MULTI-USE ELECTRONIC PREGNANCY TEST

K060825 · Mizuho USA, Inc. · LCX · Jun 19, 2006 · Clinical Chemistry

Device Facts

• Record ID: K060825
• Device Name: MULTI-USE ELECTRONIC PREGNANCY TEST
• Applicant: Mizuho USA, Inc.
• Product Code: LCX · Clinical Chemistry
• Decision Date: Jun 19, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

Multi-Use Electronic Pregnancy Test is an in-vitro diagnostic test for the qualitative determination of human chorionic gonadotropin (hCG) in urine, for the early detection of pregnancy. The test will be marketed for the retail or "over-the-counter" (OTC) market use.

Device Story

Multi-Use Electronic Pregnancy Test is an OTC lateral flow immunoassay for hCG detection in urine. Device consists of a reusable electronic reader and disposable test cartridges containing antibody-conjugated latex and colloidal gold particles. User inserts cartridge into reader; applies urine to wick. hCG in urine binds to labeled antibody-dye conjugates, forming a complex that produces a colored band. Electronic reader measures reflectance at the test band to determine result. Reader provides qualitative positive/negative output via LED indicator. Internal process control monitors sample volume and wicking integrity; reader displays 'Invalid' if sample volume is insufficient/excessive, if test exceeds 10-minute activation window, or if device is damaged. Designed for home use by lay persons to facilitate early pregnancy detection.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and technological comparison to existing legally marketed devices.

Technological Characteristics

Solid-phase dye-conjugate lateral flow immunoassay. Components: mouse anti-hCG monoclonal antibody conjugated to latex and colloidal gold particles. Reader: electronic reflectance-based measurement with LED output. Power: battery-operated. Connectivity: none. Sterilization: not specified. Software: embedded firmware for reader functionality and result interpretation.

Indications for Use

Indicated for the qualitative detection of human chorionic gonadotropin (hCG) in urine for early pregnancy detection in the over-the-counter (OTC) retail market.

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 logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 19 2006

Benedict Zin President Mizuho USA, Inc. 12131 Community Road Poway, CA 92064

Re: k060825

Trade/Device Name: Multi-Use Electronic Pregnancy Test Regulation Number: 21 CFR§862.1155 Regulation Name: Human chorionic gonadotropin (HCG) Regulatory Class: Class II Product Code: LCX Dated: May 25, 2006 Received: June 1, 2006

Dear Mr. Zin:

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 10gally marketed predicate device results in a classification for your device and thus, percoits 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 Guti

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): K060825

Device Name:

Multi-Use Electronic Pregnancy Test

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Indications For Use:

Multi-Use Electronic Pregnancy Test is an in-vitro diagnostic test for the qualitative determination of human chorionic gonadotropin (hCG) in urine, for the early detection of pregnancy.

The test will be marketed for the retail or "over-the-counter" (OTC) market use.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

X Over-The-Counter Use (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)

CAC

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Office of In Vitro Diagnostic Device Evaluation and Safety