iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip
Device Facts
| Record ID | K241394 |
|---|---|
| Device Name | iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip |
| Applicant | Andon Health Co, Ltd. |
| Product Code | LCX · Clinical Chemistry |
| Decision Date | Dec 20, 2024 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1155 |
| Device Class | Class 2 |
Intended Use
The iHealth® Early Pregnancy Test is an OTC in vitro diagnostic test used to assess early pregnancy by detecting the presence of the hCG (human chorionic gonadotropin) hormone in urine. The test device is intended for use as an aid in early detection of pregnancy, in some cases as early as six (6) days before the missed period, i.e., as early as five (5) days before the day of the expected period. The iHealth® Early Pregnancy Test Strip is an OTC in vitro diagnostic test used to assess early pregnancy by detecting the presence of the hCG (human chorionic gonadotropin) hormone in urine. The test device is intended for use as an aid in early detection of pregnancy, in some cases as early as six (6) days before the missed period, i.e., as early as five (5) days before the day of the expected period.
Device Story
Lateral flow immunoassay for qualitative hCG detection in urine; utilizes colloidal gold-labeled monoclonal antibodies. Device formats include test strip (dip) and test stick (dip or midstream). User applies urine sample to device; hCG binds to gold-conjugated antibody; complex migrates to test line coated with second hCG antibody; control line confirms test validity. Results displayed visually as two lines (pregnant) or one line (not pregnant) within 3-5 minutes. Used by lay users in home setting; provides rapid pregnancy status confirmation to aid clinical decision-making.
Clinical Evidence
Clinical performance supported by a study of 830 urine samples from women aged 18-55 across days +1 to -8 relative to expected period. Lay user study (n=204) demonstrated 100% agreement between lay-user and professional results. Specificity study (n=900) across pre-, peri-, and post-menopausal cohorts showed 0% false positive rate. Analytical studies confirmed 10 mIU/mL sensitivity, no high-dose hook effect up to 1,000,000 mIU/mL, and no interference from common substances, cross-reactants (LH, FSH, TSH), pH (4.0-9.0), or specific gravity (1.000-1.035).
Technological Characteristics
Lateral flow sandwich immunochromatographic assay. Components: sample pad, colloidal gold binding pad, nitrocellulose membrane, absorbent paper, PVC board. Antibodies: hCG monoclonal antibody 1 (gold conjugate), hCG monoclonal antibody 2 (test line), goat anti-mouse IgG (control line). Qualitative visual readout. Sensitivity: 10 mIU/mL. Traceability: WHO 5th International Standard for hCG.
Indications for Use
Indicated for OTC use by individuals to assess early pregnancy by detecting hCG in urine. Intended as an aid in early pregnancy detection, potentially as early as 6 days before the missed period (5 days before the expected period).
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
- Clearblue® Early Pregnancy Test (K213379)
Related Devices
- K233624 — HCG One Step Pregnancy Test Strip OTC, HCG One Step Pregnancy Test Strip Rx, HCG One Step Pregnancy Test Midstream OTC, HCG One Step Pregnancy Test Midstream Rx · Hangzhou Aichek Medical Technology Co., Ltd. · Apr 12, 2024
Submission Summary (Full Text)
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December 20, 2024
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Andon Health Co., Ltd. Liu Yi Official Correspondent No 3. Jinping Street, Ya An Road, Nankai District Tianiin. China
Re: K241394
Trade/Device Name: iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip Regulation Number: 21 CFR 862.1155 Regulation Name: Human Chorionic Gonadotropin (HCG) Test System Regulatory Class: Class II Product Code: LCX Dated: November 15, 2024 Received: November 15, 2024
Dear Liu Yi:
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 Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
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,
Joseph A. Digitally signed by
Joseph A. Joseph A. Kotarek -S Kotarek -S Date: 2024.12.20
12:59:38 -05'00' 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) K241394
Device Name iHealth® Early Pregnancy Test iHealth® Early Pregnancy Test Strip
#### Indications for Use (Describe)
The iHealth® Early Pregnancy Test is an OTC in vitro diagnostic test used to assess early pregnancy by detecting the presence of the hCG (human chorionic gonadotropin) hormone in urine. The test device is intended for use as an aid in early detection of pregnancy, in some cases as early as six (6) days before the missed period, i.e., as early as five (5) days before the day of the expected period.
