DAVID One Step Home Use Pregnancy Test Midstream, DAVID One Step Home Use Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Cassette, DAVID One Step Home Use Pregnancy Test Cassette

K181551 · Runbio Biotech Co.,Ltd · LCX · Feb 22, 2019 · Clinical Chemistry

Device Facts

• Record ID: K181551
• Device Name: DAVID One Step Home Use Pregnancy Test Midstream, DAVID One Step Home Use Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Cassette, DAVID One Step Home Use Pregnancy Test Cassette
• Applicant: Runbio Biotech Co.,Ltd
• Product Code: LCX · Clinical Chemistry
• Decision Date: Feb 22, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

DAVID One Step Home Use Pregnancy Test Strip is an in-Vitro diagnostic test device for the qualitative detection of human chorionic gonadotropin (HCG) in the urine. The test device is intended for use as an aid in early detection of pregnancy. in some cases as early as five (5) days before the expected period, i.e., as early as six (6) days before the day of the missed period. This product is intended for over-the-counter use. DAVID One Step Home Use Pregnancy Test Cassette is an in-Vitro diagnostic test device for the qualitative detection of human chorionic gonadotropin (HCG) in the urine. The test device is intended for use as an aid in early detection of pregnancy, in some cases as early as five (5) days before the expected period, i.e., as early as six (6) days before the day of the missed period. This product is intended for over-the-counter use. DAVID One Step Home Use Pregnancy Test Midstream is an in-Vitro diagnostic test device for the qualitative detection of human chorionic gonadotropin (HCG) in the urine. The test device is intended for use as an aid in early detection of pregnancy, in some cases as early as five (5) days before the expected period, i.e., as early as six (6) days before the day of the missed period. This product is intended for over-the-counter use only. DAVID One Step Prescription Pregnancy Test Strip is an in-Vitro diagnostic test device for the qualitative detection of human chorionic gonadotropin (HCG) in the urine. The test device is intended for use as an aid in early detection of pregnancy, in some cases as early as five (5) days before the expected period, i.e., as early as six (6) days before the day of the missed period. This product is intended for prescription use. DAVID One Step Prescription Pregnancy Test Cassette is an in-Vitro diagnostic test device for the qualitative detection of human chorionic gonadotropin (HCG) in the urine. The test device is intended for use as an aid in early detection of pregnancy, in some cases as early as five (5) days before the expected period, i.e., as early as six (6) days before the day of the missed period. This product is intended for prescription use.

Device Story

Lateral flow immunoassay for qualitative hCG detection in urine; utilizes double antibody sandwich method. Mouse monoclonal anti-beta-hCG antibody-colloidal gold conjugate pre-dried on pad; mouse monoclonal anti-alpha-hCG antibody on test line; goat anti-mouse IgG on control line. Available in strip, cassette, and midstream formats. User applies urine sample; capillary action moves sample across membrane. If hCG present above 10 mIU/mL cutoff, red line appears at test line; control line confirms test validity. Used in home or clinical settings; results interpreted visually by user or healthcare provider. Provides early pregnancy detection up to 6 days before missed period. Benefits include rapid, accessible pregnancy confirmation.

Clinical Evidence

Clinical performance evaluated via 1,287 urine samples from 99 women (ages 20-40) across conception cycles (days -10 to +2 relative to expected period). Detection rates reached 100% by day 0. Lay-user study (360 participants) confirmed ease of use and interpretation. Non-pregnant urine analysis (900 samples) showed 1 false positive in post-menopausal group (>55 years). Bench testing confirmed 10 mIU/mL sensitivity and no high-dose hook effect up to 2,000,000 mIU/mL.

Technological Characteristics

Lateral flow immunochromatographic assay. Components: nitrocellulose membrane, mouse monoclonal anti-alpha-hCG (test line), goat anti-mouse IgG (control line), mouse monoclonal anti-beta-hCG colloidal gold conjugate. Formats: strip, cassette, midstream. Qualitative visual readout. Traceable to WHO 5th International Standard for hCG. No electronic components or software.

Indications for Use

Indicated for qualitative detection of human chorionic gonadotropin (hCG) in urine as an aid in early pregnancy detection. Intended for use by women of childbearing age, available for both over-the-counter and prescription use.

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

• FIRST RESPONSE Early Result Pregnancy Test (k123436)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.

February 22, 2019

Runbio BioTech Co.,Ltd Lyn Chen Official Correspondent Rongsheng Technological Zone, University Road Shantou, Guangdong 515063, China

### Re: k181551

Trade/Device Name: DAVID One Step Home Use Pregnancy Test Strip DAVID One Step Home Use Pregnancy Test Midstream DAVID One Step Home Use Pregnancy Test Cassette DAVID One Step Prescription Pregnancy Test Strip DAVID One Step Prescription Pregnancy Test Cassette Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Codes: LCX, JHI Dated: January 8, 2019 Received: January 10, 2019

Dear Lyn Chen:

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

{1}------------------------------------------------

Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Kellie B. Kelm -S

for Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

510(k) Number (if known) K181551

Device Name

DAVID One Step Prescription Pregnancy Test Strip

Indications for Use (Describe)

DAVID One Step Prescription Pregnancy Test Strip is an in-Vitro diagnostic test device for the qualitative detection of human chorionic gonadotropin (HCG) in the urine. The test device is intended for use as an aid in early detection of pregnancy, in some cases as early as five (5) days before the expected period. i.e., as early as six (6) days before the day of the missed period.

