Wunder Pregnancy Test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in human urine. The device is visually read as an aid for the early detection of pregnancy and intended for in vitro single use. This test is intended for prescription use including at point-of-care sites.

Device Description

Wunder Pregnancy Test is a single-use qualitative immunochromatic lateral flow device intended to detect human chorionic gonadotropin (hCG) in urine to help in the early detection of pregnancy. The device is visually read and intended for prescription use. Wunder Pregnancy Test is provided in a cassette format. A pipette is included for use with the device. The operator utilizes the included pipette to collect a sample of urine specimen to be tested from a sample cup. The operator then dispenses the urine specimen into the round sample well of the device. An absorbent, nitrocellulose membrane strip is incorporated in the sample well into the rectangular window where the results are read. In the results window, there are two band regions on the membrane strip, a test band and a control band. The test band region is pre-coated with Goat anti-a hCG antibodies. Goat anti-β monoclonal antibodies are placed on the membrane between the test band and the sample well. During the test, the urine sample is allowed to migrate upward and hydrate the anti-β monoclonal antibodies. The mixture then migrates along the membrane by capillary action to the immobilized Goat anti-α hCG antibodies in the test band region. In the presence of hCG in the urine, the anti-ß monoclonal antibodies bind with the hCG ß unit antigen and moves with the sample urine fluid by capillary action along the membrane. As the solution reaches the test band, the antibody hCG ß-unit antigen complex becomes linked to the pre-coated Goat anti-a hCG antibodies to form a visible precipitate that can be seen as a color line at the test band. Therefore, the formation of a visible color line on the test band region indicates the urine sample has tested positive for hCG. In the absence of hCG in the urine, the anti-ß monoclonal antibodies bypass the pre-coated Goat anti-q hCG antibodies in the test region without forming a visible precipitate. As a result, the absence of a visible color line in the test band region indicates the urine sample tested is negative for hCG. The distal control band region is pre-coated with Goat anti Mouse IgG. If there is sufficient urine volume, the anti-ß antibodies will migrate by capillary action to the control region. The anti-ß antibodies will bind with the Goat anti Mouse IgG and precipitate to form a color line. This antigen-antibody reaction at the control line ensures that the test is performed properly and should always be seen as a visible line duringtesting. The presence of this color band in the control region serves as verification that sufficient urine volume has been added and that proper flow was obtained. In conclusion, a valid positive urine sample produces two distinct color bands. A valid negative sample produces only one color band in the control zone.

AI/ML Overview

Here's an analysis of the acceptance criteria and study details for the "Wunder Pregnancy Test" based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria (Implied)	Reported Device Performance
Method Comparison	High agreement with predicate device	100% positive agreement (69/69), 100% negative agreement (31/31) with predicate device (dBest Pregnancy Test) for 100 clinical urine samples. Overall >99% agreement.
Sensitivity (Cut-off)	Accurate detection at the established cut-off	100% agreement (60/0) at 25 mIU/mL hCG.
Specificity	No interference from common hormones (hLH, hFSH, hTSH)	No interference observed when testing hCG with hLH (500 mlU/mL), hFSH (1000mlU/mL), and hTSH (1000 µlU/mL) in urine samples containing 0 and 25 mlU/mL hCG.
Interference (hCG beta-core fragment)	Correct results at or below a specified concentration	Correct results obtained in the presence of hCG beta-core fragment at a concentration equal to or less than 250,000 pmol/L. False negative occurred at concentrations in excess of 250,000 pmol/L.
Interference (Hook Effect)	Correct results at or below a specified high hCG concentration	Correct results obtained when testing urine samples with hCG concentrations equal to 1,000,000 mlU/mL. False negative occurred at concentrations in excess of 1,000,000 mlU/mL.
Interference (Endogenous/Exogenous Substances)	No interference from a list of common substances	No interference observed from various substances (Acetaminophen, Acetylsalicylic acid, Atropine, L-Ascorbic acid, Caffeine, Salicylic acid, Ampicillin, Glucose, Hemoglobin, Benzoylecgonine, Albumin, Bilirubin, Ethanol) at specified concentrations. Urine specific gravity (1.000-1.030) and urine pH (3-9) also did not interfere.