The iHealth® Early Pregnancy Test Strip is an OTC in vitro diagnostic test used to assess early pregnancy by detecting the presence of the hCG (human chorionic gonadotropin) hormone in urine. The test device is intended for use as an aid in early detection of pregnancy, in some cases as early as six (6) days before the missed period, i.e., as early as five (5) days before the day of the expected period.
| 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> |
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# 510(k) Summary
## 1. Submitter's Information
| Name: | Andon Health Co., Ltd. |
|-----------------------|--------------------------------------------------------------------------------------|
| Address: | No 3, Jinping Street, Ya An Road, Nankai District, Tianjin, P.R. China Tianjin China |
| Phone Number: | 86-22-87611660 |
| Contact: | Mr. Liu Yi |
| Email: | fda@jiuan.com |
| 2. Device Information | |
| Trade Name: | iHealth® Early Pregnancy Test<br>iHealth® Early Pregnancy Test Strip |
| Model: | IHC-3000 |
| Common Name: | Human chorionic gonadotropin (HCG) test system |
| 510(k) Number | K241394 |
| Device class: | Class II |
| Classification Name: | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Regulation Number: | 21 CFR 862.1155 |
| Product Code(s): | LCX |
| Panel: | Clinical Chemistry (75) |
| 3. Predicate Device | |
| Manufacturer: | SPD Swiss Precision Diagnostics GmbH |
| Device Name: | Clearblue® Early Pregnancy Test |
| 510(k) Number: | K213379 |
| Classification | II |
- LCX Product Code :
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### 4. Device Description
The iHealth® Early Pregnancy Test is a lateral flow immunoassay technique device designed for the qualitative determination of human chorionic gonadotropin (hCG) concentration in human urine samples, and is indicated for use as an aid in early detection of pregnancy. The iHealth® Early Pregnancy Test is designed to detect as early as six (6) days before the day of the missed period, i.e., as early as five (5) days before the day of the expected period. Test result is displayed to the user as two lines for a 'Pregnant' result and one line for a 'Not Pregnant' result.
The iHealth® Early Pregnancy Test are in two different formats: Stick and Strip format. Two test formats use identical strips and each test strip in the device consists of: Sample pad, colloidal gold binding pad, nitrocellulose membrane, absorbent paper and PVC board, colloidal gold binding pad coated with hCG monoclonal antibody 1, test line(T Line) coated with hCG-monoclonal antibody 2 and control line(C Line) coated with goat anti-mouse IgG antibody.
Two formats have the same performance specifications. The difference is that Stick format is designed to be tested in dip or midstream method, and Strip format is tested in dip method only.
### 5. Intended Use
The iHealth® Early Pregnancy Test is an OTC in vitro diagnostic test used to assess early pregnancy by detecting the presence of the hCG (human chorionic gonadotropin) hormone in urine. The test device is intended for use as an aid in early detection of pregnancy, in some cases as early as six (6) days before the day of the missed period, i.e., as early as five (5) days before the day of the expected period.
The iHealth® Early Pregnancy Test Strip is an OTC in vitro diagnostic test used to assess early pregnancy by detecting the presence of the hCG (human chorionic gonadotropin) hormone in urine. The test device is intended for use as an aid in early detection of pregnancy, in some cases as early as six (6) days before the day of the missed period, i.e., as early as five (5) days before the day of the expected period.
#### 6. Comparison to Predicate Device
The following table is the comparison summary of the proposed subject device and predicate device.
