PURE-AID PREGNANCY TEST

K053452 · Bio Focus Co., Lt. · LCX · May 25, 2006 · Clinical Chemistry

Device Facts

• Record ID: K053452
• Device Name: PURE-AID PREGNANCY TEST
• Applicant: Bio Focus Co., Lt.
• Product Code: LCX · Clinical Chemistry
• Decision Date: May 25, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

Pure-Aid Pregnancy Test is intended for the qualitative determination of human chorionic gonadotropin (hCG) in human urine. The test is for Over-the-Counter use. The test is for the early detection of pregnancy.

Device Story

Single-use lateral flow chromatographic immunoassay; detects hCG in human urine. User places absorbent tip in urine stream or dips into collected sample. Capillary action moves urine along membrane; hCG binds to mouse monoclonal antibody-dye conjugate. Colored line appears in test window if hCG present (≥25 mIU/mL); control line confirms proper wicking. Used by lay persons in home setting. Results interpreted visually by user. Provides early pregnancy detection; aids in clinical decision-making regarding pregnancy status.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Lateral flow immunoassay for qualitative hCG detection in urine. Device is a single-use, over-the-counter diagnostic test. No electronic components, software, or external power source required.

Indications for Use

Indicated for the qualitative detection of hCG in human urine for the early detection of pregnancy in individuals using the device in an over-the-counter setting.

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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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 caduceus, a symbol often associated with medicine and healthcare, on the right side. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the caduceus. The seal is presented in black and white.

## Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 2 5 2006

Bio Focus Co., Lt. c/o Ms. Lauren E. Hong General Manager Kareway Product, Inc. 15141 S. Figueroa St. Los Angeles, CA 90248

Re: k053452

> Trade/Device Name; Pure-Aid 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 20, 2006 Received: April 21, 2006

Dear Ms. Hong:

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

Sincerely yours.

Alberto G.

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 (if known): k053452

Device Name: Pure-Aid Pregnancy Test

Indications For Use:

Pure-Aid Pregnancy Test is intended for the qualitative determination of Human Chorionic Gonadotropin (hCG) in Human urine. The test is for Over-The-Counter use. The test is for the early detection of pregnancy.

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

Over-The-Counter Use X (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 Devices (OIVD)

Carol C. Benson
Division Sign

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