HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Cassette (Colloidal Gold), HCG Home Use Pregnancy Test Midstream (Colloidal Gold)
Device Facts
| Record ID | K240242 |
|---|---|
| Device Name | HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Cassette (Colloidal Gold), HCG Home Use Pregnancy Test Midstream (Colloidal Gold) |
| Applicant | Anhui Deepblue Medical Technology Co., Ltd. |
| Product Code | LCX · Clinical Chemistry |
| Decision Date | Oct 11, 2024 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1155 |
| Device Class | Class 2 |
Intended Use
The HCG Home Use Pregnancy Test Strip (Colloidal Gold) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. The test strip is designed for over-the-counter use. Important note regarding positive results: this test may give positive results even if you are not pregnant. All results should be confirmed by your healthcare providers, especially when making decisions about future medical care. This device is intended for home use only. The HCG Home Use Pregnancy Test Cassette (Colloidal Gold) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. The test cassette is designed for over-the-counter use. Important note regarding positive results: this test may give positive results even if you are not pregnant. All results should be confirmed by your healthcare providers, especially when making decisions about future medical care. This device is intended for home use only. The HCG Home Use Pregnancy Test Midstream (Colloidal Gold) is a rapid chromatographic immunoassay for the quantitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. The test midstream is designed for the over-the-counter use. Important note regarding positive results: this test may give positive results even if you are not pregnant. All results should be confirmed by your healthcare providers, especially when making decisions about future medical care. This device is intended for home use only.
Device Story
Rapid chromatographic immunoassay for qualitative hCG detection in urine; utilizes monoclonal hCG antibodies and colloidal gold tracer. Specimen migrates via capillary action; positive results indicated by red line at test region; control line confirms procedural validity. Available in strip, cassette, and midstream formats. Intended for over-the-counter home use by lay users. Results provide early pregnancy indication; positive results require clinical confirmation by healthcare providers for medical decision-making.
Clinical Evidence
Bench testing only. Precision studies (single-site/single-day, single-site/multi-day, multi-site) performed with 60-900 replicates per concentration (0-100 mIU/mL). Interference testing (endogenous/exogenous substances, pH, specific gravity, β-core fragment) showed no interference. Method comparison study (n=300) and lay-user study (n=300) demonstrated 100% agreement with professional testing using the predicate device.
Technological Characteristics
Lateral flow sandwich immunochromatographic assay. Components: nitrocellulose membrane with anti-rat-α-hCG monoclonal antibody test line; glass fiber pad with gold nanoparticle-conjugated anti-rat-β-hCG monoclonal antibody; goat anti-mouse polyclonal control line. Formats: strip, cassette (with dropper/cup), or midstream (plastic housing). No electronic components; visual readout.
Indications for Use
Indicated for qualitative detection of hCG in urine to aid early pregnancy detection. Intended for over-the-counter, home use by women of childbearing age.
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
- hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream (K200133)
Related Devices
- K041748 — AZOG, INC. HCG ONE-STEP URINE HOME PREGNANCY TEST (DIP STICK, CASSETTE AND MIDSTREAM) · Azog, Inc. · Aug 9, 2004
- K243573 — FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test Midstream · Assure Tech., LLC · Jan 15, 2025
Submission Summary (Full Text)
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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 is a blue rectangle with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Anhui DEEPBLUE Medical Technology Co. LTD. % Boyle Wang Manager Shanghai Truthful Information Technology Co., Ltd. Room 1801, No. 161 East Lujiazui Rd., Pudong Shanghai, 200120 China
Re: K240242
Trade/Device Name: HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Cassette (Colloidal Gold), HCG Home Use Pregnancy Test Midstream (Colloidal Gold). Regulation Number: 21 CFR 862.1155 Regulation Name: Human Chorionic Gonadotropin Regulatory Class: Class II Product Code: LCX
Dated: September 2, 2024 Received: September 5, 2024
Dear Boyle Wang:
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.
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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
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).
Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-regulatory
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assistance/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,
Image /page/2/Picture/3 description: The image shows a digital signature. The signature is for Joseph A. Kotarek -S. The date of the signature is 2024.10.11, and the time is 11:00:20 -04'00'.
