CLEARPLAN EASY OVULATION TEST

K981271 · Unipath , Ltd. · CEP · Jun 25, 1998 · Clinical Chemistry

Device Facts

• Record ID: K981271
• Device Name: CLEARPLAN EASY OVULATION TEST
• Applicant: Unipath , Ltd.
• Product Code: CEP · Clinical Chemistry
• Decision Date: Jun 25, 1998
• 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 intended to be used by women as an aid to conception by accurately and reliably predicting ovulation via a urine test. The CLEARPLAN EASY Ovulation Test detects the LH surge in a woman's urine. The product will be made available over-the-counter through pharmacies and drug stores.

Device Story

Clearplan Easy Ovulation Test is an OTC in vitro diagnostic device for home use. It detects the LH surge in a woman's urine to predict ovulation, aiding in conception. The user performs the test by applying urine to the device; the device provides a visual result indicating the presence or absence of the LH surge. This information helps the user identify their most fertile days, facilitating clinical decision-making regarding the timing of intercourse to improve the likelihood of conception.

Clinical Evidence

No clinical data provided in the document.

Technological Characteristics

In vitro diagnostic test for LH surge detection in urine; OTC format; visual readout; lateral flow immunoassay principle.

Indications for Use

Indicated for women desiring to conceive; used as an aid to predict ovulation by detecting the luteinizing hormone (LH) surge in urine.

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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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 25 1998

Louise Roberts . Requlatory Affairs Manager UniPath Limited Priory Business Park Bedford, MK44 3UP United Kingdom

K981271 Re : Clearplan Easy Ovulation Test Regulatory Class: । Product Code: CEP June 4, 1998 Dated: Received: June 8, 1998

Dear Ms. Roberts:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਕੇ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Reqister. this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Steven Bitman

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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K981271 510(k) Number (if known):_

CLEARPLAN EASY OVULATION TEST Device Name:

Indications For Use:

The CLEARPLAN EASY Ovulation Test, an over-the-counter (OTC) in vitro diagnostic device, is intended to be used by women as an aid to conception by The CLEARPLAN accurately and reliably predicting ovulation via a urine test. EASY Ovulation Test detects the LH surge in a woman's urine. The product will be made available over-the-counter through pharmacies and drug stores.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) ાર

510(k) Number _

Over-The-Counter Use √

(Optional Format 1-2-96)

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(Division Sign-Off)
Division of Clinical Laboratory Devices

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