| Item | Subject Device<br>Predicate Device (K213379) | |
|------|----------------------------------------------|---------------------------------|
| | iHealth® Early Pregnancy Test | Clearblue® Early Pregnancy Test |
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| | iHealth® Early Pregnancy Test<br>Strip | |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | Qualitative detection of human<br>hCG for an aid in early detection<br>of pregnancy. | Same |
| 'Early Test'<br>Claim | The test device is intended for use as<br>an aid in early detection of<br>pregnancy, in some cases as early as<br>six (6) days before the day of the<br>missed period, i.e. as early as five (5)<br>days before the day of the expected<br>period. | Same |
| Target User | Over-The-Counter use | Same |
| Sample Matrix | Urine | Same |
| Analyte | hCG | Same |
| Read Time | 3-5 minutes | Same |
| hCG<br>Sensitivity | 10mIU/mL | Same |
| Test Principle | Lateral flow sandwich immune<br>chromatographic assay with visual<br>result display | Same |
| Assay Mobile<br>Phase | Gold conjugate | Same |
| Control<br>Mechanism | Visual | Same |
| Results<br>Display | Visual Parallel Line<br>2 Lines = Pregnant<br>1 Line = Not Pregnant | Same |
| Test Type | Qualitative | Same |
| Differences | | |
| Device Format | Two formats: Strip and Stick | One format |
| Sample<br>application | Strip format: dip<br>Stick format: midstream and dip | In-stream and dip |
| Traceability | WHO 5th International Standard for<br>hCG | WHO 4th International Standard for<br>hCG |
| Analyte<br>Detection | Recognizes intact hCG and hCG β-<br>subunit | Detects intact hCG.<br>Scavenger system to remove<br>intact hCG in the presence of |
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| | FSH. |
|--|------|
| | |
| | |
#### 7. Performance characteristics
#### A. Analytical performance
### a. Precision/Sensitivity
Not-pregnant female urine was spiked with hCG traceable to the 5th WHO international standard with hCG concentrations of 0, 3, 5, 7.5, 10, 12.5, 15 and 25mIU/mL. Each standard was tested with devices from three different lots for each format. The study was performed by nine operators over five days at three sites.
The results are summarized in the tables below:
| hCG<br>concentration<br>(mIU/mL) | Lot 1 | | | Lot 2 | | | Lot 3 | | | Total result | | |
|----------------------------------|-----------------|-----------------|-----------------|-----------------|-----------------|-----------------|-----------------|-----------------|-----------------|-----------------|-----------------|-----------------|
| | Negative<br>(n) | Positive<br>(n) | Positive<br>(%) | Negative<br>(n) | Positive<br>(n) | Positive<br>(%) | Negative<br>(n) | Positive<br>(n) | Positive<br>(%) | Negative<br>(n) | Positive<br>(n) | Positive<br>(%) |
| 0 | 135 | 0 | 0 | 135 | 0 | 0 | 135 | 0 | 0 | 405 | 0 | 0 |
| 3 | 135 | 0 | 0 | 135 | 0 | 0 | 135 | 0 | 0 | 405 | 0 | 0 |
| 5 | 58 | 77 | 57.0% | 53 | 82 | 60.7% | 59 | 76 | 56.3% | 170 | 235 | 58.0% |
| 7.5 | 41 | 94 | 69.6% | 43 | 92 | 68.1% | 35 | 100 | 74.1% | 119 | 286 | 70.6% |
| 10 | 0 | 135 | 100% | 0 | 135 | 100% | 0 | 135 | 100% | 0 | 405 | 100% |
| 12.5 | 0 | 135 | 100% | 0 | 135 | 100% | 0 | 135 | 100% | 0 | 405 | 100% |
| 15 | 0 | 135 | 100% | 0 | 135 | 100% | 0 | 135 | 100% | 0 | 405 | 100% |
| 25 | 0 | 135 | 100% | 0 | 135 | 100% | 0 | 135 | 100% | 0 | 405 | 100% |
