	EMP-7	EMP-6	EMP-5	EMP-4	EMP-3	EMP-2	EMP-1	EMP	EMP+1
# of positive	65	65	65	65	65	65	65	65	65	65

14

| results of B-

ultrasound
# of positive
results of HCG	1	8	25	50	63	65	65	65	65	65
Detection rate	1.54%	12.31%	38.46%	76.92%	96.92%	100%	100%	100%	100%	100%

Midstream format (dip method):

Test date	EMP-8	EMP-7	EMP-6	EMP-5	EMP-4	EMP-3	EMP-2	EMP-1	EMP	EMP+1
# of positive
results of B-
ultrasound	65	65	65	65	65	65	65	65	65	65
# of positive
results of HCG	1	8	25	50	63	65	65	65	65	65
Detection rate	1.54%	12.31%	38.46%	76.92%	96.92%	100%	100%	100%	100%	100%

The detection rate of MissLan® Early Detection Pregnancy Test (strip/cassette/ midstream) in EMP-5 (i.e. five days before the expected menstrual period, 6 days before the missed menstrual period) was 76.92%, in EMP-4 was 96.92%, and in EMP-1 was 100%.

3.3 Specificity Study to Determine False-Positive Results Rate

900 urine samples were collected from non-pregnant females in pre-menopausal (18-40 years old), peri-menopausal (41-55 years old) and post-menopausal (>55 years old) age groups at three sites. 300 participants for each age group. In each age group, 100 participants test strip, 100 participants tested test cassette, 50 participants tested test midstream using dip method, and 50 participants tested test midstream using in-stream method. Three batches of each format were used in the study. No false positive results were observed for all age groups.

Strip format:

Group	Lot I	Lot II	Lot III	Total result
Pre-menopausal	0+/34-	0+/33-	0+/33-	0+/100-
Peri-menopausal	0+/33-	0+/34-	0+/33-	0+/100-
Post-menopausal	0+/33-	0+/33-	0+/34-	0+/100-

Cassette format:

Group	Lot I	Lot II	Lot III	Total result
Pre-menopausal	0+/34-	0+/33-	0+/33-	0+/100-
Peri-menopausal	0+/33-	0+/34-	0+/33-	0+/100-
Post-menopausal	0+/33-	0+/33-	0+/34-	0+/100-

Midstream format:

Group	Lot I	Lot II	Lot III	Total result
Pre-menopausal	0+/34-	0+/33-	0+/33-	0+/100-
Peri-menopausal	0+/33-	0+/34-	0+/33-	0+/100-
Post-menopausal	0+/33-	0+/33-	0+/34-	0+/100-

15

11. Conclusion

Based on the test principle and performance characteristics of the device including precision, cut-off, interference, specificity, method comparison, lay-user study and early pregnancy detection study of the devices, it can be concluded that MissLan® Early Detection Pregnancy Test is substantially equivalent to the predicate device.