ONE STEP HCG URINE/SERUM TEST

K072500 · Guangzhou Wondfo Biotech Co., Ltd. · DHA · Apr 21, 2009 · Clinical Chemistry

Device Facts

• Record ID: K072500
• Device Name: ONE STEP HCG URINE/SERUM TEST
• Applicant: Guangzhou Wondfo Biotech Co., Ltd.
• Product Code: DHA · Clinical Chemistry
• Decision Date: Apr 21, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

The Wondfo One Step hCG Urine/Serum in vitro diagnostic test is used for the qualitative determination of human chorionic gonadotropin (hCG) in urine or serum to aid in the early detection of pregnancy. It is intended for professional use only (Clinical Laboratory Use).

Device Story

The Wondfo One Step hCG Urine/Serum Test is a lateral flow immunochromatographic assay for the qualitative detection of hCG in urine or serum. The device is available as a test strip or cassette. It utilizes mouse monoclonal anti-beta hCG antibodies on a sample pad and mouse monoclonal anti-alpha hCG antibodies on a membrane test line. The test is performed by immersing the device in a sample; hCG, if present at or above 25 mIU/mL, binds to the antibodies, creating a visible red band at the test line. A control line confirms sufficient sample volume. The test is intended for professional use in clinical laboratories to aid in pregnancy detection. Results are read visually by a clinician within 3 to 5 minutes. High concentrations of hCG (>100 IU/mL) may cause a hook effect, potentially leading to false-negative results.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing of the immunochromatographic assay performance.

Technological Characteristics

Lateral flow immunochromatographic assay. Components: mouse monoclonal anti-beta hCG antibody (sample pad), mouse monoclonal anti-alpha hCG antibody (test line), goat anti-mouse IgG (control line). Cut-off: 25 mIU/mL. Formats: strip and cassette. Standardized to WHO 3rd International Standard. No electronic components or software.

Indications for Use

Indicated for qualitative determination of human chorionic gonadotropin (HCG) in human serum or urine to aid in early pregnancy detection. Intended for professional clinical laboratory use only.

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

• Acon Laboratories, Inc. HCG One Step Urine/Serum Pregnancy Test (K980736)

Submission Summary (Full Text)

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## SECTION 4

## SUMMARY

K072500

Submitter's name: Address:

Phone:

Name of contact person:

Guangzhou Wondfo Biotech Co., Ltd. South China University of Technology Guangzhou, P.R. China 510641 00-86-20-871-1274-8668

APR 2 1 2009

Howard Mann SHERBO ASSOCIATES 8903 Spruce Mill Drive . Yardley, PA 19067 Phone: [phone] Fax: [phone]

Date the summary was prepared:

August 28, 2007

Name of the device: Trade or proprietary name: Common or usual name:

One Step HCG Urine/Serum Test One Step HCG Urine/Serum Test HCG Urine/Serum Test

Classification: All are Class II medical devices with the following product code and Code of Federal Regulation references:

> Product Code CFR # DHA 862.1155

The legally marketed device to which we are claiming equivalence [807.92(a)(3)]: Acon Laboratories, Inc. HCG One Step Urine/Serum Pregnancy Test, K980736.

Description of the device:

Assay Principle: Human Chorionic Gonadotropin (HCG) is one of the glycoproteins secreted by the placenta. It contains a-and ß-subunits. The a-subunit of HCG shows cross-reactions with LH, TSH and FSH, because of similarities in the amino acid sequences. However, the Bsubunit of HCG is specific, and shows the lowest cross reactions in assays. The antibodies, which were used before in HCG detection, were directed against the whole HCG molecule, and therefore regularly presented cross reactions with LH and TSH. Wondfo One Step HCG Urine/Serum Test is aimed to be a HCG specific test by using a monoclonal antibody against highly purified B-HCG. Immunochromatograph assay for hCG using a lateral flow, one step system for the qualitative detection of hCG in human urine/serum. Each assay uses a monoclonal antibody-dye congugate from mouse against β-HCG with gold chloride and fixed a-HCG antibody conjugate and anti-mouse IgG polyclonal antibody in membriance

Intended use of the device:

The One Step HCG Urine/Serum Test is used for the qualitative determination of HCG which appears in urine or serum for early detection of pregnancy. They are intended for professional use .

Summary of the technological characteristics of our device compared to the predicate device:

The Wondfo Biotech Co., Ltd. One Step HCG Urine/Serum Test have similar technological characteristics and performance to the predicate and are equivalent.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

APR 2 1 2009

Re: k072500

> Trade/Device Name: Wondfo One Step HCG Urine/Serum Test Regulation Number: 21 CFR §862.1155 Regulation Name: Human Chorionic Gonadotropin (HCG) Test System. Regulatory Class: Class II Product Code: DHA Dated: January 15, 2009 Received: January 21, 2009

Dear Mr. Mann:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing

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your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Courthey C. Harper, Ph.D. Acting 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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## Indication for Use

510(k) Number (if known): k072500

Device Name: Wondfo One Step HCG Urine/Serum Test

Indication For Use:

Wondfo One Step HCG Urine/Serum Test is an in-vitro diagnostic test for qualitative determination of human chorionic gonadotropin (HCG) in human serum or urine to aid in the early detection of pregnancy. It is intended for professional use only (Clinical Laboratory Use).

Prescription Use __ X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)

Carol Benson

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) Kin2500

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