This product is intended for prescription use.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------|---------------------------------------------|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

{3}------------------------------------------------

510(k) Number (if known) K181551

Device Name

DAVID One Step Prescription Pregnancy Test Cassette

Indications for Use (Describe)

DAVID One Step Prescription Pregnancy Test Cassette is an in-Vitro diagnostic test device for the qualitative detection of human chorionic gonadotropin (HCG) in the urine. The test device is intended for use as an aid in early detection of pregnancy, in some cases as early as five (5) days before the expected period. i.e., as early as six (6) days before the day of the missed period.

This product is intended for prescription use.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------|--------------------------------------------------------------|
| <div> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

{4}------------------------------------------------

510(k) Number (if known) K181551

Device Name

DAVID One Step Home Use Pregnancy Test Strip

Indications for Use (Describe)

DAVID One Step Home Use Pregnancy Test Strip is an in-Vitro diagnostic test device for the qualitative detection of human chorionic gonadotropin (HCG) in the urine. The test device is intended for use as an aid in early detection of pregnancy, in some cases as early as five (5) days before the expected period. i.e., as early as six (6) days before the day of the missed period.

This product is intended for over-the-counter use.

Type of Use (Select one or both, as applicable)

| <span></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span></span> Over-The-Counter Use (21 CFR 801 Subpart C) |
|------------------------------------------------------------|-----------------------------------------------------------|
|------------------------------------------------------------|-----------------------------------------------------------|

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

{5}------------------------------------------------

510(k) Number (if known) K181551

Device Name

DAVID One Step Home Use Pregnancy Test Midstream

Indications for Use (Describe)

DAVID One Step Home Use Pregnancy Test Midstream is an in-Vitro diagnostic test device for the qualitative detection of human chorionic gonadotropin (HCG) in the urine. The test device is intended for use as an aid in early detection of pregnancy, in some cases as early as five (5) days before the expected period. i.e., as early as six (6) days before the day of the missed period.

This product is intended for over-the-counter use only.

Type of Use (Select one or both, as applicable)

| <span></span> | <span></span> Prescription Use (Part 21 CFR 801 Subpart D) |
|---------------|------------------------------------------------------------|
| <span></span> | <span></span> Over-The-Counter Use (21 CFR 801 Subpart C) |

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

{6}------------------------------------------------

510(k) Number (if known) K181551

Device Name

DAVID One Step Home Use Pregnancy Test Cassette

Indications for Use (Describe)

DAVID One Step Home Use Pregnancy Test Cassette is an in-Vitro diagnostic test device for the qualitative detection of human chorionic gonadotropin (HCG) in the urine. The test device is intended for use as an aid in early detection of pregnancy, in some cases as early as five (5) days before the expected period. i.e., as early as six (6) days before the day of the missed period.

This product is intended for over-the-counter use.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------------------------------------------|--|
| <div style="display:flex; align-items:center;"><input type="checkbox"/>Prescription Use (Part 21 CFR 801 Subpart D)</div> | |
| <div style="display:flex; align-items:center;"><input checked="" type="checkbox"/>Over-The-Counter Use (21 CFR 801 Subpart C)</div> | |

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

{7}------------------------------------------------

# 510(k) SUMMARY

The Assigned 510(k) number is K181551.

DATE of Summary: December 29,2018

# A. Applicant

- 1.Company Name: RUNBIO BIOTECH CO., LTD
- 2.Address: RONGSHENG TECHNOLOGICAL ZONE,UNIVERSITY ROAD

SHANTOU, GUANGDONG, CHINA 515063

- 3.Telephone No.: 86-754-88116918
- 4.Fax: [phone]

### B. Contact Information

1.Contact Person: LYN CHEN

- 2.Company Name: RUNBIO BIOTECH CO.,LTD
- 3.Address: RONGSHENG TECHNOLOGICAL ZONE.UNIVERSITY ROAD

SHANTOU, GUANGDONG, P.R.CHINA 515063

4.Telephone No.: 86-754-82758965

5.Fax No.: 86-754-88116915

6.E-mail Address:[e-mail]

### C. Proprietary and Established Names

DAVID One Step Home Use Pregnancy Test Strip

DAVID One Step Home Use Pregnancy Test Cassette

DAVID One Step Home Use Pregnancy Test Midstream

DAVID One Step Prescription Pregnancy Test Strip

DAVID One Step Prescription Pregnancy Test Cassette

#### D. Regulatory Information

1.Regulation section:

21 CFR 862.1155 Human Chorionic Gonadotropin (HCG) test system

- 2.Classification:
Class II

{8}------------------------------------------------

### 3.Product Code:

LCX: Kit, test, pregnancy, hCG, over the counter

JHI: visual, pregnancy, hcg, prescription use

4.Panel:

Chemistry (75)

#### E.Intended Use/Indication(s) for use

1.Intended Use:

See Indications for use below.

2.Indications for use:

DAVID One Step Home Use Pregnancy Test Strip is an in-Vitro diagnostic test device for the qualitative detection of human chorionic gonadotropin (HCG) in the urine. The test device is intended for use as an aid in early detection of pregnancy. in some cases as early as five (5) days before the expected period, i.e., as early as six (6) days before the day of the missed period.

This product is intended for over-the-counter use.

DAVID One Step Home Use Pregnancy Test Cassette is an in-Vitro diagnostic test device for the qualitative detection of human chorionic gonadotropin (HCG) in the urine. The test device is intended for use as an aid in early detection of pregnancy, in some cases as early as five (5) days before the expected period, i.e., as early as six (6) days before the day of the missed period.

This product is intended for over-the-counter use.

DAVID One Step Home Use Pregnancy Test Midstream is an in-Vitro diagnostic test device for the qualitative detection of human chorionic gonadotropin (HCG) in the urine. The test device is intended for use as an aid in early detection of pregnancy, in some cases as early as five (5) days before the expected period, i.e., as early as six (6) days before the day of the missed period. This product is intended for over-the-counter use only.