### iHealth® Early Pregnancy Test Strip format:
iHealth® Early Pregnancy Test Stick format (dip method)
| hCG<br>concentration<br>(mIU/mL) | Lot 1 | | | Lot 2 | | | Lot 3 | | | Total result | | |
|----------------------------------|-----------------|-----------------|-----------------|-----------------|-----------------|-----------------|-----------------|-----------------|-----------------|-----------------|-----------------|-----------------|
| | Negative<br>(n) | Positive<br>(n) | Positive<br>(%) | Negative<br>(n) | Positive<br>(n) | Positive<br>(%) | Negative<br>(n) | Positive<br>(n) | Positive<br>(%) | Negative<br>(n) | Positive<br>(n) | Positive<br>(%) |
| 0 | 135 | 0 | 0 | 135 | 0 | 0 | 135 | 0 | 0 | 405 | 0 | 0 |
| 3 | 135 | 0 | 0 | 135 | 0 | 0 | 135 | 0 | 0 | 405 | 0 | 0 |
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iHealth® Early Pregnancy Test FDA 510(k) Files
| 5 | 62 | 73 | 54.1% | 58 | 77 | 57.0% | 68 | 67 | 49.6% | 188 | 217 | 53.6% |
|------|----|-----|-------|----|-----|-------|----|-----|-------|-----|-----|-------|
| 7.5 | 48 | 87 | 64.4% | 37 | 98 | 72.6% | 43 | 92 | 68.1% | 128 | 277 | 68.4% |
| 10 | 0 | 135 | 100% | 0 | 135 | 100% | 0 | 135 | 100% | 0 | 405 | 100% |
| 12.5 | 0 | 135 | 100% | 0 | 135 | 100% | 0 | 135 | 100% | 0 | 405 | 100% |
| 15 | 0 | 135 | 100% | 0 | 135 | 100% | 0 | 135 | 100% | 0 | 405 | 100% |
| 25 | 0 | 135 | 100% | 0 | 135 | 100% | 0 | 135 | 100% | 0 | 405 | 100% |
iHealth® Early Pregnancy Test Stick format (midstream method)
| hCG | Lot 1 | | | Lot 2 | | | Lot 3 | | | Total result | | |
|-----------------------------|-----------------|-----------------|-----------------|-----------------|-----------------|-----------------|-----------------|-----------------|-----------------|-----------------|-----------------|-----------------|
| concentration<br>( mIU/mL ) | Negative<br>(n) | Positive<br>(n) | Positive<br>(%) | Negative<br>(n) | Positive<br>(n) | Positive<br>(%) | Negative<br>(n) | Positive<br>(n) | Positive<br>(%) | Negative<br>(n) | Positive<br>(n) | Positive<br>(%) |
| 0 | 135 | 0 | 0 | 135 | 0 | 0 | 135 | 0 | 0 | 405 | 0 | 0 |
| 3 | 135 | 0 | 0 | 135 | 0 | 0 | 135 | 0 | 0 | 405 | 0 | 0 |
| 5 | 67 | 68 | 50.4% | 63 | 72 | 53.3% | 66 | 69 | 51.1% | 196 | 209 | 51.6% |
| 7.5 | 44 | 91 | 67.4% | 48 | 87 | 64.6% | 49 | 86 | 63.7% | 141 | 264 | 65.2% |
| 10 | 0 | 135 | 100% | 0 | 135 | 100% | 0 | 135 | 100% | 0 | 405 | 100% |
| 12.5 | 0 | 135 | 100% | 0 | 135 | 100% | 0 | 135 | 100% | 0 | 405 | 100% |
| 15 | 0 | 135 | 100% | 0 | 135 | 100% | 0 | 135 | 100% | 0 | 405 | 100% |
| 25 | 0 | 135 | 100% | 0 | 135 | 100% | 0 | 135 | 100% | 0 | 405 | 100% |
Based on the above results, the sensitivity of iHealth® Early Pregnancy Test and iHealth® Early Pregnancy Test Strip is demonstrated to be 10 mIU/mL.
#### b. Linearity/Assay measuring range
N/A. This is a qualitative detection device.
#### c. Hook effect test
Not-pregnant female urine was spiked with hCG to concentrations of 0 mIU/mL, 10mIU/mL, 1,000 mIU/mL, 10,000 mIU/mL, 100,000 mIU/mL and 1,000,000 mIU/mL. The results demonstrated that no hook effect was observed at hCG concentration up to 1,000,000 mIU/mL.
### d. Stability
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The iHealth® Early Pregnancy Test and iHealth® Early Pregnancy Test Strip have been verified for shelf-life stability for 24 months at both 36°F - 86°F (2°C - 30°C).
