CLEARPLANE EASY OVULATION TEST

K013874 · Unipath , Ltd. · CEP · Feb 19, 2002 · Clinical Chemistry

Device Facts

• Record ID: K013874
• Device Name: CLEARPLANE EASY OVULATION TEST
• Applicant: Unipath , Ltd.
• Product Code: CEP · Clinical Chemistry
• Decision Date: Feb 19, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1485
• Device Class: Class 1

Intended Use

The CLEARPLAN EASY Ovulation Test, an over-the-counter (OTC) in vitro diagnostic device, is a urine test for the detection of luteinizing hormone. It is intended to be used by women as an aid to conception by accurately and reliably predicting ovulation.

Device Story

CLEARPLAN EASY Ovulation Test is an OTC in vitro diagnostic device for home use. It detects luteinizing hormone (LH) in urine samples. The device provides a visual result to the user to predict the time of ovulation, thereby aiding in conception. The user performs the test and interprets the visual output to identify the LH surge, which indicates the most fertile period. This information assists the user in timing intercourse to maximize the probability of conception.

Clinical Evidence

No clinical data provided in the document; substantial equivalence is based on regulatory classification and intended use as an in vitro diagnostic device.

Technological Characteristics

In vitro diagnostic urine test for luteinizing hormone. Form factor is a test device for OTC use. No specific materials or software algorithms described.

Indications for Use

Indicated for women as an aid to conception by detecting luteinizing hormone in urine to predict ovulation. For over-the-counter use.

Regulatory Classification

Identification

A luteinizing hormone test system is a device intended to measure luteinizing hormone in serum and urine. Luteinizing hormone measurements are used in the diagnosis and treatment of gonadal dysfunction.

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 & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEB 1 9 2002

Ms. Louise Roberts Regulatory Affairs Manager Unipath Limited Priory Business Park Bedford MK 44 3UP United Kingdom

k013874 Re:

Trade/Device Name: CLEARPLAN EASY Ovulation Test Regulation Number: 21 CFR 862.1485 Regulation Name: Luteinizing hormone test system Regulatory Class: Class I reserved Product Code: CEP Dated: January 24, 2002 Received: January 28, 2002

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 for abound in the May 28, 1976, the enactment date of the Medical Device Amendments, or to conniner of the first to May 2017 , 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, atere, mans 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 11 your device to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 active and a tetermination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your 510(k) premarket I 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 advice for your device on our labeling regulation (21 CFR Part 801 and 1 11 you desire specific an revitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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 Butman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K013874

CLEARPLAN EASY Ovulation Test Device Name:

## Indications For Use:

The CLEARPLAN EASY Ovulation Test, an over-the-counter (OTC) in vitro diagnostic device, is a urine test for the detection of luteinizing hormone. It is intended to be used by women as an aid to conception by accurately and reliably predicting ovulation.

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Division ni ratory Devices
510(k) Nu. Ko13874

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Pcr 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)