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K Number
K241394
Device Name
iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip
Manufacturer
Andon Health Co., Ltd.
Date Cleared
2024-12-20

(218 days)

Product Code
LCX
Regulation Number
862.1155
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 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.
More Information

K213379

Not Found

No
The device description and performance studies focus on a standard lateral flow immunoassay for detecting hCG. There is no mention of AI, ML, image processing, or any computational analysis of the test results. The result is determined by the visual presence of lines.

No.
The device is an in vitro diagnostic test used to detect the presence of hCG in urine to assess early pregnancy, not to treat or cure a disease or condition.

Yes

The device is explicitly described as an "OTC in vitro diagnostic test" for assessing early pregnancy by detecting hCG in urine. Its intended use is as an "aid in early detection of pregnancy."

No

The device description clearly states it is a "lateral flow immunoassay technique device" and details the physical components of the test strip (Sample pad, colloidal gold binding pad, nitrocellulose membrane, etc.). This indicates it is a physical in vitro diagnostic test, not a software-only device.

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

The document explicitly states in multiple sections:

  • Intended Use / Indications for Use: "The iHealth® Early Pregnancy Test is an OTC in vitro diagnostic test..." and "The iHealth® Early Pregnancy Test Strip is an OTC in vitro diagnostic test..."
  • 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."

These statements clearly identify the device as an in vitro diagnostic test.

N/A

Intended Use / Indications for 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.

Product codes

LCX

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Over-The-Counter use

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

  1. Precision/Sensitivity Study:

    • Study Type: Analytical Performance
    • Sample Size: 405 samples per hCG concentration level (0, 3, 5, 7.5, 10, 12.5, 15, 25 mIU/mL) for each lot for both Strip and Stick (dip and midstream) formats. Total 1215 tests per format per concentration for all 3 lots.
    • Data Source: Not-pregnant female urine spiked with hCG traceable to the 5th WHO international standard.
    • Key Results: The sensitivity of iHealth® Early Pregnancy Test and iHealth® Early Pregnancy Test Strip is demonstrated to be 10 mIU/mL, showing 100% positive results at and above this concentration and 0% positive results below 5 mIU/mL.

  2. Hook Effect Test:

    • Study Type: Analytical Performance
    • Sample Size: Not explicitly stated, but tested with hCG concentrations from 0 mIU/mL up to 1,000,000 mIU/mL.
    • Key Results: No hook effect was observed at hCG concentration up to 1,000,000 mIU/mL.

  3. Specificity Study to determine false-positive result rate:

    • Study Type: Analytical Performance (Specificity)
    • Sample Size: 300 urine samples (100 from premenopausal, 100 from peri-menopausal, 100 from postmenopausal women).
    • Data Source: Urine samples from normal, non-pregnant premenopausal (ages 1840 years old), peri-menopausal (4155 years old) and postmenopausal (>55 years old) women.
    • Key Results: No false positive results were observed for any of the age groups for both Strip and Stick formats (dip and midstream methods).

  4. Effect of cross reactivity:

    • Study Type: Analytical Performance (Specificity/Cross-reactivity)
    • Sample Size: Not explicitly stated, tested with negative and positive urine samples (0 and 10 mIU/mL hCG) spiked.
    • Key Results: No cross-reactivity was observed with 500 mIU/mL hLH, 1000 mIU/mL hFSH, and 1000 µIU/mL hTSH at tested concentrations.

  5. Effect of hCG ß-core fragment (hCG ß cf):

    • Study Type: Analytical Performance
    • Sample Size: Not explicitly stated, tested with negative and positive urine samples (0 and 10 mIU/mL hCG) spiked.
    • Key Results: The performance was not affected by hCG ß-core fragment concentrations up to 1,000,000 pmol/L.

  6. Interfering substance:

    • Study Type: Analytical Performance (Interference)
    • Sample Size: Not explicitly stated, tested with negative and positive urine samples (0 and 10 mIU/mL hCG) spiked with various substances.
    • Key Results: No interference effect was observed at the tested concentrations for a wide range of substances.

  7. Effect of urine pH:

    • Study Type: Analytical Performance (Interference)
    • Sample Size: Not explicitly stated, tested with negative and positive urine samples (0 and 10 mIU/mL hCG) at various pH values.
    • Key Results: pH ranging from 4.0~9.0 in urine samples does not affect the performance.

  8. Effect of urine specific gravity:

    • Study Type: Analytical Performance (Interference)
    • Sample Size: Not explicitly stated, tested with negative and positive urine samples (0 and 10 mIU/mL hCG) at various specific gravities.
    • Key Results: Urine with a relative specific gravity ranging from 1.000 to 1.035 does not affect the performance.

