ONE STEP HCG URINE PREGNANCY TEST

K043443 · Guangzhou Wondfo Biotech Co., Ltd. · LCX · Apr 8, 2005 · Clinical Chemistry

Device Facts

• Record ID: K043443
• Device Name: ONE STEP HCG URINE PREGNANCY TEST
• Applicant: Guangzhou Wondfo Biotech Co., Ltd.
• Product Code: LCX · Clinical Chemistry
• Decision Date: Apr 8, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

The Guangzhou Wondfo Biotech Co., Ltd. One Step HCG Urine Pregnancy Test is intended for non-professional, over-the-counter use and for professional and laboratory use for the qualitative identification of the elevated levels of human Chorionic Gonadotrophin (hCG) in urine to aid in the determination of pregnancy.

Device Story

Solid-phase, sandwich immunochromatographic assay; detects hCG in urine. User soaks absorbent pad with urine; sample migrates via capillary action through membrane coated with mouse monoclonal anti-α-hCG antibody and pad containing mouse monoclonal anti-β-hCG antibody colloidal gold conjugate. Presence of hCG forms colored line in test region; control line indicates valid test. Used in home or clinical settings; operated by patients or healthcare professionals. Visual readout at 5 minutes; positive result indicates elevated hCG levels consistent with pregnancy. Benefits include rapid, qualitative pregnancy confirmation.

Clinical Evidence

No clinical data provided; substantial equivalence established via bench testing and comparison to legally marketed predicate devices.

Technological Characteristics

Solid-phase, sandwich immunochromatographic assay. Materials: membrane coated with mouse monoclonal anti-α-hCG antibody; pad with mouse monoclonal anti-β-hCG antibody colloidal gold conjugate; goat anti-mouse IgG control. Formats: strip, cassette, midstream. Storage: 4–30 °C. Traceable to WHO 3rd International Standard. No electronic components or software.

Indications for Use

Indicated for qualitative detection of hCG in urine to aid pregnancy determination in women of childbearing age. Suitable for over-the-counter, professional, and laboratory use.

Regulatory Classification

Identification

A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine. A human chorionic goadotropin (HCG) test system is a device intended for any uses other than early detection of pregnancy (such as an aid in the diagnosis, prognosis, and management of treatment of persons with certain tumors or carcinomas) is intended to measure HCG, a placental hormone, in plasma or urine.

Predicate Devices

• WHPM One-Step Pregnancy Test (k041273)
• Acon Quick-Check II Home pregnancy Test (k032510)
• Acon Quick-Check II Home pregnancy Test Strip (k033041)
• Accutest hCG-Combo (k032987)
• E.P.T. Pregnancy Test (k033658)
• Unimark Home Pregnancy Test Device (k032992)
• Good Morning Test (k031798)

Submission Summary (Full Text)

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## Exhibit 1 510(k) Summary

| 1 | 510(k) Summary | | | | |
|-----|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|
| | Date of Summary Preparation: | May 17, 2004 | | | |
| 1.2 | Submitter: | Mr. Jason Zhou<br>Guangzhou Wondfo Biotech Co., Ltd.<br>WONDFO Scientech Park<br>South China University of Technology<br>Guangzhou, Guangdong, PRC, 510641<br>E-mail: [e-mail] | | | |
| 1.3 | Trade Name: | One Step HCG Urine Pregnancy Test | | | |

- Classification Name, Product Code, Class, Classification Reference: 1.4

| Classification Name | Common Name | Product Code | Class | 21CFR § |
|------------------------------------------------------------|----------------|--------------|-------|----------|
| Kit, test, pregnancy, hcg, over the counter | Pregnancy Test | LCX | II | 862.1155 |
| Kit, test, pregnancy, hcg, professional and laboratory use | Pregnancy Test | JHI | II | 862.1155 |

- Standards/Special Controls: 1.5
None

- Indications for Use: 1.6
The Guangzhou Wondfo Biotech Co., Ltd. One Step HCG Urine Pregnany Test is The Guangzhou Wondlo Blocen Co., Ltd. Cho Sep of Corporasional use for the intended for non-professional, over-the-counter ass all-al-connectionic Gonadotropin (hCG) qualitative fut in the determination of pregnancy.

The One Step HCG Urine Pregnancy Test is intended for use by professional healthcare I ne One Stop in its use and for Over-the-Counter use.

Device Description: 1.7

The device consists of a single test strip with one end designated for dipping, and ontrol The device consists of a single test sup whil one arows indicating which end of and test regions in the middle. At one cha of the samplar hat the strip should not be dipped below this line.

The One Step HCG Urine Pregnancy Test device is similar in design, materials and The One Step HCG Orme Tregiancy "Fost dones" is and in commercial distribution.