### e. Specificity and cross reactivity
### Specificity study to determine false-positive result rate
To evaluate specificity, 300 urine samples were collected from normal, non-pregnant premenopausal (ages 18~40 years old), peri-menopausal (41~55 years old) and postmenopausal (>55 years old). 100 people for each age group. Each urine sample was tested with iHealth® Early Pregnancy Test Strip format, iHealth® Early Pregnancy Test Stick format (dip method and midstream method). No false positive results were observed for any of the age groups.
### Effect of cross reactivity
To evaluate cross-reactivity, negative and positive urine samples (0 and 10 mIU/mL hCG) were spiked with potential cross reactants (500 mIU/mL hLH, 1000 mIU/mL hFSH, 1000 µIU/mL hTSH). No cross-reactivity was observed at tested concentration.
### Effect of hCG β -core fragment (hCG β cf)
To evaluate the effect of the hCG ß-core fragment, negative and positive urine samples (0 and 10 mIU/mL hCG) were spiked with hCG ß-core fragment at concentrations of 0 pmol/L, 250,000 pmol/L, 500,000 pmol/L and 1,000,000 pmol/L. The performance of iHealth® Early Pregnancy Test was not affected by hCG ß-core fragment concentrations up to 1,000,000 pmol/L.
### f. Interfering substance
#### Interference from exogenous and endogenous substances
To evaluate the effect of the potential interfering substance, negative and positive urine samples (0 and 10 mIU/mL hCG) were spiked with the interfering substance to obtain the certain desired test concentration. No interference effect was observed at the tested concentration shown in table below:
| Substances | Concentration |
|----------------------|---------------|
| Acetaminophen | 20mg/dL |
| Acetoacetic Acid | 500mg/dL |
| Acetylsalicylic Acid | 20mg/dL |
| Albumin | 2000mg/dL |
| Ampicillin | 20mg/dL |
| Ascorbic Acid | 20mg/dL |
| Atropine | 20mg/dL |
| Benzoylecgonine | 10mg/dL |
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| B-hydroxybutyrate | 1000mg/dL |
|---------------------|-----------|
| Bilirubin | 2mg/dL |
| Caffeine | 20mg/dL |
| Cannabinol | 10mg/dL |
| Codeine | 6μg/dL |
| EDTA | 80mg/dL |
| Estriol-17-beta | 1400μg/dL |
| Ethanol | 1.00% |
| Gentisic Acid | 20mg/dL |
| Glucose | 2000mg/dL |
| Hemoglobin | 500mg/dL |
| Ketone | 20mg/dL |
| Methanol | 10% |
| Phenothiazine | 20mg/dL |
| Phenylpropanolamine | 20mg/dL |
| Pregnanediol | 1500μg/dL |
| Salicylic Acid | 20mg/dL |
| Tetracycline | 20mg/dL |
| Thiophene | 20mg/dL |
#### Effect of urine pH
To evaluate the effect of urine pH, negative and positive urine samples (0 and 10 mIU/mL hCG) were tested at pH values of 4, 5, 6, 7, 8 and 9. The results demonstrate that pH ranging from 4.0~9.0 in urine samples does not affect the performance of iHealth® Early Pregnancy Test and iHealth® Early Pregnancy Test Strip.
#### Effect of urine specific gravity
To evaluate the effect of urine specific gravity, negative and positive urine samples (0 and 10 mIU/mL hCG) were tested at urine specific gravity of 1.000, 1.005, 1.015, 1.030 and 1.035. The results demonstrate that urine with a relative specific gravity ranging from 1.000 to 1.035 does not affect the performance of iHealth® Early Pregnancy Test and iHealth® Early Pregnancy Test Strip.
#### B. Comparison study
#### a. Method comparison study
The performance of the new device was compared to the predicate device. A total of 204 pregnant and non-pregnant subjects collected samples and completed the study to obtain
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a valid result. 109 were positive samples and 95 were negative samples. All samples were tested with candidate and predicate devices by professionals.