Joseph Kotarek, Ph.D. Branch Chief Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K240242
Device Name
HCG Home Use Pregnancy Test Strip (Colloidal Gold) HCG Home Use Pregnancy Test Cassette (Colloidal Gold) HCG Home Use Pregnancy Test Midstream (Colloidal Gold)
Indications for Use (Describe)
The HCG Home Use Pregnancy Test Strip (Colloidal Gold) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy.
The test strip is designed for over-the-counter use.
Important note regarding positive results: This test may give positive results even if you are not pregnant. All results should be confirmed by your healthcare providers, especially when making decisions about future medical care. This device is intended for home use only.
The HCG Home Use Pregnancy Test Cassette (Colloidal Gold) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. The test cassette is designed for over-the-counter use.
Important note regarding positive results: This test may give positive results even if you are not pregnant. All results should be confirmed by your healthcare providers, especially when making decisions about future medical care. This device is intended for home use only.
The HCG Home Use Pregnancy Test Midstream (Colloidal Gold) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. The test midstream is designed for over-the-counter use.
Important note regarding positive results: This test may give positive results even if you are not pregnant. All results should be confirmed by your healthcare providers, especially when making decisions about future medical care. This device is intended for home use only.
| Type of Use ( <i>Select one or both, as applicable</i> ) |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> <input checked="true" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
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# 510(k) Summary
# K240242
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR 807.92.
# A. Submitter's Information
| Name: | ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD. |
|----------|--------------------------------------------------------------------------------------------------------|
| Address: | No.777 Jimingshan Road, High-Tech Development Zone,<br>230088 Hefei, Anhui, PEOPLE'S REPUBLIC OF CHINA |
| Tel: | +86-551- 65326797 |
| Contact: | Ms. Fengling Chen |
# B. Designated Submission Correspondent
| Contact: | Mr. Boyle Wang |
|----------|-----------------------------------------------------------------------|
| Name: | Shanghai Truthful Information Technology Co., Ltd. |
| Address: | Room 1801, No. 161 East Lujiazui Rd., Pudong Shanghai<br>200120 China |
| Tel: | +86-21-50313932 |
| Email: | Info@truthful.com.cn |
Date prepared: Oct.11th,2024
## C. Device Information
| Trade/Device name: | HCG Home Use Pregnancy Test Strip (Colloidal Gold), |
|--------------------|--------------------------------------------------------|
| | HCG Home Use Pregnancy Test Cassette (Colloidal Gold), |
| | HCG Home Use Pregnancy Test Midstream (Colloidal Gold) |
| Common name: | Human Chorionic Gonadotropin (HCG) test |
| Product Code: | LCX: Kit, Test, Pregnancy, hCG, over the counter |
| Classification: | Class II |
| Regulation Number: | 21 CFR 862.1155 |
| Panel: | 75-Clinical Chemistry |
# D. Predicate Device Information
# Predicate Device#:
| Manufacturer: | Safecare Biotech (Hangzhou) Co., Ltd. |
|---------------|---------------------------------------|
|---------------|---------------------------------------|
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| Trade/Device Name: | hCG Urine Test Strip |
|--------------------|--------------------------|
| | hCG Urine Test Cassette |
| | hCG Urine Test Midstream |
| 510(k) number: | K200133 |
# E. Device Description
The HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Cassette (Colloidal Gold) and HCG Home Use Pregnancy Test Midstream (Colloidal Gold) utilize a combination of antibodies including a monoclonal HCG antibody to selectively detect elevated levels of HCG. The detection method is to observe the formation of colored lines when testing urine samples with test devices. The specimen migrates via capillary action along the membrane to react with the colored conjugate. Positive specimens react with the specific antibody-HCG-colored conjugate and form a red colored line at the test line region of the membrane. The absence of this colored line suggests a negative result. To serve as a procedural control, a colored line will always appear in the control line region if the test has been performed properly. HCG Pregnancy Test will be sold in three different formats: Cassette, Strip, and Midstream. The Test Strip and Midstream format contain a test device sealed in a desiccated aluminum pouch and an Instruction. The Cassette format contains a test device, a dropper, a collection container and an Instruction. The test uses two red lines to indicate results. Two distinct red lines appear in the control region (C) and test region (T) means the test is "positive". Only one red line appears in the control region(C). No apparent line in the test region (T). means the
test is "negative". If No coloured line appears in the control region (C), or if there is no color band in control region (C) even there is a band in the test region (T),this means "invalid" test result.