{9}------------------------------------------------

DAVID One Step Prescription Pregnancy Test Strip is an in-Vitro diagnostic test device for the qualitative detection of human chorionic gonadotropin (HCG) in the urine. The test device is intended for use as an aid in early detection of pregnancy, in some cases as early as five (5) days before the expected period, i.e., as early as six (6) days before the day of the missed period.

This product is intended for prescription use.

DAVID One Step Prescription Pregnancy Test Cassette is an in-Vitro diagnostic test device for the qualitative detection of human chorionic gonadotropin (HCG) in the urine. The test device is intended for use as an aid in early detection of pregnancy, in some cases as early as five (5) days before the expected period, i.e., as early as six (6) days before the day of the missed period. This product is intended for prescription use.

### 3. Special conditions for use statement(s):

DAVID One Step Home Use Pregnancy Test Strip is intended for over-the-counter use.

DAVID One Step Home Use Pregnancy Test Cassette is intended for over-the-counter use.

DAVID One Step Home Use Pregnancy Test Midstream is intended for over-the-counter use.

DAVID One Step Prescription Pregnancy Test Strip is intended for prescription use.

DAVID One Step Prescription Pregnancy Test Cassette is intended for prescription use.

- 4. Special instrument requirements:
None

{10}------------------------------------------------

### F. Device Description:

DAVID One Step Pregnancy Test is designed in three formats: strip, cassette, and midstream. Each of the devices (strip, cassette and midstream) contains a pouch with the test device and instructions for use, additional test cassette also contains a disposable plastic dropper. The test cassette and test midstream consist of a chromatographic test strip enclosed in plastic housing. The test strip contains mouse monoclonal anti-ß-hCG antibody, mouse monoclonal anti-a-hCG antibody, goat anti-mouse IgG polyclonal antibody and colloidal gold.

The added plastic housing does not affect the performance of the product, which is determined by the test strip. The only difference between the different formats is test procedure.

The test uses two lines to indicate results. The appearance of two color bands, one at the "Test line" and one at the "Control line" region means the test is "positive". The appearance of a color band at the "Control line" region but not at the "Test line" region means the test is "negative". If there are no colored bands in the "Control line" area and "Test line" region or if there is no color band in "Control line" region even there is a band in the "Test line" region; this means "invalid" test result.

### G. Substantial Equivalence Information

1.Predicate Device Name(s):

Church & Dwight Co., Inc., FIRST RESPONSE Early Result Pregnancy Test

2.Predicate 510(K)Number(s):

#### k123436

#### 3. Comparison with predicate

| Similarities | | |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|
| Item | Proposed Device | Predicate device |
| Product Name | DAVID One Step Pregnancy Test | FIRST RESPONSE Early<br>Result Pregnancy Test |
| Intended Use | aid in early detection of pregnancy | Same |
| Early Detection<br>claim | Detects pregnancy as early as 5 days before the<br>expected period or as early as 6 days before the<br>day of the missed period. | Same |
| Results | Qualitative | Same |
| Test Principle | Sandwich Immunochromatographic Assay | Same |
| Analytical<br>Sensitivity | 10mIU/mL | Same |

{11}------------------------------------------------

| Differences | | |
|----------------------------|--------------------------------------------------------------------------------------|-----------------------------------------------------------|
| Item | Proposed Device | Predicate device |
| Product Name | DAVID One Step Pregnancy Test | FIRST RESPONSE<br>Early Result<br>Pregnancy Test |
| Device format | Strip, Cassette, Midstream | Midstream |
| Intended User | Prescription use (strip and cassette) and OTC use<br>(strip, cassette and midstream) | OTC Use |
| Time to Result | 5 minutes | 3 minutes |
| Specificity | LH at 500 mIU/mL, FSH at 1000 mIU/mL, and<br>TSH at 1000 $ μ $ IU/mL | hLH and hFSH at<br>1000 mIU/mL, hTSH<br>at 1 mIU/mL |
| High Dosage<br>Hook effect | No high dosage hook effect for hCG up to<br>2000,000 mIU/mL | No high dosage hook<br>effect for hCG up to<br>500 IU/mL. |

# H. Guidance Document:

None were referenced

#### I. Test Principle:

The test is a qualitative, solid phase, double antibodies sandwich immunochromatographic assay.

During the test, hCG in the urine specimen reacts with the dye conjugate (mouse anti-ß-hCG antibody- colloidal gold conjugate specific to the beta subunit of hCG) and forms a complex. The complex migrates along the membrane to the mouse anti-a-hCG antibody test region (T), and remains captured in the T line.

### J. Performance Characteristics:

### 1. Analytical performance

#### a. Precision/Reproducibility

Dilute HCG standard with negative urine samples from healthy women to different concentrations: HCG7.5mIU/mL, HCG9mIU/mL, HCG 10mIU/mL, HCG15mIU/mL and HCG25mIU/mL.