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

Method Comparison Study: 100 female patient urine samples. Data provenance is implied to be prospective and clinical, as samples were "collected and tested at three point of care locations." The country of origin is not explicitly stated.
Sensitivity Study: 60 samples per hCG concentration level, for a total of 360 samples (60 samples x 6 concentrations: 0, 12.5, 20, 25, 37.5, 50, 100 mlU/mL - though the table only lists 7 concentrations, the summary states 60 samples per level). These were "urine samples from nonpregnant subjects were spiked with hCG," so this is a contrived, laboratory-based test set. Data provenance is not specified for country.
Specificity, Interference (hCG beta-core fragment, Hook effect, Endogenous/Exogenous Substances): The sample sizes for these studies are not explicitly stated, but it implies multiple tests were conducted for each condition. These were also laboratory-based studies using spiked samples, not clinical patient samples for the interference parts.

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

For Method Comparison: The ground truth for the 100 clinical samples was established by the predicate device (dBest Pregnancy Test). No human experts are explicitly mentioned as establishing a separate ground truth. The results of the Wunder Pregnancy Test were compared against the predicate device's results.
For Sensitivity, Specificity, and Interference Studies: The ground truth was based on the known, spiked concentrations of hCG or other substances. No human experts were involved in establishing this ground truth, as it was chemically determined.

4. Adjudication Method for the Test Set

For Method Comparison: No adjudication method is explicitly stated. The comparison was directly between the Wunder Pregnancy Test results and the predicate device's results. It's implied that the predicate device's result served as the "truth" for comparison.
For other studies: Not applicable, as ground truth was based on known chemical concentrations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not reported. The studies focused on the performance of the device itself (standalone) or its agreement with a predicate device. There is no mention of human readers improving with or without AI assistance, as this is a visually read qualitative immunoassay, not an AI-assisted diagnostic tool.

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

Yes, the studies reported are essentially standalone performance studies for the device. The "Wunder Pregnancy Test" is a visually read device, meaning its "performance" is its intrinsic ability to produce a correct visual output based on the presence or absence of hCG. The performance results (sensitivity, specificity, agreement with predicate) are for the device itself. While a human reads the result, the performance metrics evaluate the device's ability to generate the correct visual signal.

7. The Type of Ground Truth Used

Method Comparison: The ground truth was implicitly the result of the legally marketed predicate device (dBest Pregnancy Test) for the 100 clinical samples.
Sensitivity, Specificity, Intervention Studies: The ground truth was based on known, controlled concentrations of hCG or other substances in laboratory-prepared (spiked) urine samples. This can be considered a form of analytical truth based on controlled experimental conditions.

8. The Sample Size for the Training Set

This information is not provided. The 510(k) summary describes performance testing for submission, not the development or training of the device. Given that this is a lateral flow immunoassay not an AI/ML device, a "training set" in the computational sense does not apply. The device's biological components (antibodies, etc.) are developed and manufactured, not "trained" on data.

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

As stated above, this is not applicable as the device is not an AI/ML model requiring a training set with established ground truth in that context. Its "training" would be the scientific and engineering development, optimization, and manufacturing processes of the immunoassay itself.