The results are summarized in the table below:
| Predicate device | | | | |
|----------------------------------------------|----------|----------|-------|-----|
| Candidate Device | Positive | Negative | total | |
| iHealth®<br>Early<br>Pregnancy<br>Test Strip | Positive | 54 | 0 | 54 |
| | Negative | 0 | 49 | 49 |
| | total | 54 | 49 | 103 |
iHealth® Early Pregnancy Test Strip format (dip method)
#### iHealth® Early Pregnancy Test Stick format (dip and midstream methods)
| Candidate Device | | Predicate device | | |
|----------------------------------------|----------|------------------|----------|-------|
| | | Positive | Negative | total |
| iHealth®<br>Early<br>Pregnancy<br>Test | Positive | 55 | 0 | 55 |
| | Negative | 0 | 46 | 46 |
| | total | 55 | 46 | 101 |
The conformity between the candidate device (iHealth® Early Pregnancy Test and iHealth® Early Pregnancy Test Strip) and the predicate device is 100%.
#### b. Lay user study
#### Lay User Study
A total of 204 pregnant and not pregnant women subjects with diverse educational and professional backgrounds and ages between 18 and 55 years old participated in the Lay User Study. Each subject tested her own urine sample using iHealth® Early Pregnancy Test and iHealth® Early Pregnancy Test Strip according to the labeling and provided a sample for professional testing.
The results are summarized in the table below:
#### iHealth® Early Pregnancy Test Strip format (dip method)
| Candidate Device | | Professional | | |
|------------------|----------|--------------|----------|-------|
| | | Positive | Negative | total |
| Lay user | Positive | 54 | 0 | 54 |
| | Negative | 0 | 49 | 49 |
| | total | 54 | 49 | 103 |
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| iHealth® Early Pregnancy Test Stick format (dip and midstream methods) | | | | |
|------------------------------------------------------------------------|------------------|--------------|----------|-------|
| Lay user | Candidate Device | Professional | | |
| | Positive | Positive | Negative | total |
| | 55 | 0 | 55 | |
| Negative | 0 | 46 | 46 | |
| total | 55 | 46 | 101 | |
| iHealth® Early Pregnancy Test Stick format (dip and midstream methods) |
|------------------------------------------------------------------------|
| |
From the above tables, the lay person results showed 100% positive and 100% negative conformity with the professional results.
Each lay user was given a questionnaire to assess the comprehensibility of the labeling. The results of the questionnaire reflected that the consumers found the test easy to use and that they did not have trouble understanding the labeling and interpreting the results.
### Lay User Spiked Standard
The second lay user study was conducted with a total of 100 women with diverse educational and professional backgrounds between the ages of 18 years to 55. Lay users performed the testing using samples spiked with 0, 2, 3, 5, 10 and 15 mIU/mL hCG using iHealth® Early Pregnancy Test and iHealth® Early Pregnancy Test Strip. Results were summarized below.
| Sample<br>number | hCG<br>concentration | Lay users Results | | % positive |
|------------------|----------------------|-----------------------|-----------------------|------------|
| | | Number of<br>positive | Number of<br>negative | |
| B | 0 mIU/mL | 0 | 100 | 0% |
| A | 2 mIU/mL | 0 | 100 | 0% |
| E | 3 mIU/mL | 0 | 100 | 0% |
| D | 5 mIU/mL | 46 | 54 | 46% |
| F | 10 mIU/mL | 100 | 0 | 100% |
| C | 15 mIU/mL | 100 | 0 | 100% |
iHealth® Early Pregnancy Test Strip format
| iHealth® Early Pregnancy Test Stick format (dip method) | | | |
|---------------------------------------------------------|--|--|--|
| | | | |
| Sample<br>number | hCG<br>concentration | Lay users Results | | % positive |
|------------------|----------------------|-----------------------|-----------------------|------------|
| | | Number of<br>positive | Number of<br>negative | |
| B | 0 mIU/mL | 0 | 100 | 0% |
| A | 2 mIU/mL | 0 | 100 | 0% |
| E | 3 mIU/mL | 0 | 100 | 0% |
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| D | 5 mIU/mL | 43 | 57 | 43% |
|---|-----------|-----|----|------|
| F | 10 mIU/mL | 100 | 0 | 100% |
| C | 15 mIU/mL | 100 | 0 | 100% |
iHealth® Early Pregnancy Test Stick format (simulated midstream method)
| Sample<br>number | hCG<br>concentration | Lay users Results | | % positive |
|------------------|----------------------|-------------------|-----|------------|
| B | 0 mIU/mL | 0 | 100 | 0% |
| A | 2 mIU/mL | 0 | 100 | 0% |
| E | 3 mIU/mL | 0 | 100 | 0% |
| D | 5 mIU/mL | 44 | 56 | 44% |
| F | 10 mIU/mL | 100 | 0 | 100% |
| C | 15 mIU/mL | 100 | 0 | 100% |
#### C. Other clinical study
#### Detection of hCG in Early Pregnancy Clinical Samples
Early pregnancy urine samples from day -8 to day +1 of their expected period were collected. The early pregnancy urine samples of each day from 83 subjects were tested using iHealth® Early Pregnancy Test Strip format and iHealth® Early Pregnancy Test Stick format (dip method and midstream method).
