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The CLEARPLAN EASY II Home Pregnancy Test, an over-the-counter (OTC) in vitro diagnostic device, is intended to be used by women to detect pregnancy via a urine test. The CLEARPLAN EASY II Home Pregnancy Test is a qualitative test which detects the hormone human chorionic gonadotrophin (hCG) in urine.

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This document is a letter from the FDA regarding a Clearplan Easy II Home Pregnancy Test. It is a 510(k) clearance letter, confirming that the device is substantially equivalent to a legally marketed predicate device. As such, it does not contain a detailed study report with acceptance criteria and performance data in the format requested.

The letter primarily covers the regulatory approval of the device. It states the indications for use, regulatory class, product code, and clarifies that the device can be marketed. It also mentions compliance with general controls, such as annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

Therefore, I cannot provide the requested information (points 1-9) as it is not present in the provided FDA 510(k) clearance letter.

A 510(k) clearance document typically summarizes that a device has met the requirements for substantial equivalence, often referencing specific studies submitted by the manufacturer. However, the clearance letter itself does not usually detail the full study methodology, exact acceptance criteria, device performance, and other specifics of the underlying studies. Those details would be found in the original submission by Unipath Limited, which is not provided here.

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