ONE STEP HCG PREGNANCY TEST

K062703 · Ai DE Diagnostic Co., Ltd. · LCX · Jul 23, 2007 · Clinical Chemistry

Device Facts

• Record ID: K062703
• Device Name: ONE STEP HCG PREGNANCY TEST
• Applicant: Ai DE Diagnostic Co., Ltd.
• Product Code: LCX · Clinical Chemistry
• Decision Date: Jul 23, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

One Step HCG Urine Pregnancy Test is a rapid device, two sites sandwich immunoassay test device designed for the qualitative determination of human chorionic gonadotropin (hCG) concentration in human urine samples, and therefore is an aid in the early detection of pregnancy. These test devices are available in the formats of strip, cassette and midstream. The midstream format is intended for OTC use. The cassette and strip format are intended for both over-the-counter (OTC) use and use in clinical laboratories. One Step HCG Serum/Urine Combo Pregnancy Test is a rapid device, two sites sandwich immunoassay test device designed for the qualitative determination of human chorionic gonadotropin (hCG) concentration in human urine or serum samples, and therefore is an aid in the early detection of pregnancy. These test devices are available in strip format and cassette format, and are intended for professional use in clinical laboratories.

Device Story

Rapid, two-site sandwich immunoassay for qualitative hCG detection in human urine or serum. Device formats include strip, cassette, and midstream. Used in clinical laboratories by professionals or as OTC tests for home use. Principle of operation involves lateral flow immunoassay technology; presence of hCG in sample produces visual signal indicating pregnancy. Provides qualitative result to aid in early pregnancy detection. No complex instrumentation or software required; visual interpretation by user or clinician.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing of analytical performance characteristics typical for lateral flow immunoassay pregnancy tests.

Technological Characteristics

Two-site sandwich immunoassay. Components: goat anti-mouse IgG, mouse monoclonal anti-hCG, colloidal gold-conjugated monoclonal anti-hCG. Standardized to WHO 4th International Standard for Chorionic Gonadotropin. Formats: strip, cassette, midstream. No instrumentation required.

Indications for Use

Indicated for the qualitative determination of human chorionic gonadotropin (hCG) in human urine or serum to aid in the early detection of pregnancy. Available in strip, cassette, and midstream formats for professional clinical laboratory use or over-the-counter (OTC) use depending on format.

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 logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle. The logo is black and white.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AI DE Diagnostic, Co., Ltd. C-Tech c/o Lin Wang, 1929 Woodberry Court Iowa City, IA 52246

JUL 2 3 2007

Re: k062703

> Trade/Device Name: One Step HCG Urine Pregnancy Test Formats: Strip, Cassette and Midstream Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system. Regulatory Class: Class II Product Code: JHI, LCX Dated: June 07, 2007 Received: June 11, 2007

Dear Lin Wang:

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 1egally 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 yours.

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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## AIDE DIAGNOSTIC CO. LTI

141 Zhuzhou Road, Qingdao High-Tech Industrial Park, Shandong, P. R. China Tel : [phone] Fax : [phone]-mail : [e-mail]

### Statement of Indications for Use [21 CFR 801. 109]

#### 510 (K) Number: K062703

### Deice Trade Name: One Step HCG Urine Pregnancy Test Formats: Strip, Cassette and Midstream

### Indications for Use:

One Step HCG Urine Pregnancy Test is a rapid device, two sites sandwich immunoassay test device designed for the qualitative determination of human chorionic gonadotropin (hCG) concentration in human urine samples, and therefore is an aid in the early detection of pregnancy. These test devices are available in the formats of strip, cassette and midstream. The midstream format is intended for OTC use. The cassette and strip format are intended for both over-the counter (OTC) use and use in clinical laboratories.

Dean Cooper, D.V.M.
Division Sign-Off

Prescription Use X (Part 21 CFR 801 Subpart D) OR

Over-The-Counter Use X (Part 21 CFR 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 (OIVD)

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# AIDE DIAGNOSTIC CO. LTD

141 Zhuzhou Road, Qingdao High-Tech Industrial Park, Shandong, P. R. China Tel : [phone] Fax : [phone]E-mail : [e-mail]

## Statement of Indications for Use [21 CFR 801. 109]

JUL 2 3 2007

K062703 510 (K) Number:

### Deice Trade Name: One Step HCG Serum/Urine Combo Pregnancy Test Formats: Strip and Cassette

### Indications for Use:

One Step HCG Serum/Urine Combo Pregnancy Test is a rapid device, two sites sandwich immunoassay test device designed for the qualitative determination of human chorionic gonadotropin (hCG) concentration in human urine or serum samples, and therefore is an aid in the early detection of pregnancy. These test devices are available in strip format and cassette format, and are intended for in vitro diagnostic professional use in clinical laboratories only.

Sean Cooper, D.V.M
Division Sign-Off

610(k) Kole 27103

OR

Prescription Use X (Part 21 CFR 801 Subpart D) Over-The-Counter Use (Part 21 CFR 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 (OIVD)