Search Results

CLEARBLUE EASY is an over-the-counter urine hCG test which is intended for the detection of preguancy. The test has a sensitivity of 50mIU/ml hCG in urine, and is indicated for use from four days before the first day of the missed period.

Not Found

This document is a 510(k) clearance letter from the FDA for a pregnancy test, not a study describing acceptance criteria or performance data for an AI/ML device. Therefore, I cannot extract the requested information. The letter confirms substantial equivalence to a predicate device and states the indications for use, but does not contain performance study details typically associated with AI/ML device evaluations.

Ask a specific question about this device

CLEARBLUE EASY is an over-the-counter urine hCG test which is intended for the detection of pregnancy. The test has a sensitivity of 50mlU/ml hCG in urine, and is indicated for use from four days before the expected missed period.

Not Found

The provided text is a 510(k) premarket notification approval letter for the Clear Blue Easy™ Early Result Pregnancy Test. It acknowledges the device's substantial equivalence to previously marketed predicate devices. However, this document does not contain the details required to answer your specific questions about acceptance criteria, study methodologies, sample sizes, expert qualifications, or ground truth establishment.

The letter focuses on regulatory approval based on substantial equivalence and general controls, rather than on a detailed scientific study report.

Therefore, I cannot provide the requested information based solely on the text provided. To answer your questions, I would need access to the actual 510(k) submission document (K013372) which would outline the performance data and testing conducted by Unilever United States, Inc.

Ask a specific question about this device