{12}------------------------------------------------

In each site of the 3 sites, one format of reagent will be used for detection by 1 investigator. In each day of test, 10pcs of reagents from each lot, totally 3 lots, will be used for detection. Test will be conducted every other day, totally 5 days.

| hCG Concentration | LOT1 | LOT2 | LOT3 | % positive |
|-------------------|------------|------------|------------|------------|
| HCG0mIU/mL | -/-(50/50) | -/-(50/50) | -/-(50/50) | 0% |
| HCG 3mIU/mL | -/-(50/50) | -/-(50/50) | -/-(50/50) | 0% |
| HCG 6mIU/mL | -/-(49/50) | -/-(49/50) | -/-(50/50) | 1% |
| HCG 7.5mIU/mL | +/+(26/50) | +/+(24/50) | +/+(24/50) | 49% |
| HCG 9mIU/mL | +/+(49/50) | +/+(49/50) | +/+(48/50) | 97% |
| HCG 10mIU/mL | +/+(50/50) | +/+(50/50) | +/+(50/50) | 100% |
| HCG 15mIU/mL | +/+(50/50) | +/+(50/50) | +/+(50/50) | 100% |
| HCG 25mIU/mL | +/+(50/50) | +/+(50/50) | +/+(50/50) | 100% |

Table: statistics of test results by strips

Table: statistics of test results by cassettes

| hCG Concentration | LOT1 | LOT2 | LOT3 | % positive |
|-------------------|------------|------------|------------|------------|
| HCG0mIU/mL | -/-(50/50) | -/-(50/50) | -/-(50/50) | 0% |
| HCG 3mIU/mL | -/-(50/50) | -/-(50/50) | -/-(50/50) | 0% |
| HCG 6mIU/mL | -/-(49/50) | -/-(49/50) | -/-(49/50) | 2% |
| HCG 7.5mIU/mL | +/+(25/50) | +/+(26/50) | +/+(24/50) | 50% |
| HCG 9mIU/mL | +/+(49/50) | +/+(50/50) | +/+(49/50) | 98% |
| HCG 10mIU/mL | +/+(50/50) | +/+(50/50) | +/+(50/50) | 100% |
| HCG 15mIU/mL | +/+(50/50) | +/+(50/50) | +/+(50/50) | 100% |
| HCG 25mIU/mL | +/+(50/50) | +/+(50/50) | +/+(50/50) | 100% |

{13}------------------------------------------------

| hCG Concentration | LOT1 | LOT2 | LOT3 | % positive |
|-------------------|------------|------------|------------|------------|
| HCG0mIU/mL | -/-(50/50) | -/-(50/50) | -/-(50/50) | 0% |
| HCG 3mIU/mL | -/-(50/50) | -/-(50/50) | -/-(50/50) | 0% |
| HCG 6mIU/mL | -/-(50/50) | -/-(50/50) | -/-(50/50) | 0% |
| HCG 7.5mIU/mL | +/+(24/50) | +/+(24/50) | +/+(24/50) | 48% |
| HCG 9mIU/mL | +/+(47/50) | +/+(48/50) | +/+(47/50) | 95% |
| HCG 10mIU/mL | +/+(50/50) | +/+(50/50) | +/+(50/50) | 100% |
| HCG 15mIU/mL | +/+(50/50) | +/+(50/50) | +/+(50/50) | 100% |
| HCG 25mIU/mL | +/+(50/50) | +/+(50/50) | +/+(50/50) | 100% |

Table: statistics of test results by midstreams

- b. Linearity/assay reportable range:
Linearity is not applicable since this is a qualitative test.

- c. Traceability, Stability, Expected values (controls, calibrators, or methods): Traceability:
The tests is calibrated against the WHO International Standard 5th WHO Chorionic Gonadotrophin ( ( NIBSC code: 07/364 )

Stability:

The stability testing protocol and acceptance criteria used to support the shelf life were reviewed and found to be acceptable. The sponsor claims a 30-month shelf life for all three test formats when stored in the sealed foil pouch at 36-86°F (2-30°C).

Expected values :

- 1. Negative results are expected in healthy non-pregnant women.
2. The amount of hCG will vary greatly with gestational age and between individuals.

- d. Detection limit:
Select 30 healthy non-pregnant women and collect their urine samples as basic diluted urine. Separate each sample into 10 sets respectively, each of which is spiked with HCG standard to get required concentrations, respectively are : HCG0mIU/mL、 HCG3mIU/mL, HCG HCG7.5mIU/mL, HCG9mIU/mL, HCG 10mIU/mL, HCG12.5mIU/mL ,

{14}------------------------------------------------

HCG15mIU/mL and HCG25mIU/mL. There are 30 samples for each concentration. All the samples are re-numbered and divided into 4 sets,so each group of samples have 10 different concentrations and each concentration is made with negative urine sample from 30 different women. All the samples are stored below -20

There were 3 formats of reagent for assessment: strip, cassette and midstream. There were two test methods for the midstream format: the dip method and the simulated stream method. For each format, 3 lots of reagents would be used for test.

12 laboratory operators were selected to carry out this test based on different test methods. The 12 operators would be separated into 4 groups, 3 for each group, and then respectively test with strips, cassettes , midstreams (the dip method) and midstreams (the simulated stream method).

| hCG concentration | LOT1 | LOT2 | LOT2 | % positive |
|-------------------|------------|------------|------------|------------|
| HCG0mIU/mL | +/+(0/30) | +/+(0/30) | +/+(0/30) | 0% |
| HCG 3mIU/mL | +/+(0/30) | +/+(0/30) | +/+(1/30) | 1% |
| HCG5mIU/mL | +/+(1/30) | +/+(0/30) | +/+(0/30) | 1% |
| HCG 6mIU/mL | +/+(1/30) | +/+(2/30) | +/+(1/30) | 3% |
| HCG 7.5mIU/mL | +/+(15/30) | +/+(15/30) | +/+(14/30) | 48% |
| HCG 9mIU/mL | +/+(30/30) | +/+(29/30) | +/+(29/30) | 98% |
| HCG 10mIU/mL | +/+(30/30) | +/+(30/30) | +/+(30/30) | 100% |
| HCG 13mIU/mL | +/+(30/30) | +/+(30/30) | +/+(30/30) | 100% |
| HCG 15mIU/mL | +/+(30/30) | +/+(30/30) | +/+(30/30) | 100% |
| HCG 25mIU/mL | +/+(30/30) | +/+(30/30) | +/+(30/30) | 100% |

