DAVID PREGNANCY TEST (MIDSTREAM)

K053236 · Runbio Biotech Co.,Ltd · LCX · Jul 18, 2006 · Clinical Chemistry

Device Facts

• Record ID: K053236
• Device Name: DAVID PREGNANCY TEST (MIDSTREAM)
• Applicant: Runbio Biotech Co.,Ltd
• Product Code: LCX · Clinical Chemistry
• Decision Date: Jul 18, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

David Pregnancy Test is a self-testing immunoassay designed for the qualitative determination of human chorionic gonadotropin (hCG) in the urine to aid in early detection of pregnancy. It is for over-the-counter use.

Device Story

David Pregnancy Test is a lateral flow immunoassay for qualitative detection of hCG in urine. Device formats include test strips and midstream devices. User collects urine sample; applies to test device; hCG, if present, binds to labeled antibodies; results appear as visual color bands on test membrane. Intended for home use by lay individuals for early pregnancy detection. Results interpreted visually by user based on presence or absence of test line relative to control line. Provides rapid qualitative assessment to aid in pregnancy confirmation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Lateral flow immunochromatographic assay. Qualitative detection of hCG in urine. Formats: test strip and midstream device. Visual readout via colorimetric antibody-antigen binding. Non-electronic, standalone diagnostic test.

Indications for Use

Indicated for qualitative detection of hCG in urine to aid in early pregnancy detection; for over-the-counter self-testing use by women.

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.

Submission Summary (Full Text)

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K053236

### 510(K) SUMMARY

JUL 1 8 2006

DATE OF SUMMARY: NOVEMBER 3, 2005

# SUBMITTER & CORRESPONDENT IN THE UNITED STATES:

NATIONAL BUSINESS GROUP INC. 2941 6181. AVE NE TACOMA WA 98422 CONTACT# 253-238-6409

## MANUFACTURED BY:

RUNBIO BIO TECH CO., LTD RONGSHENG TECHNOLOGICAL ZONE, UNIVERSITY ROAD SHANTOU, GUANGDONG, CHINA 515063

## DEVICE NAME:

DAVID PREGNANCY TEST (STRIP AND MIDSTREAM)

#### DEVICECLASSIFICATION NAME:

PREGNANCY, TEST, KIT, HCG, MIDSTREAM, TEST STRIP, OVER-THE-COUNTER

CLASSIFICATION NUMBER: 862.1155

FDA PRODUCT CODE: LCX

MEDCAL SPECIALTY: CLINICAL CHEMISTRY

#### INTENDEND USE:

DAVID PREGNANCY TEST IS A SELF-TESTING IMMUNOASSAY DESIGNED FOR THE QUALITATIVE DETERMINATION OF HUMAN CHORIONIC GONADOTROPIN (HCG) IN THE URINE TO AID IN EARLY DETECTION OF PREGNANCY. IT IS FOR THE OVER-THE-COUNTER-USE

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, composed of three overlapping profiles facing to the right. The figure is positioned in the center of a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged around the upper half of the circle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP 2 6 2006

Runbio Biotech Co., Ltd. c/o Ms. Jessica Vagata National Business Group Inc. 2941 61st Ave. NE Tacoma, WA 98422

Re: k053236

Trade/Device Name: David Pregnancy Test (Strip and Midstream) Regulation Number: 21 CFR§ 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: LCX Dated: June 19, 2006 Received: June 22, 2006

Dear Ms. Vagata:

This letter corrects our substantially equivalent letter of July 18, 2006.

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.

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Page 2 - Ms. Jessica Vagata

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); 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 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, 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" (21CFR Part 807.97). 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 vours,

Carol C. Bensenfor

Alberto Gutierrez, Ph.D. 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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Indications for Use

510(k) Number: K053236

Device Name: DAVID PREGNANCY TEST (STRIP AND MIDSTREAM)

Indications For Use:

DAVID PREGNANCY TEST IS A SELF-TESTING IMMUNOASSAY DESIGNED FOR THE QUALITATIVE DETERMINATION OF HUMAN CHORIONIC GONADOTROPIN (HCG) IN THE URINE TO AID IN EARLY DETECTION OF PREGNANCY. IT IS FOR THE OVER-THE-COUNTER-USE

Prescription Use (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 In Vitro Diagnostic Devices (OIVD) | |
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| 510(k) | k053236 |