## F. Indication for Use Statement
The HCG Home Use Pregnancy Test Strip (Colloidal Gold) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy.
The test strip is designed for over-the-counter use.
Important note regarding positive results: This test may give positive results even if you are not pregnant. All results should be confirmed by your healthcare providers, especially when making decisions about future medical care.
## This device is intended for home use only.
The HCG Home Use Pregnancy Test Cassette (Colloidal Gold) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy.
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The test cassette is designed for over-the-counter use.
Important note regarding positive results: This test may give positive results even if you are not pregnant. All results should be confirmed by your healthcare providers, especially when making decisions about future medical care.
# This device is intended for home use only.
The HCG Home Use Pregnancy Test Midstream (Colloidal Gold) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. The test midstream is designed for over-the-counter use.
Important note regarding positive results: This test may give positive results even if you are not pregnant. All results should be confirmed by your healthcare providers, especially when making decisions about future medical care.
## This device is intended for home use only.
| Item | Subject Device<br>(K240242) | Predicate Device<br>(K200133) |
|----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| Product Name | HCG Home Use Pregnancy Test<br>Strip (Colloidal Gold),<br>HCG Home Use Pregnancy Test<br>Cassette (Colloidal Gold),<br>HCG Home Use Pregnancy Test<br>Midstream (Colloidal Gold) | hCG Urine Test Strip<br>hCG Urine Test Cassette<br>hCG Urine Test Midstream |
| Intended Use | Aid in early detection of pregnancy | Early detection of pregnancy |
| Intended User | OTC use | OTC use |
| Sample Matrix | Urine | Same |
| Test Principle | Immunochromatographic assay | Immunochromatographic assay |
| Read time | 5 minutes | 3-5 minutes |
| Traceability | WHO International Standard 5th<br>WHO Chorionic Gonadotrophin | Same |
| Format | Strip, Cassette, Midstream | Strip, Cassette, Midstream |
| Result | Qualitative | Qualitative |
| Antibodies | Monoclonal HCG-α antibody and<br>goat anti-mouse IgG polyclonal<br>antibody on the nitrocellulose<br>mem-brane with colloidal gold<br>marked anti-HCG-β mono-clonal<br>antibody as an mark tracer. | Same |
## G. Technological Characteristic Comparison Table
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| Analytical<br>Sensitivity | 25mIU/mL | 25mIU/mL |
|----------------------------------|--------------------------------------------------------------|-------------------------------------------------------------|
| Specificity | LH at 500 mIU/mL, FSH at 1000 mIU/mL, and TSH at 1000 µIU/mL | Same |
| pH Interference | No interference for urine with pH 3-9 | Same |
| Specific Gravity<br>Interference | No interference for urine with Specific Gravity 1.000-1.035 | No interference for urine with Specific Gravity 1.001-1.039 |
| High Dosage<br>Hook effect | No high dosage hook effect for hCG up to 1,000,000 mIU/mL | No high dosage hook effect for hCG up to 850,000 mIU/mL |
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# H. Standards/Guidance Documents Referenced
Guidance for Over-the Counter (OTC) Human Chorionic Gonadotropin (hCG) 510(k)s
#### l. Test Principle
The HCG Home Use Pregnancy Test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. It utilizes a combination of antibodies including a monoclonal HCG antibody to selectively detect elevated levels of HCG. The assay is conducted by filling the urine specimen to sample well and observing the formation of red-colored lines. The specimen migrates via capillary action along the membrane to react with the colored conjugate. Positive specimens react with the specific antibody-HCG-colored conjugate and form a red colored line at the test line region of the membrane. The absence of this red colored line suggests a negative result. To serve as a procedural control, a red colored line will always appear in the control line region if the test has been performed properly.
