David Home Pregnancy Test Cassette is an in-vitro diagnostic test for the qualitative determination of human chorionic gonadotropin (HCG) in the urine to aid in early detection of pregnancy, based on lateral flow immunoassay. It is intended for the Over-the-Counter Use only.

David Professional Pregnancy Test Cassette is an in-vitro diagnostic test for the qualitative determination of human chorionic gonadotropin (HCG) in the urine to aid in early detection of pregnancy, based on lateral flow immunoassay. It is intended for prescription use only.

Device Description

David Pregnancy Test Cassette will be designed in one format:Cassette.The Cassette kit consists of one test device, a disposable plastic dropper, and a package insert. Each test strip contains mouse monoclonal anti-a-hCG antibody coated membrane and a pad containing mouse monoclonal anti-ß-hCG antibody colloidal gold conjugate. The control antibodies are goat anti-mouse IgG polyclonal antibody.

AI/ML Overview

The provided document describes the performance characteristics and studies for the "David Home Pregnancy Test Cassette" and "David Professional Pregnancy Test Cassette".

Here's an analysis of the acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

| Acceptance Criteria Category | Specific Criteria | Reported Device Performance and Results |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sensitivity (Detection Limit) | The positive ratio of samples containing concentrations higher than 25 mIU/mL HCG should be more than 95%. | 100% positive ratio for samples with 25 mIU/mL HCG and above (for both professional and home use, detected by both professional and lay users). At 22.5 mIU/mL HCG, positive ratios were 50% (professional), 56% (home by professional), and 45% (home by lay user). The minimum detection limit is stated as 25 mIU/mL HCG. |
| Specificity (Cross-reactivity) | No cross-reaction with LH, FSH, and TSH at specified high concentrations. | No cross-reaction observed with LH at 500 mIU/mL, FSH at 1000 mIU/mL, and TSH at 1000 μIU/mL for both 0 mIU/mL HCG and 25 mIU/mL HCG spiked samples across 3 lots. |
| Interference | No interference from various exogenous compounds at specified concentrations. | No interference observed from a list of substances (e.g., Glucose, Albumin, Bilirubin, Hemoglobin, Acetaminophen, Aspirin, etc.) at their tested concentrations, in both negative and 25 mIU/mL HCG positive samples. |
| pH Interference | No interference across a specified pH range. | pH ranging from 3 to 10 in urine samples does not interfere with the performance of the test in negative and 25 mIU/mL HCG positive samples. |
| Specific Gravity Interference | No interference across a specified specific gravity range. | Specific gravity ranging from 1.000 to 1.050 in urine samples does not interfere with the performance of the test in negative and positive urine. |
| High Dose Hook Effect | No high dosage hook effect up to a very high HCG concentration. | No hook effect observed up to 2,000,000 mIU/mL hCG. |
| hCG ß-core fragment effects | No interference from high levels of beta core fragment. | No hook effect observed at an hCG ß-core fragment concentration up to 100,000 pmol/L. |
| Precision/Reproducibility | Good repeatability between lots and within lot. For concentrations higher than 25 mIU/mL HCG, all results should be positive. For concentrations below 20 mIU/mL HCG, 98% results should be negative. | For HCG concentrations 25 mIU/mL and above, 100% positive results were obtained across all 3 lots (150/150 for each lot). For HCG concentrations 16 mIU/mL and below, 100% negative results were obtained (150/150 for each lot). At 18.75 mIU/mL, 1/150 positive results were observed across all 3 lots. At 20 mIU/mL, 5/150, 3/150, and 2/150 positive results were observed across lots 1, 2, and 3 respectively, meaning >97% negative results. The study concluded good repeatability. |
| Method Comparison (Professional vs. Predicate) | 100% agreement between the candidate device (Professional) and the predicate device. | Positive, Negative, and Total coincidence rates were all 100% (153 positive, 207 negative, total 360 samples). |
| Method Comparison (Home vs. Predicate) | 100% agreement between the candidate device (Home) and the predicate device. | Positive, Negative, and Total coincidence rates were all 100% (153 positive, 207 negative, total 360 samples). |
| Lay-user Concordance | High concordance between lay-user results and professional results for the Home Pregnancy Test Cassette. Lay users find the test easy to use and understand instructions/labeling. | Positive, Negative, and Total coincidence rates between non-professionals and professionals were all 100% (153 positive, 207 negative, total 360 samples). Lay-user study with spiked samples showed 100% positive for 27.5 mIU/mL HCG and 99% negative for 20 mIU/mL HCG. Questionnaire results indicated lay-users found the test easy to use and understood labeling. Flesch-Kincaid showed readability for 8th-grade education. |

