PROOF POSITIVE ELECTRONIC PREGNANCY TEST

K043231 · Mizuho USA, Inc. · LCX · Apr 25, 2005 · Clinical Chemistry

Device Facts

• Record ID: K043231
• Device Name: PROOF POSITIVE ELECTRONIC PREGNANCY TEST
• Applicant: Mizuho USA, Inc.
• Product Code: LCX · Clinical Chemistry
• Decision Date: Apr 25, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

Proof Positive Electronic Pregnancy Test is an over-the-counter test for the qualitative determination of human chorionic gonadotropin (hCG) in urine, for the early detection of pregnancy.

Device Story

Proof Positive Electronic Pregnancy Test is an OTC lateral flow immunoassay for qualitative hCG detection in urine. Device utilizes mouse anti-hCG monoclonal antibodies conjugated to latex and colloidal gold particles. Urine sample flows through absorbent strip to reactive area; hCG binds to labeled antibody-dye conjugates forming antibody-antigen-antibody complexes. Onboard electronics detect complex formation and provide digital readout on LCD screen displaying 'Positive', 'Negative', or 'Positive Negative' with clock symbol. Intended for home use by consumers to determine pregnancy status. Results are available in 3 minutes. Benefits include simplified digital interpretation of test results compared to traditional colored-bar visual readouts.

Clinical Evidence

No clinical data provided in the document.

Technological Characteristics

Lateral flow immunoassay; solid-phase dye-conjugate. Components: mouse anti-hCG monoclonal antibodies, latex particles, colloidal gold particles, absorbent strip, onboard electronics, LCD display. Sensitivity: 50 mIU/mL. Traceability: WHO 3rd I.S. Standalone device; no external connectivity.

Indications for Use

Indicated for qualitative determination of hCG in urine for early pregnancy detection in the OTC market. Sensitivity is 50 mIU/mL.

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)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the border of the circle.

APR 2 5 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

k043231 Re:

Trade/Device Name: Proof Positive Electronic Pregnancy Test Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: LCX Dated: February 8, 2005 Received: March 18, 2005

Dear Mr. Zin:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the 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 r ou may, merersy mains of the Act include requirements for annual registration, listing of general controls profice, 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 r rease be actived a determination that your device complies with other requirements of the Act that + Diederal 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).

{1}------------------------------------------------

## Page 2 -

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,

Sean M. Cooper, MS, DUM

Jean M. Cooper, MS, 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

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known): K 043231

Proof Positive Electronic Pregnancy Test Device Name:

Indications For Use:

Proof Positive Electronic Pregnancy Test is an in-vitro diagnostic test for the Proof Positive determination of human chorionic godiadoropin (hCC) in urine, for the qualitative determination of numan chorions golder of 50 mIU/ml kCG in urine.

ﻴﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ

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

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)

Albert Satz
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k): K043231

Page 1 of