  9. Method comparison study:

    • Study Type: Comparison Study
    • Sample Size: 204 pregnant and non-pregnant subjects. 109 positive samples, 95 negative samples.
    • Data Source: Samples collected from pregnant and non-pregnant subjects.
    • Key Results: The conformity between the candidate device (iHealth® Early Pregnancy Test and iHealth® Early Pregnancy Test Strip) and the predicate device was 100%.

  10. Lay user study (urine samples):

    • Study Type: Lay User Study
    • Sample Size: 204 pregnant and not pregnant women subjects.
    • Data Source: Subjects' own urine samples.
    • Key Results: The lay person results showed 100% positive and 100% negative conformity with the professional results. Questionnaire reflected ease of use and understanding of labeling.

  11. Lay User Spiked Standard:

    • Study Type: Lay User Study (Spiked samples)
    • Sample Size: 100 women.
    • Data Source: Samples spiked with 0, 2, 3, 5, 10 and 15 mIU/mL hCG.
    • Key Results: Showed 100% positive detection at 10 mIU/mL hCG and above, and 0% positive detection at 3 mIU/mL hCG and below.

  12. Detection of hCG in Early Pregnancy Clinical Samples:

    • Study Type: Clinical Study
    • Sample Size: 83 subjects.
    • Data Source: Early pregnancy urine samples from day -8 to day +1 of their expected period.
    • Key Results: Demonstrated increasing pregnancy detection rates as days approached and passed the missed period, reaching 100% by day -1 relative to expected missed period for all formats.

Key Metrics

  • Sensitivity: 10 mIU/mL (100% positive agreement at or above this concentration in analytical studies).
  • Specificity: 100% (no false positives observed in 300 non-pregnant samples).
  • Conformity with Predicate Device: 100% positive agreement and 100% negative agreement.
  • Lay User Agreement with Professional Results: 100% positive agreement and 100% negative agreement.
  • Lay User Detection Rate (Spiked Samples): 100% at 10 mIU/mL and 15 mIU/mL, 0% at 0, 2, 3 mIU/mL, 46% at 5 mIU/mL (Strip format), 43% at 5 mIU/mL (Stick dip), 44% at 5 mIU/mL (Stick midstream).
  • Clinical Sample Detection Rate: From 5-6% at Day -8 to 100% at Day -1 relative to Expected Missed Period and onwards.

Predicate Device(s)

K213379

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 862.1155 Human chorionic gonadotropin (HCG) test system.

(a)
Human chorionic gonadotropin (HCG) test system intended for the early detection of pregnancy —(1)Identification. A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class II.(b)
Human chorionic gonadotropin (HCG) test system intended for any uses other than early detection of pregnancy —(1)Identification. A human chorionic goadotropin (HCG) test system is a device intended for any uses other than early detection of pregnancy (such as an aid in the diagnosis, prognosis, and management of treatment of persons with certain tumors or carcinomas) is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class III.(3)
Date PMA or notice of completion of a PDP is required. As of the enactment date of the amendments, May 28, 1976, an approval under section 515 of the act is required before the device described in paragraph (b)(1) may be commercially distributed. See § 862.3.

0

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.

1

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

2

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

3

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)
Prescription Use (Part 21 CFR 801 Subpart D)Over-The-Counter Use (21 CFR 801 Subpart C)

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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
iHealth® Early Pregnancy Test Strip
Model:IHC-3000
Common Name:Human chorionic gonadotropin (HCG) test system
510(k) NumberK241394
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
ClassificationII
  • LCX Product Code :

5

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
Predicate Device (K213379) | |
|------|----------------------------------------------|---------------------------------|
| | iHealth® Early Pregnancy Test | Clearblue® Early Pregnancy Test |

6

| | iHealth® Early Pregnancy Test
Strip | |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | Qualitative detection of human
hCG for an aid in early detection
of pregnancy. | Same |
| 'Early Test'
Claim | 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. | Same |
| Target User | Over-The-Counter use | Same |
| Sample Matrix | Urine | Same |
| Analyte | hCG | Same |
| Read Time | 3-5 minutes | Same |
| hCG
Sensitivity | 10mIU/mL | Same |
| Test Principle | Lateral flow sandwich immune
chromatographic assay with visual
result display | Same |
| Assay Mobile
Phase | Gold conjugate | Same |
| Control
Mechanism | Visual | Same |
| Results
Display | Visual Parallel Line
2 Lines = Pregnant
1 Line = Not Pregnant | Same |
| Test Type | Qualitative | Same |
| Differences | | |
| Device Format | Two formats: Strip and Stick | One format |
| Sample
application | Strip format: dip
Stick format: midstream and dip | In-stream and dip |
| Traceability | WHO 5th International Standard for
hCG | WHO 4th International Standard for
hCG |
| Analyte
Detection | Recognizes intact hCG and hCG β-
subunit | Detects intact hCG.
Scavenger system to remove
intact hCG in the presence of |