2. Sample Size Used for the Test Set and Data Provenance

Precision/Reproducibility Study Test Set:
- Sample Size: For each HCG concentration level (0, 16, 18.75, 20, 25, 27.5, 100 mIU/mL), 150 tests were performed per lot, across 3 lots. Total tests per concentration = 150 * 3 = 450. Total tests in this study = 7 concentrations * 450 tests/concentration = 3150 tests.
- Data Provenance: Samples were urine spiked with HCG. The study was conducted at three (3) sites. The country of origin is not explicitly stated for the samples themselves but the applicant is from China. It is a prospective study (samples were used in the study, implying prepared for the study).
Detection Limit Study Test Set:
- Sample Size: For each HCG concentration level (0, 12.5, 16, 18.75, 20, 22.5, 25, 27.5, 50, 100 mIU/mL), 90 tests were performed at each of the 3 test sites (total 270 tests per concentration). Each 90 tests at a site comprised:
  - Professional Test Kit: 30 tests by professionals
  - Home Use Test Kit (by professionals): 30 tests by professionals
  - Home Use Test Kit (by lay users): 30 tests by lay users
- Data Provenance: Samples were urine spiked with HCG. The study was conducted at three (3) sites. Prospective nature, similar to the precision study.
Analytical Specificity (Cross-reactivity) Test Set:
- Sample Size: 20 fresh urine specimens (10 healthy non-pregnant women, 10 healthy men) were used for each hormone concentration (LH, FSH, TSH) spiked into negative (0 mIU/mL HCG) and positive (25 mIU/ml HCG) samples. This was done for 3 lots.
- Data Provenance: Urine specimens from healthy non-pregnant women and men. Prospective.
Interference Study Test Set:
- Sample Size: Not explicitly stated, but "Negative and positive hCG urine samples (25 mIU/mL) were individually spiked with the substances listed... Three devices of each format were tested."
- Data Provenance: Urine samples spiked with HCG and interfering substances. Prospective.
pH Interference Study Test Set:
- Sample Size: Not explicitly stated, but "Negative and positive hCG urine samples (25 mIU/mL) were tested across a pH range of 3-10."
- Data Provenance: Urine samples pH adjusted and spiked with or without HCG. Prospective.
Specific Gravity Interference Study Test Set:
- Sample Size: Not explicitly stated, but "The device was challenged with negative urine and positive urine with specific gravity from 1.000 to 1.050."
- Data Provenance: Urine samples with adjusted specific gravity and spiked with or without HCG. Prospective.
High Dose Hook Effect Study Test Set:
- Sample Size: Not explicitly stated, but "Negative urine specimens were spiked with high hCG concentration of ranging from 50 mIU/mL to 2000,000 mIU/mL. All samples yielded the expected positive results."
- Data Provenance: Urine samples spiked with high HCG concentrations. Prospective.
Effects of hCG ß-core fragment Test Set:
- Sample Size: Not explicitly stated how many actual urine samples, but "Negative urine hCG (containing 0 mIU/mL hCG,16mIU/mL HCG) and positive urine samples (containing 27.5 mIU/mL hCG) were spiked with hCG beta core fragment standard... Samples of each concentration were tested 10 times with the professional and lay-user respectively." (total 20 tests per concentration per lot, across 3 lots)
- Data Provenance: Urine samples spiked with HCG and beta-core fragment. Prospective.
Method Comparison Study Test Set:
- Sample Size: 360 fresh women urine samples.
- Data Provenance: "fresh women urine samples". Country of origin not specified, but likely from China given the applicant. This seems to be a prospective collection or at least fresh samples used in a current study.
Lay-user Study Test Set:
- Sample Size: 120 female volunteers (40 from each of three sites) for their own urine samples. Additionally, each volunteer tested 3 other double-blind numbered samples spiked with HCG (concentrations not specified but one example given is 27.5mIU/mL and 20mIU/mL HCG). This implies 120 * 3 = 360 spiked tests.
- Data Provenance: "fresh women urine samples" and urine samples spiked with HCG. Prospective, involving human volunteers.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

The document does not explicitly state the number or qualifications of "experts" used to establish the ground truth in the traditional sense of medical image interpretation or pathology review.