# J. Performance Characteristics
# 1. Analytical performance
- a) Precision/Reproducibility
a.1) Sensitivity, Intra-batch precision, Inter-batch precision
A pooled negative female urine was spiked with hCG (traceable to WHO 5th IS) to provide six urine standards with the hCG concentrations of 0,12.5,18.75,25,50,100mlU/ml. using 3 lots of each format of the candidate device were tested by different operator. The samples were blinded and randomized. The sensitivity is 25 mlU/mL hCG. The results are summarized in the tables below:
| HCG concentration<br>(mIU/mL) | Lot 1 | | Lot 2 | | Lot 3 | | Total result | | Positive<br>(%) | Negative<br>(%) |
|-------------------------------|-------|----|-------|----|-------|----|--------------|----|-----------------|-----------------|
| | + | - | + | - | + | - | + | - | | |
| 0 | 0 | 20 | 0 | 20 | 0 | 20 | 0 | 60 | 0 | 100 |
| 12.5 | 0 | 20 | 0 | 20 | 0 | 20 | 0 | 60 | 0 | 100 |
| 18.75 | 8 | 12 | 9 | 11 | 8 | 12 | 25 | 35 | 41.67 | 58.33 |
| 25 | 20 | 0 | 20 | 0 | 20 | 0 | 60 | 0 | 100 | 0 |
| 50 | 20 | 0 | 20 | 0 | 20 | 0 | 60 | 0 | 100 | 0 |
| 100 | 20 | 0 | 20 | 0 | 20 | 0 | 60 | 0 | 100 | 0 |
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| HCG concentration<br>(mIU/mL) | Lot 4 | | Lot 5 | | Lot 6 | | Total result | | Positive<br>(%) | Negative<br>(%) |
|-------------------------------|-------|----|-------|----|-------|----|--------------|----|-----------------|-----------------|
| | + | - | + | - | + | - | + | - | | |
| 0 | 0 | 20 | 0 | 20 | 0 | 20 | 0 | 60 | 0 | 100 |
| 12.5 | 0 | 20 | 0 | 20 | 0 | 20 | 0 | 60 | 0 | 100 |
| 18.75 | 9 | 11 | 8 | 12 | 8 | 12 | 25 | 35 | 41.67 | 58.33 |
| 25 | 20 | 0 | 20 | 0 | 20 | 0 | 60 | 0 | 100 | 0 |
| 50 | 20 | 0 | 20 | 0 | 20 | 0 | 60 | 0 | 100 | 0 |
| 100 | 20 | 0 | 20 | 0 | 20 | 0 | 60 | 0 | 100 | 0 |
#### Table a-1-2: The results of HCG Home Use Pregnancy Test Strip (Colloidal Gold)
Table a-1-3: The Results of HCG Home Use Pregnancy Test Midstream (Colloidal Gold)
| HCG concentration<br>(mIU/mL) | Lot 7 | | Lot 8 | | Lot 9 | | Total result | | Positive<br>(%) | Negative<br>(%) |
|-------------------------------|-------|----|-------|----|-------|----|--------------|----|-----------------|-----------------|
| | + | - | + | - | + | - | + | - | | |
| 0 | 0 | 20 | 0 | 20 | 0 | 20 | 0 | 60 | 0 | 100 |
| 12.5 | 0 | 20 | 0 | 20 | 0 | 20 | 0 | 60 | 0 | 100 |
| 18.75 | 9 | 11 | 8 | 12 | 8 | 12 | 25 | 35 | 41.67 | 58.33 |
| 25 | 20 | 0 | 20 | 0 | 20 | 0 | 60 | 0 | 100 | 0 |
| 50 | 20 | 0 | 20 | 0 | 20 | 0 | 60 | 0 | 100 | 0 |
| 100 | 20 | 0 | 20 | 0 | 20 | 0 | 60 | 0 | 100 | 0 |
a.2) Inter-day Precision and Inter-round Precision
A pooled negative female urine was spiked with hCG (traceable to WHO 5th IS) to provide six urine standards with the the hCG concentrations of 0,12.5,18.75,25,50,100mlU/ml. Over a period of 5 days, with 2 run of testing each day, three operators tested the blinded and randomized samples using 3 lots of each format of candidate device.
