(90 days)
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.
Not Found
This is a 510(k) premarket notification for the CLEARPLAN EASY Ovulation Test, a luteinizing hormone test system. The device is intended for over-the-counter use by women as an aid to conception by predicting ovulation.
Because this is a 510(k) clearance letter, it only establishes substantial equivalence to a predicate device and does not contain acceptance criteria or study data. To obtain the detailed study information, you would typically need to refer to the full 510(k) submission available from the FDA or directly from the manufacturer.
Therefore, I cannot fulfill your request for the acceptance criteria and study details based solely on the provided document. The document confirms the FDA has reviewed the submission and determined that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.
Without the full 510(k) submission or supporting study documents, I cannot provide the specific details requested in your prompt regarding acceptance criteria, sample sizes, expert qualifications, and study methodologies.
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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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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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Page
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-0
Division ni ratory Devices
510(k) Nu. Ko13874
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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)
§ 862.1485 Luteinizing hormone test system.
(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.