For analytical performance studies (Precision, Detection Limit, Specificity, Interference, etc.), the "ground truth" for HCG concentration is established by the known concentrations of spiked HCG in the urine samples, traceable to the WHO International Standard.
For the Method Comparison Study, the "ground truth" is the result from the predicate device (Wondfo One Step HCG Urine Pregnancy Test, K043443) when tested by professionals. The results from the candidate device (both professional and home use) were compared against this predicate result.
In the Precision/Reproducibility and Detection Limit studies, "9 operators" and "3 operators" (plus 30 volunteers for detection limit) were involved. Their qualifications are not specified beyond being "operators" or "professionals".
For the Lay-user study, the ground truth for the volunteers' own samples would be their actual pregnancy status (which would likely be confirmed by clinical methods or laboratory testing, though not specified as such in this document). For the spiked samples, the ground truth is the known spiked HCG concentration.

Therefore, for the analytical studies, the ground truth is based on known sample characteristics. For the method comparison, it's based on a predicate device's performance handled by "professionals". "Experts" with specific qualifications (e.g., radiologists) are not applicable to this type of in-vitro diagnostic device.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are typically used in studies where human readers independently interpret images or clinical data, and then discrepancies are resolved. This is not directly applicable to a lateral flow immunoassay pregnancy test, which provides a qualitative "positive" or "negative" result based on visual lines.

For the Precision/Reproducibility and Detection Limit studies: The results are reported as positive or negative counts across multiple tests. There's no mention of an adjudication process to resolve differing readings on the same test, suggesting direct reading of the test results.
For the Method Comparison Study: The comparison is directly between the result of the candidate device and the predicate device. If there were discrepancies, the document does not describe a formal adjudication process; instead, it reports a 100% agreement, implying no discrepancies or that any were resolved instantly during the testing by professionals.
For the Lay-user study: Lay users conducted the test according to instructions. The results from their tests were then compared to reference (likely professional reading of their own samples and known HCG content of spiked samples). No formal "adjudication" in the sense of a third-party expert review of conflicted readings is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

An MRMC comparative effectiveness study is not applicable to this device. This device is an in-vitro diagnostic test for HCG, not an AI-assisted diagnostic imaging device that involves interpretation by human readers. Therefore, there is no AI component or human reader improvement with AI to report effect sizes for.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

This question is not applicable. The device is a lateral flow immunoassay. Its "performance" is determined by the biochemical reaction on the strip and the visual interpretation of lines, which is inherently a "human-in-the-loop" visual interpretation (even for the "home use" version). There is no "algorithm only" component.

7. The Type of Ground Truth Used

For analytical performance studies (Precision, Detection Limit, Specificity, Interference, Hook Effect, Beta-core fragment): The ground truth was based on known concentrations of HCG or other substances spiked into urine samples, traceable to the WHO International Standard (5th WHO Chorionic Gonadotrophin, NIBSC code: 07/364).
For the Method Comparison Study: The ground truth was established by the results from a legally marketed predicate device (Wondfo One Step HCG Urine Pregnancy Test) when tested by professionals.
For the Lay-user study: The ground truth for volunteer's own samples would implicitly be their actual clinical pregnancy status, but this isn't detailed. For the spiked samples used in the lay-user study, the ground truth was the known spiked HCG concentration.

8. The Sample Size for the Training Set

The document describes performance studies for device validation. It does not mention any "training set" in the context of an algorithm or AI model development. This is an IVD device, not a machine learning algorithm.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" for an algorithm.

Summary

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

March 28, 2018

Runbio BioTech Co.,Ltd Chandler Chen OA Manager Rongsheng Technology Garden, Shantou University Road Shantou, Guangdong 515063, China

Re: K172627

Trade/Device Name: David Home Pregnancy Test Cassette David Professional Pregnancy Test Cassette Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: LCX, JHI Dated: February 9, 2018 Received: February 12, 2018

Dear Chandler Chen:

We have reviewed vour Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976. the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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.

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

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801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerelv.