| HCG concentration<br>(mIU/mL) | Lot 1 | | Lot 2 | | Lot 3 | | Total result | | Positive<br>(%) | Negative<br>(%) |
|-------------------------------|-------|-----|-------|-----|-------|-----|--------------|-----|-----------------|-----------------|
| | + | - | + | - | + | - | + | - | | |
| 0 | 0 | 200 | 0 | 200 | 0 | 200 | 0 | 600 | 0 | 100 |
| 12.5 | 0 | 200 | 0 | 200 | 0 | 200 | 0 | 600 | 0 | 100 |
| 18.75 | 85 | 115 | 89 | 111 | 86 | 114 | 260 | 340 | 43.33 | 56.67 |
| 25 | 200 | 0 | 200 | 0 | 200 | 0 | 600 | 0 | 100 | 0 |
| 50 | 200 | 0 | 200 | 0 | 200 | 0 | 600 | 0 | 100 | 0 |
| 100 | 200 | 0 | 200 | 0 | 200 | 0 | 600 | 0 | 100 | 0 |
Table a-2-1:The Results of HCG Home Use Pregnancy Test Cassette (Colloidal Gold)
| Table a-2-2:The Results of HCG Home Use Pregnancy Test Strip (Colloidal Gold) | | |
|-------------------------------------------------------------------------------|--|--|
| | | |
| HCG concentration<br>(mIU/mL) | Lot 4 | | Lot 5 | | Lot 6 | | Total result | | Positive<br>(%) | Negative<br>(%) |
|-------------------------------|-------|-----|-------|-----|-------|-----|--------------|-----|-----------------|-----------------|
| | + | - | + | - | + | - | + | - | | |
| 0 | 0 | 200 | 0 | 200 | 0 | 200 | 0 | 600 | 0 | 100 |
| 12.5 | 0 | 200 | 0 | 200 | 0 | 200 | 0 | 600 | 0 | 100 |
| 18.75 | 87 | 113 | 87 | 113 | 88 | 112 | 262 | 338 | 43.67 | 56.33 |
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| 25 | 200 | 0 | 200 | 0 | 200 | 0 | 600 | 0 | 100 | 0 |
|-----|-----|---|-----|---|-----|---|-----|---|-----|---|
| 50 | 200 | 0 | 200 | 0 | 200 | 0 | 600 | 0 | 100 | 0 |
| 100 | 200 | 0 | 200 | 0 | 200 | 0 | 600 | 0 | 100 | 0 |
Table a-2-3:The Results of HCG Home Use Pregnancy Test Midstream (Colloidal Gold)
| HCG concentration<br>(mIU/mL) | Lot 7 | | Lot 8 | | Lot 9 | | Total result | | Positive<br>(%) | Negative<br>(%) |
|-------------------------------|-------|-----|-------|-----|-------|-----|--------------|-----|-----------------|-----------------|
| | + | - | + | - | + | - | + | - | | |
| 0 | 0 | 200 | 0 | 200 | 0 | 200 | 0 | 600 | 0 | 100 |
| 12.5 | 0 | 200 | 0 | 200 | 0 | 200 | 0 | 600 | 0 | 100 |
| 18.75 | 82 | 118 | 87 | 113 | 86 | 114 | 255 | 345 | 42.5 | 57.5 |
| 25 | 200 | 0 | 200 | 0 | 200 | 0 | 600 | 0 | 100 | 0 |
| 50 | 200 | 0 | 200 | 0 | 200 | 0 | 600 | 0 | 100 | 0 |
| 100 | 200 | 0 | 200 | 0 | 200 | 0 | 600 | 0 | 100 | 0 |
#### a.3) Inter-laboratory precision
A pooled negative female urine was spiked with hCG (traceable to WHO 5th IS) to provide six urine standards with the hCG concentrations of 0,12.5,18.75,25, 50, 100mlU/ml. The tests were performed on 3 sites using three lots of each format of candidate device. The samples were blinded and randomized.