Table: Summary of Test Results by Strips

Table: Summary of Test Results by Cassettes

| hCG concentration | LOT1 | LOT2 | LOT2 | % positive |
|-------------------|------------|------------|------------|------------|
| HCG0mIU/mL | +/+(0/30) | +/+(0/30) | +/+(0/30) | 0% |
| HCG 3mIU/mL | +/+(0/30) | +/+(1/30) | +/+(0/30) | 1% |
| HCG5mIU/mL | +/+(1/30) | +/+(0/30) | +/+(1/30) | 2% |
| HCG 6mIU/mL | +/+(2/30) | +/+(1/30) | +/+(1/30) | 4% |
| HCG 7.5mIU/mL | +/+(15/30) | +/+(14/30) | +/+(16/30) | 50% |
| HCG 9mIU/mL | +/+(29/30) | +/+(30/30) | +/+(30/30) | 99% |
| HCG 10mIU/mL | +/+(30/30) | +/+(30/30) | +/+(30/30) | 100% |
| HCG13mIU/mL | +/+(30/30) | +/+(30/30) | +/+(30/30) | 100% |
| HCG 15mIU/mL | +/+(30/30) | +/+(30/30) | +/+(30/30) | 100% |
| HCG 25mIU/mL | +/+(30/30) | +/+(30/30) | +/+(30/30) | 100% |

{15}------------------------------------------------

| hCG concentration | LOT1 | LOT2 | LOT2 | % positive |
|-------------------|------------|------------|------------|------------|
| HCG0mIU/mL | +/+(0/30) | +/+(0/30) | +/+(0/30) | 0% |
| HCG 3mIU/mL | +/+(0/30) | +/+(0/30) | +/+(0/30) | 0% |
| HCG5mIU/mL | +/+(0/30) | +/+(1/30) | +/+(1/30) | 2% |
| HCG 6mIU/mL | +/+(2/30) | +/+(1/30) | +/+(1/30) | 4% |
| HCG 7.5mIU/mL | +/+(14/30) | +/+(15/30) | +/+(14/30) | 48% |
| HCG 9mIU/mL | +/+(30/30) | +/+(29/30) | +/+(30/30) | 99% |
| HCG 10mIU/mL | +/+(30/30) | +/+(30/30) | +/+(30/30) | 100% |
| HCG13mIU/mL | +/+(30/30) | +/+(30/30) | +/+(30/30) | 100% |
| HCG 15mIU/mL | +/+(30/30) | +/+(30/30) | +/+(30/30) | 100% |
| HCG 25mIU/mL | +/+(30/30) | +/+(30/30) | +/+(30/30) | 100% |

Table: Summary of Test Results by Midstreams (the dip method)

Table: Summary of Test Results by Midstreams (the simulated stream method)

| hCG concentration | LOT1 | LOT2 | LOT2 | % positive |
|-------------------|------------|------------|------------|------------|
| HCG0mIU/mL | +/+(0/30) | +/+(0/30) | +/+(0/30) | 0% |
| HCG 3mIU/mL | +/+(0/30) | +/+(0/30) | +/+(1/30) | 1% |
| HCG5mIU/mL | +/+(1/30) | +/+(1/30) | +/+(1/30) | 3% |
| HCG 6mIU/mL | +/+(2/30) | +/+(1/30) | +/+(2/30) | 6% |
| HCG 7.5mIU/mL | +/+(14/30) | +/+(14/30) | +/+(14/30) | 46% |
| HCG 9mIU/mL | +/+(30/30) | +/+(29/30) | +/+(30/30) | 99% |
| HCG 10mIU/mL | +/+(30/30) | +/+(30/30) | +/+(30/30) | 100% |
| HCG13mIU/mL | +/+(30/30) | +/+(30/30) | +/+(30/30) | 100% |
| HCG 15mIU/mL | +/+(30/30) | +/+(30/30) | +/+(30/30) | 100% |
| HCG 25mIU/mL | +/+(30/30) | +/+(30/30) | +/+(30/30) | 100% |

The results demonstrated that the analytical sensitivity of the new device (the lowest concentration that yields 100% positive results) was 10mIU/mL and the cut-off level (at which approximately half of the devices yield positive results and the remainder yield negative results) was 7.5 mIU/mL.

e. Analytical specificity:

Cross reactivity:

To evaluate cross-reactivity, 20 fresh urine specimens obtained from 10 healthy non-pregnant women and 10 healthy men were spiked with different concentrations of Lutenizing Hormone (LH), Follicle stimulating Hormone (FSH), and thyroid stimulating hormone (TSH) into negative (0 mIU/mL) and positive (10mIU/ml) samples. The results demonstrated no cross reaction with LH at 500mIU/ml, FSH at 1000 mIU/mL, and TSH at 1000μIU/mL.

{16}------------------------------------------------

# Interference:

A study was conducted to evaluate interference of specific exogenous compounds. Negative and positive hCG urine samples (10 mIU/mL) were individually spiked with the substances listed in the table below. Three devices of each format were tested. No interference was observed from the compounds at the concentrations listed below.

| Name | Concentration | Name | Concentration |
|------------|---------------|-----------|---------------|
| Glucose | 20mg/mL | Bilirubin | 20µg/mL |
| Albumin | 20mg/mL | estriol | 10μg/mL |
| Hemoglobin | 10μg/mL | | |

Table common birth control pills and progestational drugs

| Name | Concentration | Name | Concentration |
|------------------------|---------------|---------------------------------|---------------|
| Levonorgestrel | 11.8mg/mL | Ethynylestradiol<br>cyproterone | 2mg/mL |
| Bromocriptine mesylate | 2.5mg/mL | Progesterone | 100mg/mL |
| Clomiphene citrate | 50mg/mL | Medroxyprogesterone<br>acetate | 2mg/mL |
| Letrozole | 2.5mg/mL | Ethinylestradiol | 13.8mg/mL |
| | | Estradiol | 13.6mg/mL |