Kellie B. Kelm -S

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

Enclosure

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Indications for Use

510(k) Number (if known) K172627

Device Name David Home Pregnancy Test Cassette

Indications for Use (Describe)

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)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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

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

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Indications for Use

510(k) Number (if known) K172627

Device Name

David Professional Pregnancy Test Cassette

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(k) SUMMARY

This summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

The Assigned 510(k) number is K172627. DATE of Summary: March 01, 2018

A. Applicant Information

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

SHANTOU, GUANGDONG,CHINA 515063

1. Telephone No.: 86-754-82528311
1. Fax: 86-754-82537111

B. Contact Information

1. Contact Person : Chandler Chen
1. Company Name: RUNBIO BIOTECH CO.,LTD
1. Address: RONGSHENG TECHNOLOGICAL ZONE, UNIVERSITY ROAD

SHANTOU , GUANGDONG,CHINA 515063

1. Telephone No.: 86-754-82537812
5.Fax No.: 86-754-82537111
6.E-mail Address:runiroad@126.com

Proprietary and Established Names ﻥ

David Home Pregnancy Test Cassette

David Professional Pregnancy Test Cassette

D.Regulatory Information

1.Regulation section:

21 CFR 862.1155 Human Chorionic Gonadotropin (HCG) test system

2.Classification:

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Class II

3.Product Code:

LCX, kit, test, pregnancy, hCG, over the counter JHI, visual, pregnancy hCG, prescription use

4. Classification Panel:

Clinical Chemistry (75)

Intended Use/Indication(s) for use Indications for use:

2.Special conditions for use statement(s):

David Home Pregnancy Test Cassette is for the Over-the-Counter only. David Professional Pregnancy Test Cassette is for the prescription use only.

E.Device Description:

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membrane and a pad containing mouse monoclonal anti-ß-hCG antibody colloidal gold conjugate. The control antibodies are goat anti-mouse IgG polyclonal antibody.

F. Substantial Equivalence Information

1.Predicate Device Name(s):

Wondfo One Step HCG Urine Pregnancy Test

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

K043443

3.Comparison with predicate

Similarities and Differences
Item	Predicate device	Candidate device
Device	Wondfo One Step HCG Urine Pregnancy Test	David Home Pregnancy TestDavid Professional Pregnancy Test
Format	Strip,Cassette and midstream	CassetteCassette
Intended Use	Qualitative detection of Human Chorionic Gonadotrophine ( hCG ) in urine to aid in the detection of pregnancy hormone	SameSame
Test Principle	Sandwich Immunochromatographic Assay	SameSame
Methodology	Colloidal Gold Immunoassay (Membrane particle assay)	samesame
Test Line	Mouse monoclonal anti-α hCG antibodies	SameSame
Detection Antibody	Mouse monoclonal anti-β hCG antibodies	SameSame
Intended User	Prescription use (strip and cassette) and OTC use (strip, cassette and midstream)	OTC use (cassette )Prescription use (cassette)
Device format	strip, cassette and midstream	cassettecassette
Sample Matrix	Human urine	samesame
Target Population	Pregnant women	SameSame
Sterility	Non-sterile	SameSame
Sensitivity	25mIU/mL	SameSame
Specificity	LH at 300 mIU/mL, FSH at 300 mIU/mL, and TSH at 1000 mIU/mL	LH at 500 mIU/mL, FSH at 1000 mIU/mL, and TSH at 1000 μIU/mLLH at 500 mIU/mL, FSH at 1000 mIU/mL, and TSH at 1000 μIU/mL
pH Interference	No interference for urine with pH 4-9	No interference for urine with pH 3-10No interference for urine with pH 3-10
Specific Gravity Interference	No interference for urine with Specific Gravity 1.000-1.050	SameSame

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HighDosageHook effect	No high dosage hook effect for hCG upto 100,000 mIU/mL	No high dosage hook effect forhCG up to2000,000 mIU/mL	No high dosage hook effect forhCG up to2000,000 mIU/mL
StorageTemperature	4 to 30°C	2 to 30 °C	2 to 30 °C
Read time	3 to 5 Minutes	5 to 15 Minutes	5 to 15 Minutes
Traceability	WHO 3rd International Standard	WHOInternationalStandard 5th WHOChorionicGonadotrophin( NIBSC code:07/364)	WHOInternationalStandard 5th WHOChorionicGonadotrophin( NIBSC code:07/364)

G. Test Principle:

a qualitative, solid phase, double antibodies sandwich The test is immunochromatographic assay. Each test device contains mouse monoclonal anti-ßhCG antibody colloidal gold conjugate pre-dried on a pad. Mouse monoclonal antiα-hCG antibody (on the Test Line) and goat anti-mouse IgG polyclonal antibody (on the Control Line) are coated and immobilized on a nitrocellulose membrane.