| HCG<br>concentration<br>(mIU/mL) | Site 1<br>(Lot 1, Lot 2,<br>Lot3) | | Site 2<br>(Lot 1, Lot 2,<br>Lot3) | | Site 3<br>(Lot 1, Lot 2,<br>Lot3) | | Total result | | Positive<br>(%) | Negative<br>(%) |
|----------------------------------|-----------------------------------|-----|-----------------------------------|-----|-----------------------------------|-----|--------------|-----|-----------------|-----------------|
| | + | - | + | - | + | - | + | - | | |
| 0 | 0 | 300 | 0 | 300 | 0 | 300 | 0 | 900 | 0% | 100% |
| 12.5 | 0 | 300 | 0 | 300 | 0 | 300 | 0 | 900 | 0% | 100% |
| 18.75 | 150 | 150 | 150 | 150 | 150 | 150 | 450 | 450 | 50% | 50% |
| 25 | 300 | 0 | 300 | 0 | 300 | 0 | 900 | 0 | 100% | 0% |
| 50 | 300 | 0 | 300 | 0 | 300 | 0 | 900 | 0 | 100% | 0% |
| 100 | 300 | 0 | 300 | 0 | 300 | 0 | 900 | 0 | 100% | 0% |
Table a-3-1:The Results of HCG Home Use Pregnancy Test Cassette (Colloidal Gold)
# Table a-3-2:The Results of HCG Home Use Pregnancy Test Strip (Colloidal Gold)
| HCG<br>concentration<br>(mIU/mL) | Site 1<br>(Lot 4, Lot 5,<br>Lot 6) | | Site 2<br>(Lot 4, Lot 5,<br>Lot 6) | | Site 3<br>(Lot 4, Lot 5,<br>Lot 6) | | Total result | | Positive<br>(%) | Negative<br>(%) |
|----------------------------------|------------------------------------|-----|------------------------------------|-----|------------------------------------|-----|--------------|-----|-----------------|-----------------|
| | + | - | + | - | + | - | + | - | | |
| 0 | 0 | 300 | 0 | 300 | 0 | 300 | 0 | 900 | 0% | 100% |
| 12.5 | 0 | 300 | 0 | 300 | 0 | 300 | 0 | 900 | 0% | 100% |
| 18.75 | 150 | 150 | 150 | 150 | 140 | 160 | 440 | 460 | 48.89% | 51.11% |
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| 25 | 300 | 0 | 300 | 0 | 300 | 0 | 900 | 0 | 100% | 0% |
|-----|-----|---|-----|---|-----|---|-----|---|------|----|
| 50 | 300 | 0 | 300 | 0 | 300 | 0 | 900 | 0 | 100% | 0% |
| 100 | 300 | 0 | 300 | 0 | 300 | 0 | 900 | 0 | 100% | 0% |
Table a-3-3:The Results of HCG Home Use Pregnancy Test Midstream (Colloidal Gold)
| HCG<br>concentration<br>(mIU/mL) | Site 1<br>(Lot 7, Lot 8,<br>Lot 9) | | Site 2<br>(Lot 7, Lot 8,<br>Lot 9) | | Site 3<br>(Lot 7, Lot 8,<br>Lot 9) | | Total result | | Positive<br>(%) | Negative<br>(%) |
|----------------------------------|------------------------------------|-----|------------------------------------|-----|------------------------------------|-----|--------------|-----|-----------------|-----------------|
| | + | - | + | - | + | - | + | - | | |
| 0 | 0 | 300 | 0 | 300 | 0 | 300 | 0 | 900 | 0% | 100% |
| 12.5 | 0 | 300 | 0 | 300 | 0 | 300 | 0 | 900 | 0% | 100% |
| 18.75 | 130 | 170 | 150 | 150 | 140 | 160 | 420 | 480 | 46.67% | 53.53% |
| 25 | 300 | 0 | 300 | 0 | 300 | 0 | 900 | 0 | 100% | 0% |
| 50 | 300 | 0 | 300 | 0 | 300 | 0 | 900 | 0 | 100% | 0% |
| 100 | 300 | 0 | 300 | 0 | 300 | 0 | 900 | 0 | 100% | 0% |
#### b) Linearity/Assay Reportable Range
Linearity is not applicable since this is a qualitative test.