The results are summarized in the table below:
| Day<br>relative to<br>EMP | Day relative to<br>Missed Period | Percent<br>Pregnant<br>Result(%) | Number<br>Pregnant<br>Result | Number Not<br>Pregnant Result | Total<br>Samples |
|---------------------------|----------------------------------|----------------------------------|------------------------------|-------------------------------|------------------|
| -8 | -9 | 5% | 4 | 79 | 83 |
| -7 | -8 | 13% | 11 | 72 | 83 |
| -6 | -7 | 28% | 23 | 60 | 83 |
| -5 | -6 | 78% | 65 | 18 | 83 |
| -4 | -5 | 93% | 77 | 6 | 83 |
| -3 | -4 | 99% | 82 | 1 | 83 |
| -2 | -3 | 99% | 82 | 1 | 83 |
| -1 | -2 | 100% | 83 | 0 | 83 |
iHealth® Early Pregnancy Test Strip format
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| 0 | -1 | 100% | 83 | 0 | 83 |
|----|----|------|----|---|----|
| +1 | 0 | 100% | 83 | 0 | 83 |
| Day<br>relative to<br>EMP | Day relative to<br>Missed Period | Percent<br>Pregnant<br>Result(%) | Number<br>Pregnant<br>Result | Number Not<br>Pregnant Result | Total<br>Samples |
|---------------------------|----------------------------------|----------------------------------|------------------------------|-------------------------------|------------------|
| -8 | -9 | 5% | 4 | 79 | 83 |
| -7 | -8 | 12% | 10 | 73 | 83 |
| -6 | -7 | 27% | 22 | 61 | 83 |
| -5 | -6 | 78% | 65 | 18 | 83 |
| -4 | -5 | 93% | 77 | 6 | 83 |
| -3 | -4 | 99% | 82 | 1 | 83 |
| -2 | -3 | 99% | 82 | 1 | 83 |
| -1 | -2 | 100% | 83 | 0 | 83 |
| 0 | -1 | 100% | 83 | 0 | 83 |
| +1 | 0 | 100% | 83 | 0 | 83 |
### iHealth® Early Pregnancy Test Stick format (dip method)
#### iHealth® Early Pregnancy Test Stick format (midstream method)
| Day<br>relative to<br>EMP | Day relative to<br>Missed Period | Percent<br>Pregnant<br>Result(%) | Number<br>Pregnant<br>Result | Number Not<br>Pregnant Result | Total<br>Samples |
|---------------------------|----------------------------------|----------------------------------|------------------------------|-------------------------------|------------------|
| -8 | -9 | 6% | 5 | 78 | 83 |
| -7 | -8 | 13% | 11 | 72 | 83 |
| -6 | -7 | 27% | 22 | 61 | 83 |
| -5 | -6 | 78% | 65 | 18 | 83 |
| -4 | -5 | 93% | 77 | 6 | 83 |
| -3 | -4 | 99% | 82 | 1 | 83 |
| -2 | -3 | 99% | 82 | 1 | 83 |
| -1 | -2 | 100% | 83 | 0 | 83 |
| 0 | -1 | 100% | 83 | 0 | 83 |
| +1 | 0 | 100% | 83 | 0 | 83 |
#### 8. Conclusion
Based on the test principle and performance characteristics of the device, it's concluded that iHealth® Early Pregnancy Test and iHealth® Early Pregnancy Test Strip are substantially equivalent to the predicate device.
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