For the cassette device, the sample is pipette onto the sample well.

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

J. Performance Characteristics:

1. Analytical performance

a. Precision/Reproducibility

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The study was conducted in three (3) sites by a total of 9 operators with 3 lots of proposed device over 5 non-consecutive days. The samples were used with hCG spiked at the concentrations of 0, 16, 18.75, 20, 25, 27.5 and 100mIU/mL in urine. The result demonstrated that all the test results of samples with the HCG concentration higher than 25 mIU/mL are positive, and 98% of the test results of samples with the HCG concentration lower than 20 mIU/mL are negative. The colour of test line should keep consistant for each concentration sample.

According to the consistency of test results of the same sample, it can also be determined that the reagent has good repeatability between lots and within lot.

Test Concentration	Lot No.: 1		Lot No.:2		Lot No.:3
	Positive	Negative	Positive	Negative	Positive	Negative
HCG0mIU/mL	+/+(0/150)	-/-(150/150)	+/+(0/150)	-/-(150/150)	+/+(0/150)	-/-(150/150)
HCG16mIU/mL	+/+(0/150)	-/-(150/150)	+/+(0/150)	-/-(150/150)	+/+(0/150)	-/-(150/150)
HCG18.75mIU/mL	+/+(1/150)	-/-(149/150)	+/+(1/150)	-/-(149/150)	+/+(1/150)	-/-(149/150)
HCG 20mIU/mL	+/+(5/150)	-/-(145/150)	+/+(3/150)	-/-(147/150)	+/+(2/150)	-/-(148/150)
HCG 25mIU/mL	+/+(150/150)	-/-(0/150)	+/+(150/150)	-/-(0/150)	+/+(150/150)	-/-(0/150)
HCG 27.5mIU/mL	+/+(150/150)	-/-(0/150)	+/+(150/150)	-/-(0/150)	+/+(150/150)	-/-(0/150)
HCG 100mIU/mL	+/+(150/150)	-/-(0/150)	+/+(150/150)	-/-(0/150)	+/+(150/150)	-/-(0/150)

Statistical table of repeatability test results of different lots

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

Traceability:

The test is calibrated against the WHO International Standard 5th WHO Chorionic Gonadotrophin ( NIBSC code: 07/364 )

Stability:

The applicant claims a 24-month shelf life for the test when stored at 36-86 F (2-30 ℃).

Expected values :

1. Negative results are expected in healthy non-pregnant women

The amount of hCG will vary greatly with gestational age and between individuals.

c. Detection limit:

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The study was conducted in three (3) sites by a total of 3 operators and by 30 volunteers with 3 lots of proposed device over 5 non-consecutive days. The samples were used with hCG spiked at the concentrations of 0, 12.5, 16, 18.75, 20, 22.5, 25, 27.5, 50 and 100mIU/mL in urine.

Each concentration was detected for 90 times totally in each test sites, 60 times by professionals using professional test kit and Home use test kit for either 30 times respectively, and 30 times by lay users in total. The comprehensive test result statistics demonstrated that the positive ratio of samples containing more than 25 mIU/mL HCG are more than 95%, so the minimum detection limit of the reagent is HCG 25 mIU/mL; about 50% of the test results of samples containing 22.5 mIU/mL HCG are positive.

