EPT CERTAINTY PREGNANCY TEST

K032939 · Unipath , Ltd. · LCX · Oct 20, 2003 · Clinical Chemistry

Device Facts

• Record ID: K032939
• Device Name: EPT CERTAINTY PREGNANCY TEST
• Applicant: Unipath , Ltd.
• Product Code: LCX · Clinical Chemistry
• Decision Date: Oct 20, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

EPT Certainty" M Pregnancy Test is an over-the-counter urine hCG test which is intended for the detection of pregnancy. The test has a sensitivity of 50mIU/ml hCG in urine, and can be used from the first day of the missed period.

Device Story

EPT Certainty™ Pregnancy Test; modified version of previously cleared device. Modifications limited to brand name, color, and reader aesthetics/cosmetic changes for brand consistency. Labeling updated to reflect design changes and own-labeler identity. Device functions as pregnancy test; intended use remains unchanged from predicate. Operated by consumer for home use.

Clinical Evidence

No clinical data; bench testing and design control verification/validation activities performed to confirm modifications did not impact device performance.

Technological Characteristics

Pregnancy test device; modifications limited to aesthetic/cosmetic design and branding. Fundamental scientific technology unchanged from predicate. No changes to sensing principle or materials.

Indications for Use

Indicated for the detection of pregnancy in urine for over-the-counter use by individuals starting from the first day of a missed period.

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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines forming its wings and body. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

OCT 2 0 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Louise Roberts Regulatory Affairs Manager Unipath Ltd. Priory Business Park Bedford MK44 3UP, UK

Re: k032939

> Trade/Device Name: EPT Certainty™ Pregnancy Test Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: LCX Dated: September 12, 2003 Received: September 22, 2003

Dear Ms. Roberts:

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 (OS) 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/dsma/dsmamain.html.

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K032939

Device Name: EPT Certainty™ Pregnancy Test

Indications For Use:

EPT Certainty" M Pregnancy Test is an over-the-counter urine hCG test which is intended for the detection of pregnancy. The test has a sensitivity of 50mIU/ml hCG in urine, and can be used from the first day of the missed period.

Whate Suli's

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**Division Sign-Off** for Jaun Cooper

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K032939

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109) ાર

Over-The-Counter Use

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