Summary

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

K130456

APR 0 8 2014

510(k) SUMMARY

Submitter's Name, address, telephone number, a contact person and date the summary was prepared:

Submitter's Name:	James Nguyen, M.D.
Submitter's Address:	2231 Fortune Dr., Ste. DSan Jose, CA 95131
Submitter's Email:	herrsonic@hotmail.com
Submitter's Telephone:	408-972-7464
Submitter's Fax:	408-954-8800
Submitter's Contact:	James Nguyen, M.D.
Date 510(k) summary prepared:	March 8, 2014

Name of the device, including the trade or proprietary name if applicable, the common or usual name and the classification name, if known:

Proprietary Name:	Wunder Pregnancy Test
Common or Usual Name:	Chorionic gonadotropin test system
Classification Name:Classification Code:	Enzyme immunoassay, hCG21 CFR 862.1155, Class II
Product Code:	JHI

Description of the Device:

Wunder Pregnancy Test is provided in a cassette format. A pipette is included for use with the device. The operator utilizes the included pipette to collect a sample of urine specimen to be tested from a sample cup. The operator then dispenses the urine specimen into the round sample well of the device. An absorbent, nitrocellulose membrane strip is incorporated in the sample well into the rectangular window where the results are read. In the results window, there are two band regions on the membrane strip, a test band and a control band. The test band region is pre-coated with Goat anti-a hCG antibodies. Goat anti-β monoclonal antibodies are placed on the membrane between the test band and the sample well. During the test, the urine sample is allowed to migrate upward and hydrate the anti-β monoclonal antibodies. The mixture then migrates along the membrane by capillary action to the immobilized Goat anti-α hCG antibodies in the test band region.

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

In the presence of hCG in the urine, the anti-ß monoclonal antibodies bind with the hCG ß unit antigen and moves with the sample urine fluid by capillary action along the membrane. As the solution reaches the test band, the antibody hCG ß-unit antigen complex becomes linked to the pre-coated Goat anti-a hCG antibodies to form a visible precipitate that can be seen as a color line at the test band. Therefore, the formation of a visible color line on the test band region indicates the urine sample has tested positive for hCG.

In the absence of hCG in the urine, the anti-ß monoclonal antibodies bypass the pre-coated Goat anti-q hCG antibodies in the test region without forming a visible precipitate. As a result, the absence of a visible color line in the test band region indicates the urine sample tested is negative for hCG.

The distal control band region is pre-coated with Goat anti Mouse IgG. If there is sufficient urine volume, the anti-ß antibodies will migrate by capillary action to the control region. The anti-ß antibodies will bind with the Goat anti Mouse IgG and precipitate to form a color line. This antigen-antibody reaction at the control line ensures that the test is performed properly and should always be seen as a visible line duringtesting. The presence of this color band in the control region serves as verification that sufficient urine volume has been added and that proper flow was obtained. In conclusion, a valid positive urine sample produces two distinct color bands. A valid negative sample produces only one color band in the control zone.

Statement of the Intended Use:

Summary of the technological characteristics of the device compared to the predicate devices

Performance of the Wunder Pregnancy Test was compared to dBest Pregnancy Test (510k # K061257). Both tests are immunochromatic, lateral flow assays for the qualitative detection of hCG in urine. Both tests are intended to provide preliminary pregnancy test results.

Similarities
Features	Device	Predicate
Name	Wunder Pregnancy Test	dBest Pregnancy Test
Intended use	For detection of hCG as anaid in the early detection ofpregnancy	Identical

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

Mechanism of action	Immunochromatographic lateral flow assay with visual, qualitative screening result	Identical
Time to result	5 minutes	Identical
Reusability	No, one-time use	Identical
Use	Prescription	Prescription and OTC

Differences
Features	Device	Predicate
Name	Wunder Pregnancy Test	dBest Pregnancy Test
Product design	Cassette	Dipstick
Size	Smaller size (2.72" x 0.75" x 0.18")	Larger size (5.25" x 0.6" x 0.4")
Physical design	Plastic casing with round "sample well" for urine collection with a provided pipette	Plastic casing with absorbent tip in a dipstick case
Storage temperature	18-28°C (64-82°F)	4-30°C (40-86°F)

Summary of Performance Testing:

1. Method Comparison Study
  100 female patient urine samples were collected and tested at three point of care locations and compared to the predicate device. Patients included women with suspected pregnancy and with possible pregnancy gestational age up to 10 weeks. The results of the comparison with the predicate device were as follows:

	Commercially Available Pregnancy Test
	+	-	Total
WunderPregnancyTest	+	69	0	69
	-	0	31	31
	Total	69	31	100

1. Sensitivity
  To evaluate sensitivity, urine samples from nonpregnant subjects were spiked with hCG to concentrations of 0, 12.5, 25, 37.5, 50 and 100 mlU/mL and tested at three point of care locations. The study establishes the cut-off value for the Wunder Test Pregnancy Test at 25 mIU/mL.

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

hCGlevelsmlU/mL	Total No.Tested	%Agreement	Results(+/-)
0	60	100	0/60
12.5	60	100	0/60
20	60	51	31/29
25	60	100	60/0
37.5	60	100	60/0
50	60	100	60/0
100	60	100	60/0

3. Specificity

No interference was observed in the testing of hCG using the Wunder Pregnancy Test when the following concentrations of hormones were added to urine samples containing 0 and 25 mlU/mL hCG: hLH 500 mlU/mL, hFSH 1000mlU/mL, and hTSH, 1000 µlU/mL.

1. Interference Data
- a. Interference effect of the hCG beta-core fragment

hCG beta core fragment was tested at increasing concentrations and found to produce a false negative test result at a concentration in excess of 250,000 pmol/L. Correct results were obtained in the presence of hCG beta-core fragment at concentration equal to or less than 250,000 pmol/L.

b. Hook effect
In evaluating for high dose hook effect, negative urine specimens were spiked with high hCG concentrations and found to produce a false negative test result at a concentration in excess of 1,000,000 mlU/mL. Correct results were obtained when testing urine samples with hCG concentrations equal to 1,000,000 mlU/mL with this device.

c. Interference effects of endogenous and exogenous substances

The following substances were found not to interfere with the Wunder Pregnancy Test.

Acetaminophen	20 mg/dL
Acetylsalicylic acid	20 mg/dL
Atropine	20 mg/dL
L-Ascorbic acid	20 mg/dL
Caffeine	20 mg/dL
Salicylic acid	20 mg/dL
Ampicillin	20 mg/dL
Glucose	2 mg/dL
Hemoglobin	1000 mg/dL
Benzoylecgonine	10 mg/dL
Albumin	100 mg/dL
Bilirubin	2 mg/dL
Ethanol	1%

Urine specific gravity (1.000-1.030) and urine pH (3-9) do not interfere with the test results of the Wunder Test Pregnancy Test.

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

5. Conclusions

Study data support the determination of substantial equivalence of the Wunder Pregnancy Test to the predicate device. Comparison testing of 100 clinical samples demonstrate a >99% agreement of the Wunder Pregnancy Test with the predicate device. The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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

Image /page/5/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 8, 2014

JAMES NGUYEN, M.D. 2231 FORTUNE DR, STE D SAN JOSE CA 95131

Re: K130456

Trade/Device Name: Wunder Pregnancy Test Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: II Product Code: JHI Dated: February 20, 2014 Received: February 24, 2014

Dear Dr. Nguyen:

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 ffor 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 mislcading.

If your device is classified (sec above) into cither 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 Parts 801 and 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 clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Small Manufacturers. International and Consumer

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

Page 2-Dr. Nguyen

Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.html for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Courtney H. Lias -S

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

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

Indications for Use

510(k) Number (if known) k 130456

Device Name

Wunder Pregnancy Test

Indications for Use (Describe)

Wunder Pregnancy Test is a rapid chromatographic innunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in human urine. The device is visually read as an aid for the early detection of pregnancy and intended for in vitro single use. This test is for prescription use including at point-of-care sites.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signalure)

Avis T. Danishefsky -S

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."

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.