	Professional User				Lay User
Test Concentration	David ProfessionalPregnancy TestCassette		David Home Pregnancy TestCassette		David Home PregnancyTest Cassette
	Positive	PositiveRatio	Positive	PositiveRatio	Positive	PositiveRatio
HCG0mIU/mL	+/+(0/90)	0%	+/+(0/90)	0%	+/+(0/90)	0%
HCG 12.5mIU/mL	+/+(0/90)	0%	+/+(0/90)	0%	+/+(0/90)	0%
HCG 16mIU/mL	+/+(0/90)	0%	+/+(0/90)	0%	+/+(0/90)	0%
HCG 18.75mIU/mL	+/+(1/90)	1.1%	+/+(2/90)	2.2%	+/+(1/90)	1.1%
HCG 20mIU/mL	+/+(6/90)	6%	+/+(7/90)	7%	+/+(3/90)	6%
HCG 22.5mIU/mL	+/+(45/90)	50%	+/+(51/90)	56%	+/+(40/90)	45%
HCG 25mIU/mL	+/+(90/90)	100%	+/+(90/90)	100%	+/+(90/90)	100%
HCG 27.5mIU/mL	+/+(90/90)	100%	+/+(90/90)	100%	+/+(90/90)	100%
HCG 50mIU/mL	+/+(90/90)	100%	+/+(90/90)	100%	+/+(90/90)	100%
HCG 100mIU/mL	+/+(90/90)	100%	+/+(90/90)	100%	+/+(90/90)	100%

Table: Summary of Test Results

d. Analytical specificity:

Cross reactivity:

To evaluate cross-reactivity, 20 fresh urine specimens obtained from 10 healthy non-pregnant women and 10 healthy men were spiked with different

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concentrations of Lutenizing Hormone (LH), Follicle stimulating Hormone (FSH), and thyroid stimulating hormone (TSH) into negative (0 mIU/mL) and positive (25mIU/ml) samples. The results demonstrated no cross reaction with LH at 500mIU/ml, FSH at 1000 mIU/mL, and TSH at 1000μIU/mL. Results are tabulated below.

HCGconcentration	Homologoushormone concentration	LOT NO.
		20120901	20120902	20120903
HCG 0mIU/mL	LH 500mIU/mL	-/- (20/20)	-/- (20/20)	-/- (20/20)
	FSH 1000mIU/mL	-/- (20/20)	-/- (20/20)	-/- (20/20)
	TSH 1000 $ \mu $ IU/mL	-/- (20/20)	-/- (20/20)	-/- (20/20)
HCG 25mIU/mL	LH 500mIU/mL	+/+ (20/20)	+/+ (20/20)	+/+ (20/20)
	FSH 1000mIU/mL	+/+ (20/20)	+/+ (20/20)	+/+ (20/20)
	TSH 1000 $ \mu $ IU/mL	+/+ (20/20)	+/+ (20/20)	+/+ (20/20)

Table: test results of Specificity

Interference:

A study was conducted to evaluate interference of specific exogenous compounds. Negative and positive hCG urine samples (25 mIU/mL) were individually spiked with the substances listed in the table below. Three devices of each format were tested. No interference was observed from the compounds at the concentrations listed below.

	Table: Interfering Substance
--	------------------------------	--

Substance	Concentration	Substance	Concentration
Glucose	2g/dL	Acetaminophen	20 mg/dL
Albumin	2g/dL	Atropine	20 mg/dL
protein	2g/dL	Aspirin	20 mg/dL
Bilirubin	2mg/dL	Ascorbic Acid	20 mg/dL
Hemoglobin	1mg/dL	Ampicillin	20mg/dL
Vitamins C	20 mg/dL	Salicyclic Acid	20 mg/dL
Caffeine	20 mg/dL	Phenothiazine	20 mg/dL
Gentisate	20 mg/dL	Thiophene	20 mg/dL
Gentisic Acid	20 mg/dL	Ephedrine	20mg/dL
Tetracycline	20mg/dL	Ethanol	1%
Acetylsalicylic Acid	20 mg/dL	Phenylpropanolamine	20 mg/dL

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Effects of urine pH:

A study was conducted to evaluate the effect of pH. Negative and positive hCG urine samples (25 mIU/mL) were tested across a pH range of 3-10. The results demonstrate that pH ranging from 3 to 10 in urine samples does not interfere with the performance of the test.

Specific Gravity:

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

High dose hook effect study:

The test was evaluated for high dose hook effect. Negative urine specimens were spiked with high hCG concentration of of ranging from 50 mIU/mL to 2000,000 mIU/mL.All samples yielded the expected positive results. This study demonstrates that this device shows no hook effect up to 2,000,000 mIU/mL hCG.

Effects of hCG ß-core fragment:

Interference testing was performed to evaluate whether high levels of beta core fragment interfere with the device. Negative urine hCG (containing 0 mIU/mL hCG,16mIU/mL HCG) and positive urine samples (containing 27.5 mIU/mL hCG) were spiked with hCG beta core fragment standard (traceable to WHO reference reagent 99/708) at several different concentrations up to 1,000,000 pmol/L. The samples were tested using 3 different lots. Samples of each concentration were tested 10 times with the professional and lay-user respectively. However, the results demonstrated that no hook effect was observed at an hCG ß-core fragment concentration up to 100,000 pmol/L.