Table: prescription and OTC use exogenous substances

| Name | Concentration | Name | Concentration |
|----------------------|---------------|---------------------|---------------|
| Acetaminophen | 200µg/mL | Phenothiazine | 200µg/mL |
| Acetylsalicylic Acid | 200µg/mL | Phenylpropanolamine | 200µg/mL |
| Ascorbic Acid | 200µg/mL | Tetracycline | 200µg/mL |
| Ampicillin | 200µg/mL | Ephedrine | 200µg/mL |
| Atropine | 200µg/mL | Aspirin | 200µg/mL |
| Caffeine | 200µg/mL | Thiophene | 200µg/mL |
| Gentisic Acid | 200µg/mL | Salicyclic Acid | 200µg/mL |
| | | Ethanol | 1% |

{17}------------------------------------------------

| Name | Concentration | Name | Concentration |
|----------------|---------------|---------------|---------------|
| Amikacin | 15 mg/dL | Kanamycin A | 10 mg/dL |
| Amphotericin B | 10µg/mL | Kanamycin B | 10mg/dL |
| Cefdinir | 100µg/mL | Penicillin G | 100µg/mL |
| Cefuroxime | 100µg/mL | Rifampin | 5mg/dL |
| Cephradine | 100µg/mL | Spectinomycin | 100µg/mL |
| Ciprofloxin | 10µg/mL | Tobramycin | 2mg/dL |
| Gentamicin | 15mg/dL | Vancomycin | 6mg/dL |

Table: antibiotic

#### Effects of Urine pH:

A study was conducted to evaluate the effect of pH. Negative and positive hCG urine samples (10 mIU/mL) were tested across a pH range of 4-9. The results demonstrate that pH ranging from 4 to 9 in urine samples does not interfere with the performance of the test.

#### Specific Gravity:

A study was performed to evaluate the effects of urine specific gravity on the device. The device was challenged with negative urine and positive urine with specific gravity from 1.000 to 1.050. The results demonstrate that specific gravity ranging from 1.000 to 1.050 in urine samples does not interfere with the performance of the test.

#### High dose hook effect study:

The test was evaluated for high dose hook effect. Negative urine specimens were spiked with high hCG concentration of up to 2000,000 mIU/mL. All samples yielded the expected results. This study demonstrates that this device shows no hook effect up to 2,000,000 mIU/mL hCG.

#### Effects of hCG ß-core Fragment:

Interference testing was performed to evaluate whether high levels of beta core fragment interfere with the device. Negative urine hCG and positive urine samples (containing 10 mIU/mL hCG) were spiked with hCG beta core fragment at concentrations of62,500, 125,000, 250,000, and 1,000,000 pmol/L. Concentrations of hCG beta core fragment up to 1,000,000 pmol/L yielded correct

{18}------------------------------------------------

Interference from hCG p-core fragment was demonstrated at results. concentrations of 1,000,000 pmol/L.

- 2. Comparison Study:
a. Method comparison with predicate device:

Tests were conducted at 3 different sites. In each site, 120 urine samples were simultaneously double-blind tested by professionals using both predicate devices and one format of proposed devices. Simultaneously, two test methods of midstream, the dip method and the simulated stream method, would be compared.

| | | Predicate Device | | | |
|--------------------|----------|------------------|----------|--------------|--|
| | | Positive | Negative | total | |
| Proposed<br>Device | Positive | (a)52 | (b)0 | (a+b)52 | |
| Proposed<br>Device | Negative | (c)0 | (d)68 | (c+d)68 | |
| | total | (a+c)52 | (b+d)68 | (a+b+c+d)120 | |

Table: statistic analysis of data of strips

Table: statistic analysis of data of cassettes

| | | Predicate Device | | |
|--------------------|----------|------------------|----------|--------------|
| | | Positive | Negative | total |
| Proposed<br>Device | Positive | (a)64 | (b)0 | (a+b)64 |
| | Negative | (c)0 | (d)56 | (c+d)56 |
| | total | (a+c)64 | (b+d)56 | (a+b+c+d)120 |

Table: statistic analysis of data of midstream (the dip method)

| | | Predicate Device | | |
|--------------------|----------|------------------|----------|--------------|
| | | Positive | Negative | total |
| Proposed<br>Device | Positive | (a)73 | (b)0 | (a+b)73 |
| | Negative | (c)0 | (d)47 | (c+d)47 |
| | total | (a+c)73 | (b+d)47 | (a+b+c+d)120 |

{19}------------------------------------------------

| | | the dip method by proposed device | | |
|---------------------------------------------------|----------|-----------------------------------|----------|--------------|
| | | Positive | Negative | total |
| the simulated stream method by<br>proposed device | Positive | (a)73 | (b)0 | (a+b)73 |
| proposed device | Negative | (c)0 | (d)47 | (c+d)47 |
| | total | (a+c)73 | (b+d)47 | (a+b+c+d)120 |

Table: statistic analysis of data of midstream

- b. Matrix comparison:
Not applicable. The device is for use with urine samples only.

- 3. Clinical studies:
- a. Clinical Sensitivity:

Not applicable

- b. Clinical specificity:
Not applicable

- c. Other clinical supportive data (when a. and b. are not applicable):
### Detection of hCG in Early Pregnancy Clinical Samples

A total of 1287 urine samples were collected from 99 different women (20-40 years old) who planned to become pregnant. These women were followed throughout their conception cycles with urine collected from day -10 to day 2 of their expected period. These 1287 samples were then tested by laboratory technicians (one for strip, one for cassette format, and one for midstream for both dip and stream methods). Urine samples were masked and randomized by people who prepared samples but did not participate in the testing. One lot of each test device was used. At last, confirm all positive samples with ultrasound scan.