7

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
concentration

(mIU/mL)Lot 1Lot 2Lot 3Total result
Negative
(n)Positive
(n)Positive
(%)Negative
(n)Positive
(n)Positive
(%)Negative
(n)Positive
(n)Positive
(%)Negative
(n)Positive
(n)Positive
(%)
013500135001350040500
313500135001350040500
5587757.0%538260.7%597656.3%17023558.0%
7.5419469.6%439268.1%3510074.1%11928670.6%
100135100%0135100%0135100%0405100%
12.50135100%0135100%0135100%0405100%
150135100%0135100%0135100%0405100%
250135100%0135100%0135100%0405100%

iHealth® Early Pregnancy Test Strip format:

iHealth® Early Pregnancy Test Stick format (dip method)

| hCG
concentration

(mIU/mL)Lot 1Lot 2Lot 3Total result
Negative
(n)Positive
(n)Positive
(%)Negative
(n)Positive
(n)Positive
(%)Negative
(n)Positive
(n)Positive
(%)Negative
(n)Positive
(n)Positive
(%)
013500135001350040500
313500135001350040500

8

iHealth® Early Pregnancy Test FDA 510(k) Files

5627354.1%587757.0%686749.6%18821753.6%
7.5488764.4%379872.6%439268.1%12827768.4%
100135100%0135100%0135100%0405100%
12.50135100%0135100%0135100%0405100%
150135100%0135100%0135100%0405100%
250135100%0135100%0135100%0405100%

iHealth® Early Pregnancy Test Stick format (midstream method)

hCGLot 1Lot 2Lot 3Total result
concentration
( mIU/mL )Negative
(n)Positive
(n)Positive
(%)Negative
(n)Positive
(n)Positive
(%)Negative
(n)Positive
(n)Positive
(%)Negative
(n)Positive
(n)Positive
(%)
013500135001350040500
313500135001350040500
5676850.4%637253.3%666951.1%19620951.6%
7.5449167.4%488764.6%498663.7%14126465.2%
100135100%0135100%0135100%0405100%
12.50135100%0135100%0135100%0405100%
150135100%0135100%0135100%0405100%
250135100%0135100%0135100%0405100%

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 1840 years old), peri-menopausal (4155 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:

SubstancesConcentration
Acetaminophen20mg/dL
Acetoacetic Acid500mg/dL
Acetylsalicylic Acid20mg/dL
Albumin2000mg/dL
Ampicillin20mg/dL
Ascorbic Acid20mg/dL
Atropine20mg/dL
Benzoylecgonine10mg/dL

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B-hydroxybutyrate1000mg/dL
Bilirubin2mg/dL
Caffeine20mg/dL
Cannabinol10mg/dL
Codeine6μg/dL
EDTA80mg/dL
Estriol-17-beta1400μg/dL
Ethanol1.00%
Gentisic Acid20mg/dL
Glucose2000mg/dL
Hemoglobin500mg/dL
Ketone20mg/dL
Methanol10%
Phenothiazine20mg/dL
Phenylpropanolamine20mg/dL
Pregnanediol1500μg/dL
Salicylic Acid20mg/dL
Tetracycline20mg/dL
Thiophene20mg/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 DevicePositiveNegativetotal
iHealth®
Early
Pregnancy
Test StripPositive54054
Negative04949
total5449103

iHealth® Early Pregnancy Test Strip format (dip method)

iHealth® Early Pregnancy Test Stick format (dip and midstream methods)

Candidate DevicePredicate device
PositiveNegativetotal
iHealth®
Early
Pregnancy
TestPositive55055
Negative04646
total5546101

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 DeviceProfessional
PositiveNegativetotal
Lay userPositive54054
Negative04949
total5449103

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iHealth® Early Pregnancy Test Stick format (dip and midstream methods)
Lay userCandidate DeviceProfessional
PositivePositiveNegativetotal
55055
Negative04646
total5546101
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
number | hCG
concentration | Lay users Results | | % positive |
|------------------|----------------------|-----------------------|-----------------------|------------|
| | | Number of
positive | Number of
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
number | hCG
concentration | Lay users Results | | % positive |
|------------------|----------------------|-----------------------|-----------------------|------------|
| | | Number of
positive | Number of
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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D5 mIU/mL435743%
F10 mIU/mL1000100%
C15 mIU/mL1000100%

iHealth® Early Pregnancy Test Stick format (simulated midstream method)

| Sample
number | hCG
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
relative to
EMP | Day relative to
Missed Period | Percent
Pregnant
Result(%) | Number
Pregnant
Result | Number Not
Pregnant Result | Total
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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0-1100%83083
+10100%83083

| Day
relative to
EMP | Day relative to
Missed Period | Percent
Pregnant
Result(%) | Number
Pregnant
Result | Number Not
Pregnant Result | Total
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
relative to
EMP | Day relative to
Missed Period | Percent
Pregnant
Result(%) | Number
Pregnant
Result | Number Not
Pregnant Result | Total
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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