2. Comparison Study:

a. Method comparison with predicate device:

Totally 360 fresh women urine samples were tested at 3 sites. According to synchronous test results by the predicate device and candidate device by professionals, there were153 positive samples and 207 negative samples and all the test

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results were the same as expected. The test results obtained by the lay-users and by the professionals with predicate device were exactly the same, which means the total agreement rate was 100%.

All lay users tested their own urine by themselves with David Home Pregnancy Test Cassette according to the instructions for use in English.

Table: statistic analysis of data (professionals)

		Predicate Device
		Wondfo One Step HCG Urine Test
		Positive	Negative	total
Proposed DeviceDavid ProfessionalPregnancy Test Cassette	Positive	(a)153	(b)0	(a+b)153
	Negative	(c)0	(d)207	(c+d)207
	total	(a+c)153	(b+d)207	(a+b+c+d)360

Positive coincidence rate=[a/(a+c)]×100%=[153/(153+0)]×100%=100%;

Negative coincidence rate=[d(b+d)]×100%=[207/(207+0)]×100%=100%;

Totalcoincidencerate=[(a+d)/(a+b+c+d)]×100%=[(153+207)/(360)]×100%=100%.

		Predicate DeviceWondfo One Step HCG Urine Test
		Positive	Negative	total
Proposed DeviceDavid Home PregnancyTest Cassette	Positive	(a)153	(b)0	$(a+b)153$
	Negative	(c)0	(d)207	$(c+d)207$
	total	$(a+c)153$	$(b+d)207$	$(a+b+c+d)360$

Table: statistic analysis of data (professionals)

Positive coincidence rate=[a((a+c)] x100%=[153/(153+0)]×100%=100% ;

Negative coincidence rate=[d/(b+d)]×100%=[207/(207+0)]×100%=100% ;

Totalcoincidencerate=[(a+d)/(a+b+c+d)]×100%=[(153+207)/(360)]×100%=100%.

Table: statistic analysis of data (David Home Pregnancy Test Cassette)

		Results of Professionals
		Positive	Negative	total
Results ofnon-Professionals	Positive	(a)153	(b)0	(a+b)153
	Negative	(c)0	(d)207	(c+d)207
	total	(a+c)153	(b+d)207	(a+b+c+d)360

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Positive coincidence rate=[a/(a+c)]×100%=[153/(153+0)]×100%=100%; Negative coincidence rate=[d/(b+d)] ×100%=[207/(207+0)]×100%=100% Total coincidence rate=[(a+d)(a+b+c+d)]×100%=[(153+207)/(360)]×100%=100%.

b.Lay-user study:

After finishing the comparison study, 40 female volunteers aged from 18-45 and of different occupation and education were selected from each of the three sites, for a total of 120 volunteers to participate in the lay-user study and and fill-out questionnaires to evaluate the users comprehension of the instructions for use. Lay users conducted the test according to the English instructions for use for the David Home Pregnancy Test Cassette without any assistance. After finishing the test on their own samples, all the 120 volunteers were asked to test 3 other samples spiked with HCG different of HCG27.5mIU/mL). Every volunteer randomly selected one set of double-blind numbered samples to test. The results showed that all the test results of samples containing 27.5mIU/mL of HCG are positive and 99% of the test results of samples containing 20mIU/mL of HCG are negative.

Every lay-user participant was asked to answer the Likert scale style questions in the questionnaire after finishing the above test. The respondents specified their level of agreement or disagreement to a statement on a scale of 1 to 5,for example, 1-strongly disagree, 2-disagree, 3-neither agree or disagree, 4-agree, and 5-strongly agree. The results of the questionnaire reflected that the lay-users found the test to be easy to use and that they did not have trouble understanding the labeling or interpreting results. The Flesch-Kincaid software was used to assess the readability of the packaging labels for lay-user use and the results show that the labels can be understood by people with no more than 8th grade education.

M.CONCLUSION:

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

Regulation Number and Section

§ 862.1155 Human chorionic gonadotropin (HCG) test system.

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