(79 days)
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Not Found
No
The summary describes a simple urine test for detecting LH surge, with no mention of AI, ML, image processing, or complex data analysis that would typically indicate the use of such technologies.
No
The device is an in vitro diagnostic test for predicting ovulation, which aids in conception but does not treat or alleviate a medical condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "an over-the-counter (OTC) in vitro diagnostic device".
No
The summary describes an in vitro diagnostic device that uses a urine test to detect LH surge. This indicates a physical test kit and not a software-only device.
Yes, based on the provided information, the CLEARPLAN EASY Ovulation Test is an IVD (In Vitro Diagnostic) device.
Here's why:
- Explicitly Stated: The "Intended Use / Indications for Use" section clearly states: "The CLEARPLAN EASY Ovulation Test, an over-the-counter (OTC) in vitro diagnostic device..."
- Method of Use: It is a urine test, which is a common method for in vitro diagnostics.
- Purpose: It is used to detect a substance (LH surge) in a biological sample (urine) to provide information about a physiological state (ovulation).
Therefore, the device fits the definition of an in vitro diagnostic device.
N/A
Intended Use / 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 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.
Product codes
CEP
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
women, over-the-counter through pharmacies and drug stores
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
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 (770) 488-7655.
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 (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" (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 (800) 638-2041 or (301) 443-6597 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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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)
O
(Division Sign-Off)
Division of Clinical Laboratory Devices
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