- c) Traceability
The tests are calibrated against the WHO 5th International Standards for hCG.
- d) Stability
A shelf-life stability test of the devices was performed in real-time and accelerated testing. The results showed that the devices were stable for 36 months when stored at 4~30°C in the sealed foil pouch.
- e) Detection Limits (Sensitivity)
Precision section above. According to the results of precision data above, the sensitivity of HCG Urine Test is 25mlU/ml.
- f) Analytical Specificity f.1) Cross reactivity:
Negative and positive female urine contain 12.5mlU/mL and 25 mlU/ml hCG were spiked with various concentrations of the following potential cross reactants: hLH, hFSH, and hTSH. The samples were tested using 3 lots of the test kits. No cross reactivity was observed on the HCG Pregnancy Test
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#### Strip/cassette/
midstream at the concentrations tested below:
| Reactant | Concentration at which no significant<br>interference was observed |
|-------------------------------------------|--------------------------------------------------------------------|
| Human luteinizing hormone (hLH) | 500 mIU/mL |
| Human follicle stimulating hormone (hFSH) | 1000 mIU/mL |
| Human thyrotropin (hTSH) | 1 mIU/mL |
#### f.2) Interference:
To evaluate the potential interference of certain exogenous compounds, dilute each interfering substance to the required concentration and add interfering substances to female urine samples containing 0mlU/mL, 10mlU/mL and 25mIU/mL hCG to obtain the required detection samples. Three batches of each format were tested.
The results show that no interferences were observed from substance at the following concentrations for both negative and positive HCG urine samples.
| Interfering Substance | Concentration at which no significant<br>interference was observed |
|---------------------------|--------------------------------------------------------------------|
| Glucose | 2000mg/dL |
| Protein | 5.65mmol/L |
| Albumin | 2000mg/dL |
| Bilirubin | 2mg/ml |
| Hemoglobin | 1000mg/dL |
| Caffeine | 20mg/dL |
| Ascorbic acid (Vitamin C) | 20mg/dL |
| Acetaminophen | 20mg/mL |
| Aspirin | 20mg/dL |
| Tetracycline | 20mg/dL |
| Ampicillin | 20mg/dL |
| Erythrocytes | >250/μL |
| Leukocyte | >500/μL |
| Uric acid | 450mmol/L |
| Ketone | >80mg/dL |
| Ethanol | 1% |
| Folic acid | 800µg/mL |
| Vitamin B1 | 800µg/mL |
| β-hydroxybutyrate | 2000mg/dL |
| EDTA | 80mg/dL |
| Thiophene | 20mg/dL |
| Benzoylecgonine | 10mg/dL |
| Cannabinol | 10mg/dL |
| Ephedrine | 20mg/dL |
| Phenylpropanolamine | 20mg/dL |
| Phenothiazine | 20mg/dL |
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# Effect of urine pH:
Effect of urine pH was performed by adjusting urine samples containing 0mlU/mL, 10mlU/mL and 25mlU/mL hCG urine standard to a pH range of 3.0, 3.5,4.0,4.5,5.0,5.5,6.0,6.5,7.0,7.5,8.0, 8.5, and 9.0. The results demonstrated the subject device will continue to return a correct result when tested with a urine sample in the pH range of 3.0 - 9.0.
## Effect of Urine Specific Gravity:
To test the effect of specific gravity, urine samples containing OmlU/mL, 10 mIU/mL and 25 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. Three batches of each format were tested. The results showed the subject device will continue to return a correct result in response to changes in specific gravity within the range from 1.000 - 1.035.
