(410 days)
Not Found
No
The device description details a standard lateral flow immunoassay with visual interpretation, and there is no mention of AI, ML, or image processing in the summary.
No
The device is a diagnostic tool used to detect the presence of human chorionic gonadotropin (hCG) for pregnancy detection, not to treat or cure a medical condition.
Yes
Explanation: The device is intended "as an aid for the early detection of pregnancy," which is a diagnostic purpose, by detecting hCG, a biomarker for pregnancy.
No
The device description clearly outlines a physical, single-use immunochromatic lateral flow device with a pipette, membrane strip, and chemical reagents for detecting hCG in urine. It is visually read and does not mention any software component.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the Wunder Pregnancy Test is "intended for in vitro single use."
- Device Description: The description details how the test works by analyzing a biological sample (urine) outside of the body to detect a specific analyte (hCG) for diagnostic purposes (early detection of pregnancy).
- Nature of the Test: It's a rapid chromatographic immunoassay, which is a common type of in vitro diagnostic test.
The definition of an IVD is a medical device that is used to examine specimens, such as blood, tissue, or urine, taken from the human body to help diagnose diseases or conditions. The Wunder Pregnancy Test fits this definition perfectly.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
JHI
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.
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
Prescription Use, point-of-care sites.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
- 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 study showed a >99% agreement with the predicate device.
- Sensitivity Study: 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 established the cut-off value for the Wunder Test Pregnancy Test at 25 mIU/mL. For 25 mIU/mL and above, there was 100% agreement (60/0 results for positive/negative).
- Specificity Study: No interference was observed with hLH 500 mlU/mL, hFSH 1000mlU/mL, and hTSH, 1000 µlU/mL in urine samples with 0 and 25 mlU/mL hCG.
- Interference Data:
- hCG beta-core fragment: produced a false negative at concentrations in excess of 250,000 pmol/L. Correct results were obtained at concentrations equal to or less than 250,000 pmol/L.
- Hook effect: produced a false negative result at concentrations in excess of 1,000,000 mlU/mL. Correct results were obtained at concentrations equal to 1,000,000 mlU/mL.
- Endogenous and exogenous substances: Acetaminophen, Acetylsalicylic acid, Atropine, L-Ascorbic acid, Caffeine, Salicylic acid, Ampicillin, Glucose, Hemoglobin, Benzoylecgonine, Albumin, Bilirubin, Ethanol were found not to interfere.
- Urine specific gravity (1.000-1.030) and urine pH (3-9) do not interfere.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Agreement with predicate device: >99%
- Sensitivity cut-off value: 25 mIU/mL for hCG.
- Specificity: No interference from common hormones (hLH, hFSH, hTSH) at tested concentrations.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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. D |
| San 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, hCG |
| 21 CFR 862.1155, Class II | |
| Product Code: | JHI |
Description of the Device:
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.
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:
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.
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 an | |
| aid in the early detection of | ||
| pregnancy | 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:
-
- 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:
- Method Comparison Study
| Commercially Available Pregnancy Test | ||||
|---|---|---|---|---|
| + | - | Total | ||
| Wunder | ||||
| Pregnancy | ||||
| Test | + | 69 | 0 | 69 |
| - | 0 | 31 | 31 | |
| Total | 69 | 31 | 100 |
-
- 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.
- Sensitivity
3
| hCG
levels
mlU/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.
-
- 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
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