KOREAMEDICO CHEXTIC HCG URINE PREGNANCY TEST

K062096 · Koreamedico Co. , Ltd. · LCX · May 7, 2007 · Clinical Chemistry

Device Facts

• Record ID: K062096
• Device Name: KOREAMEDICO CHEXTIC HCG URINE PREGNANCY TEST
• Applicant: Koreamedico Co. , Ltd.
• Product Code: LCX · Clinical Chemistry
• Decision Date: May 7, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

The Chextic is a rapid chromatographic immunoassay for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine to aid in the early detection of pregnancy. The device is intended for over-the-counter use.

Device Story

Chextic is a rapid chromatographic immunoassay for qualitative hCG detection in urine; aids early pregnancy detection. Device consists of a test strip in plastic housing; utilizes monoclonal anti-hCG and rabbit anti-mouse IgG antibodies. Intended for over-the-counter use by lay users. User applies urine sample to strip; results interpreted visually via presence or absence of lines. Provides qualitative positive/negative result; assists in clinical decision-making regarding pregnancy status. Benefits patient through rapid, accessible, home-based pregnancy screening.

Clinical Evidence

No clinical data provided; device relies on bench testing for performance validation of the immunoassay.

Technological Characteristics

Rapid chromatographic immunoassay; lateral flow test strip format; qualitative detection of hCG in urine; visual readout.

Indications for Use

Indicated for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine to aid in the early detection of pregnancy in individuals.

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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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black. The seal is simple and iconic, representing the department's role in protecting the health of all Americans.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

KoreaMedico Co., LTD. c/o Young-yong Kim Vice President 2F, 872-21 Hwagok 2-dong Gangseo-gu Seoul, 157-904 Republic of Korea

Re: k062096 Trade/Device Name: KoreaMedico Chextic hCG Urine Pregnancy Test Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system. Regulatory Class: Class II Product Code: LCX Dated: April 03, 2007 Received: April 05, 2007

MAY - 7 2007

Dear Mr. Kim:

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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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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 at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Jean M. Cooper, M.S., D.V.M.

Jean M. Cooper, M.S., 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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## Indications for Use

2012096 510(k) Number (if known):

Device Name:

KoreaMedico Chextic hCG Urine Pregnancy Test

Indications For Use:

The Chextic is a rapid chromatographic immunoassay for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine to aid in the early detection of pregnancy.

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

Over-The-Counter Use O (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)

Division Sign-Off

Office of In Vitro Diagnostic Device
Evaluation and Safety

K062096

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