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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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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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