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Substantially Equivalent Commercially Available Devices: 1.8

The One Step HCG Urine Pregnancy Test device is substantially equivalent to the The One Step HCC Orme Fregnaticy rest device to indications for use, device design, predicts, and method of manufacture:

Unipath, Ltd, E.P.T. Pregnancy Test - K033658 Unipath, Ltd, E.P.T. Freghancy Test - Rose over Test Device - K032992
Biotech Atlantic, Inc., Unimark Home Pregnancy Test Device - Kest Biotech Atlantic, Inc., Onlinark Home Pregnancy Test Development
Acon Laboratories, Inc., Acon Quick-Check II Home Pregnancy Test Strip --K033041 K033041
Standard Diagnostics, Inc., Good Morning Test - K031798

The predicate devices are commercially available and marketed Class II devices indicated The predicate devices are commercially avainter use and for professional use for the for use for non-professional, belevated levels of human Chorionic Gonadotropin (hCG) qualitative identified determination of pregnancy.

- Substantial Equivalence Comparison: 1.9
See Section 5: Comparison Chart.

- Indications and Contraindications: 1.10
Relative indications and contraindications for the Guangzhou Worldfo Biotech Co., Ltd.
Contrally and Relative indications and contraindications for the Stangence - 1 similar
One Step HCG Urine Pregnancy Test and commercially available devices for similar intended uses are the same.

Conclusion: 1.11

In accordance with the Federal Food, Drug and Cosmetic Act and 21 CFR Part 807, and In accordance with the Federal Food, Drug and Cosment , Guangzhou Wondfor based on the information provided in this provide no HCC Urine Pregnancy Test, is
Biotech Co., Ltd concludes that the new devices davices described herein. Biotech Co., Ltd concludes mat the new device, One Beep X B = = = = = =
safe, effective and substantially equivalent to the predicate device as described herein.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and head. The eagle is positioned to the right of a circular emblem containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged around the circumference of the circle.

APR 7 2005 Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Guangzhou Wondfo Biotech Co., Ltd. c/o Mr. Howard Mann Sherbo Associates 8903 Spruce Mill Drive Yardley, PA 19067

k043443 Re:

Trade/Device Name: One Step HCG Urine Pregnancy Test Regulation Number: 21 CFR 862.1155 Regulation Name: 21 OF Roconic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: LCX, JHI Dated: February 26, 2005 Received: February 28, 2005

Dear Mr. Mann:

We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section of the device is substantially equivalent (for the indications
referenced above and have determined the devices marketed in interstate referenced above and nave decembined the arrest soredicate devices marketed in interstate for use stated in the encrosure) to regally manced predical Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Food commerce prior to May 28, 1970, the channell and start of the Federal Food, Drug, devices that have been reclassified in accordance who a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premaining of the Act . and Cosment Act (Act) that do not require approval controls provisions of the Act. The Act. The Act. The You may, merelore, market the device, saojeet to the generals for annual registration, listing of general controls provisions of the Fect morado required in against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classifica (SCC above) into c. Existing major regulations affecting your device in editions a it may be subject to such additional controls. "Disting migrises" on and 10 895. In addition, FDA can be found in Title 21, Code of I each in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised fillat I DA s issualles of a substition with other requirements of the Act that FDA has made a decertifications administered by other Federal agencies. You must be or any Federal statutes and regulations administered by the registration and listing (21 comply with an the Act 3 requirements, mo and 809); and good manufacturing practice CFR Part 807), labeling (21 CF R F R Lists over ms (QS) regulation (21 CFR Part 820).

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Page 2 -

This letter will allow you to begin marketing your device as described in your bection 510(k) I his letter will anow you to ocgin marketing of substantial equivalence of your device to a legally premarket notification: "The PDT Intamig cification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, of k If you desire specific information acount in apparation, please contact the Office of In
or questions on the promotion and advertising of your device, please contact the Offi or questions on the promotion and Safety at [phone]. Also, please note the Pliro Diagliostic Device Livatiation and Sales to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the You may onant outer general informational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Jean M. Cooper MS, DUM

Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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EXHIBIT B

Indications for Use Statement

## Indications for Use

510(k) Number (if known):

One Step HCG Urine Pregnancy Test Device Name:

Indications for Use:

The Guangzhou Wondfo Biotech Co., Ltd. One Step HCG Urine Pregnancy Test is I he Guangzilou Wondto Dioloen Oo., Etar Silver Stores on the professional and laboratory
intended for non-professional, over-the-counter use and for professional and laborat intended for non-professional, over the elevated levels of human Chorionic Gonadotropin (hCG) in urine to aid in the determination of pregnancy.

The One Step HCG Urine Pregnancy Test is intended for use by professional healthcare personnel trained in its use and for Over-the-Counter use.

Prescription Use_ V (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

**Division Sign-Off**

Office of In Vitro Diagno

510(k) K043443