{20}------------------------------------------------

| Day relative<br>to EMP | Overall Pregnancy<br>Detection Rate (%) | Number of positive<br>samples | Number of<br>negative samples | Day in cycle relative to<br>EMP |
|------------------------|-----------------------------------------|-------------------------------|-------------------------------|---------------------------------|
| +2 | 100% | 99 | 0 | EMP+2 |
| +1 | 100% | 99 | 0 | EMP+1 |
| 0 | 100% | 99 | 0 | EMP |
| -1 | 100% | 99 | 0 | EMP-1 |
| -2 | 99% | 98 | 1 | EMP-2 |
| -3 | 99% | 98 | 1 | EMP-3 |
| -4 | 96% | 95 | 4 | EMP-4 |
| -5 | 78% | 77 | 22 | EMP-5 |
| -6 | 38%. | 38 | 61 | EMP-6 |
| -7 | 17% | 17 | 82 | EMP-7 |
| -8 | 7% | 7 | 92 | EMP-8 |
| -9 | 3% | 3 | 96 | EMP-9 |
| -10 | 0% | 0 | 99 | EMP-10 |

Table: results by strip

# Table: results by cassette

| Day relative<br>to EMP | Overall Pregnancy<br>Detection Rate (%) | Number of positive<br>samples | Number of<br>negative samples | Day in cycle relative to<br>EMP |
|------------------------|-----------------------------------------|-------------------------------|-------------------------------|---------------------------------|
| +2 | 100% | 99 | 0 | EMP+2 |
| +1 | 100% | 99 | 0 | EMP+1 |
| 0 | 100% | 99 | 0 | EMP |
| -1 | 100% | 99 | 0 | EMP-1 |
| -2 | 100% | 99 | 0 | EMP-2 |
| -3 | 98% | 97 | 2 | EMP-3 |
| -4 | 97% | 95 | 4 | EMP-4 |
| -5 | 77% | 76 | 23 | EMP-5 |
| -6 | 37%. | 37 | 62 | EMP-6 |
| -7 | 17% | 17 | 82 | EMP-7 |
| -8 | 9% | 8 | 91 | EMP-8 |
| -9 | 5% | 5 | 94 | EMP-9 |
| -10 | 0% | 0 | 99 | EMP-10 |

# Table: results by midstream (the dip method)

| Day relative<br>to EMP | Overall Pregnancy<br>Detection Rate (%) | Number of positive<br>samples | Number of<br>negative samples | Day in cycle relative to<br>EMP |
|------------------------|-----------------------------------------|-------------------------------|-------------------------------|---------------------------------|
| +2 | 100% | 99 | 0 | EMP+2 |
| +1 | 100% | 99 | 0 | EMP+1 |
| 0 | 100% | 99 | 0 | EMP |
| -1 | 100% | 99 | 0 | EMP-1 |
| -2 | 99% | 98 | 1 | EMP-2 |
| -3 | 99% | 98 | 1 | EMP-3 |
| -4 | 97% | 96 | 3 | EMP-4 |
| -5 | 77% | 76 | 23 | EMP-5 |
| -6 | 38% | 38 | 61 | EMP-6 |
| -7 | 18% | 18 | 81 | EMP-7 |
| -8 | 7% | 7 | 92 | EMP-8 |
| -9 | 3% | 3 | 96 | EMP-9 |
| -10 | 0% | 0 | 99 | EMP-10 |

{21}------------------------------------------------

| Day relative to EMP | Overall Pregnancy Detection Rate (%) | Number of positive samples | Number of negative samples | Day in cycle relative to EMP |
|---------------------|--------------------------------------|----------------------------|----------------------------|------------------------------|
| +2 | 100% | 99 | 0 | EMP+2 |
| +1 | 100% | 99 | 0 | EMP+1 |
| 0 | 100% | 99 | 0 | EMP |
| -1 | 100% | 99 | 0 | EMP-1 |
| -2 | 100% | 99 | 0 | EMP-2 |
| -3 | 100% | 99 | 0 | EMP-3 |
| -4 | 97% | 96 | 3 | EMP-4 |
| -5 | 80% | 80 | 19 | EMP-5 |
| -6 | 39% | 39 | 60 | EMP-6 |
| -7 | 19% | 19 | 80 | EMP-7 |
| -8 | 9% | 9 | 91 | EMP-8 |
| -9 | 4% | 4 | 95 | EMP-9 |
| -10 | 1% | 1 | 98 | EMP-10 |

Table: results by midstream (simulated stream method)

#### Layuser study

This study was performed at 3 sites on Chinese mainland. Chose women volunteers who had certain English reading ability and were willing to take time to assist the site to complete the test without compensation. These volunteers should have diverse educational and professional background but without corresponding medical background and their age range were between 20 and 40 years old.

Each unit completed the selection of 120 volunteers to conduct this lay user study, of which 50 were pregnant women and 70 were non-pregnant women.

Each site completed a study of a format, and the midstream format was used for test by simulated stream method and dip method.