# High Dose Hook Effect Study
To evaluate high dose hook effect, 10 hCG-free specimens were spiked with hCG at 5,000, 10,000, 100,000, 500,000, 850,000, 850,000, 950,000 and 1,000,000 mIU/mL and were tested on three lots of devices for each format. The results demonstrated that no hook effect was observed at hCG concentration up to 1,000,000 mIU/mL.
## Effect of hCG ß-core fragment:
To evaluate the effects of the hCG ß-core fragment, normal non-pregnant women urine specimens containing 0mlU/mL,10mlU/mL and 25mlU/mL hCG were spiked with the hCG ß-core fragment at concentrations of 125,000pmol/mL, 250,000pmol/mL, 500,000pmol/mL and 1,000,000pmol/mL. Three lots of each format were tested.
The data demonstrated that there is no interference when the hCG ß-core fragment was tested at a concentration of 1,000,000 pmol/L.
# 2. Comparison Study:
a. Method comparison with predicate device
A total of 300 urine samples from females of childbearing age were collected in this clinical trial for parallel testing. Ages of these women ranged from 18 to 48 years.
Samples were collected at various time throughout the day and were
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randomized prior to testing. Testing was performed by laboratory professionals at 3 clinical study unit. Results of the professional using the candidate device were compared to results obtained from the predicate device. Summary of results are presented in the tables below:
| Candidate device | Predicate device | |
|------------------|------------------|----------|
| | Positive | Negative |
| Positive | 50 | 0 |
| Negative | 0 | 50 |
| Total | 50 | 50 |
# The results of professional method comparison (Strip)
## The results of professional method comparison (Cassette)
| Candidate device | Predicate device | |
|------------------|------------------|----------|
| | Positive | Negative |
| Positive | 50 | 0 |
| Negative | 0 | 50 |
| Total | 50 | 50 |
#### The results of professional method comparison (Midstream, in-stream method)
| Candidate device | Predicate device | |
|------------------|------------------|----------|
| | Positive | Negative |
| Positive | 50 | 0 |
| Negative | 0 | 50 |
| Total | 50 | 50 |
#### b. Matrix Comparison
Not Applicable. The device is intended for urine sample only.
## 3.Lay User Study:
300 women's individual pregnancy status was self-tested. Individuals with varying educational and occupational backgrounds were chosen for the study. 100 lay users using test strip, 100 lay users using test cassette, 100 lay users using the test midstream (in-stream method). Each subject tested her own urine sample using the device according to the package insert and the results of their test were compared to results reported by a laboratory professional using the predicate device.
Samples were also randomized prior to testing and specimens were collected throughout the day and tested.
The results are summarized in the table below.
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# Results of the lay user method comparison for the HCG Home Use Pregnancy Test Strip (Colloidal Gold)
| | Candidate device | | Predicate device -<br>Professional user | | Total |
|-----------|------------------|----------|-----------------------------------------|-----|-------|
| | | Positive | Negative | | |
| Lay users | Positive | 50 | 0 | 50 | |
| | Negative | 0 | 50 | 50 | |
| | Total | 50 | 50 | 100 | |
# Results of the lay user method comparison for the HCG Home Use Pregnancy Test Cassette (Colloidal Gold)
| Candidate device | Predicate device - Professional user | | Total |
|------------------|--------------------------------------|----------|-------|
| | Positive | Negative | |
| Lay users | | | |
| Positive | 50 | 0 | 50 |
| Negative | 0 | 50 | 50 |
| Total | 50 | 50 | 100 |
# Results of the lay user method comparison for the HCG Home Use Pregnancy Test Midstream (Colloidal Gold) (in-stream method)
| Candidate device | Predicate device -<br>Professional user | | Total | |
|------------------|-----------------------------------------|----------|-------|-----|
| | Positive | Negative | | |
| Lay users | Positive | 50 | 0 | 50 |
| | Negative | 0 | 50 | 50 |
| Total | | 50 | 50 | 100 |
# K. Conclusion
Based on the test principle and performance characteristics of the device including precision, interference, specificity, method comparison and lay-user studies of the devices, it's concluded that the subject device is substantially equivalent to the predicate.