All volunteers, after reading the English manual of the corresponding format of the product provided by the applicant, independently completed the collection, detection and result judgment of their urine samples without the assistance of professionals. The simultaneously collected urine samples by the volunteers were detected by professionals after blinded (the people who blinded the samples do not participate in the test). The test results of the professional and non-professional were summarized as follows:

{22}------------------------------------------------

results by professionals Positive Negative total Proposed Device Positive (a)50 (b)0 (a+b)50 results by Negative (d)70 (c)0 (c+d)70 non-professionals (a+b+c+d)120 total (a+c)50 (b+d)70

Table: statistic analysis of data of strips

Table: statistic analysis of data of cassettes

| | | results by professionals | | |
|----------------------------------------------------|----------|--------------------------|----------|--------------|
| | | Positive | Negative | total |
| Proposed Device<br>results by<br>non-professionals | Positive | (a)50 | (b)0 | (a+b)50 |
| Proposed Device<br>results by<br>non-professionals | Negative | (c)0 | (d)70 | (c+d)70 |
| Proposed Device<br>results by<br>non-professionals | total | (a+c)50 | (b+d)70 | (a+b+c+d)120 |

Table: statistic analysis of data of midstreams

| | | results by professionals | | |
|----------------------------------------------------|----------|--------------------------|----------|--------------|
| | | Positive | Negative | total |
| Proposed Device<br>results by<br>non-professionals | Positive | (a)50 | (b)0 | (a+b)50 |
| | Negative | (c)0 | (d)70 | (c+d)70 |
| | total | (a+c)50 | (b+d)70 | (a+b+c+d)120 |

Table: statistic analysis of data of midstreams (non-professionals)

| | | the dip method with proposed device | | |
|--------------------------------------------------------|----------|-------------------------------------|-----------|----------------|
| | | Positive | Negative | total |
| the simulated stream<br>method with<br>proposed device | Positive | $(a)50$ | $(b)0$ | $(a+b)50$ |
| the simulated stream<br>method with<br>proposed device | Negative | $(c)0$ | $(d)70$ | $(c+d)70$ |
| | total | $(a+c)50$ | $(b+d)70$ | $(a+b+c+d)120$ |

The second study is conducted with diluted samples.

120 volunteers at each site detect 4 samples containing different concentration of HCG, HCG 5mIU/mL, HCG 8mIU/mL, HCG 10mIU/mL and HCG11.5mIU/mL, after collection of their own urine samples. The midstream format will be used for detection in the dip method and the simulated stream method. The testing was performed at 3 intended use sites. One lot of each of the three test formats were used in the study.

{23}------------------------------------------------

| | | Lay users Results | | |
|----------------|-------------|--------------------|--------------------|------------|
| concentration | Test Sample | Number of Positive | Number of Negative | % positive |
| | | | | |
| HCG 5mUI/mL | Sample 1 | 2 | 118 | 2% |
| HCG 10mIU/mL | Sample 2 | 120 | 0 | 100% |
| HCG 11.5mIU/mL | Sample 3 | 120 | 0 | 100% |
| HCG 8mIU/mL | Sample 4 | 52 | 68 | 43% |

Table: Statistical table of test results of samples spiked with HCG (Strip )

Table: Statistical table of test results of samples spiked with HCG (Cassette )

| concentration | Test Sample | Lay users Results | | % positive |
|----------------|-------------|--------------------|--------------------|------------|
| | | Number of Positive | Number of Negative | |
| HCG 5mUI/mL | Sample 1 | 1 | 119 | 1% |
| HCG 10mIU/mL | Sample 2 | 120 | 0 | 100% |
| HCG 11.5mIU/mL | Sample 3 | 120 | 0 | 100% |
| HCG 8mIU/mL | Sample 4 | 55 | 65 | 46% |

Table: Statistical table of test results of samples spiked with HCG (Midstream)

| | | Lay users Results | | |
|----------------|-------------|-----------------------|-----------------------|------------|
| concentration | Test Sample | Number of<br>Positive | Number of<br>Negative | % positive |
| HCG 5mUI/mL | Sample 1 | 1 | 119 | 1% |
| HCG 10mIU/mL | Sample 2 | 120 | 0 | 100% |
| HCG 11.5mIU/mL | Sample 3 | 120 | 0 | 100% |
| HCG 8mIU/mL | Sample 4 | 54 | 66 | 45% |

The results show that when use the product to detect samples spiked with HCG at concentrations which are above or below the detection limit (HCG10mIU/mL), for samples whose HCG concentrations are 5mIU/mL, 1-2 of the test results is positive, and for samples whose HCG concentrations are 10mIU/mL, all the results are positive.

Because this test detects low levels of hCG, it is possible that this test may give positive results even if you are not pregnant. If you test positive, but think you may not be pregnant, you should check with your doctor.

360 volunteers who have finished the study with clinical samples were willing to do a questionnaire survey. All the questions in the questionnaire were in Likert scale style. At the same time, a Flesch-Kincaid reading analysis is performed on each package insert and the score demonstrates a reading Grade Level of 8.The

{24}------------------------------------------------

results of the questionnaire reflects that the consumers find the device easy to use and that they do not have trouble understanding the labeling or interpreting results.

# Non-pregnant urine sample analysis :

A total of 900 samples were tested in three clinical trial sites by professionals. In each unit, there were 100 samples for each age group, and one format of device from 3 lots would be used for detection.

| Age Group | Test Result | |
|---------------------------------|-------------|--------------|
| | Positive | Negative |
| pre-menopausal group<br>(18-40) | +/+(0/300) | -/-(300/300) |
| menopausal group<br>(41-55) | +/+(0/300) | -/-(300/300) |
| post menopausal group<br>(> 55) | +/+(1/300) | -/-(299/300) |

Table: statistics of test results

As can be seen from the test results in the above table, 1 false positive result occurred in non-pregnant women over 55 years old. The concentrations of these samples were determined to be higher than the cut-off of the device by quantitative test.

- 3.Clinical cut-off:
Not applicable

- 4. Expected values/Reference range:
Not applicable.

#### M. Proposed Labeling:

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

# N. CONCLUSION:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.