Clearblue Easy

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K911566 ↗

FDA Product Code

LCX

FDA applicant

Unipath , Ltd.

Device Class

Class II

Regulation

21 CFR Part 862.1155

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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See all devices from Unipath, Ltd. →

• What is the Clearblue Easy Digital Pregnancy Test used for?

  The Clearblue Easy Digital Pregnancy Test is designed to detect the presence of human chorionic gonadotropin (hCG) in urine, confirming pregnancy status. It provides a clear, unambiguous digital result—either ‘Pregnant’ or ‘Not Pregnant’—for at-home use. The test is intended for early detection, starting from four days before the expected menstrual period, allowing users to confirm pregnancy before a missed period.

• How is the Clearblue Easy Digital Pregnancy Test supplied, and is it sterile?

  The Clearblue Easy Digital Pregnancy Test is supplied as a single-use, non-sterile device for home diagnostic use. It is packaged individually to ensure usability in an at-home setting without requiring professional handling or sterile conditions. The non-sterile classification means it is not intended for invasive procedures or clinical environments where sterility is critical.

• Is the Clearblue Easy Digital Pregnancy Test reusable, and what sizes or models are available?

  The Clearblue Easy Digital Pregnancy Test is a single-use device, meaning each test is designed for one-time use only. There are no reusable components or interchangeable parts. The device does not specify multiple sizes or models in its regulatory data; it is a standardized, single-format test for home use.

• What are the storage requirements for the Clearblue Easy Digital Pregnancy Test?

  The regulatory data for the Clearblue Easy Digital Pregnancy Test does not specify any particular storage conditions, such as temperature or humidity requirements. However, as with most medical devices, it is generally recommended to store the test in a cool, dry place, away from direct sunlight and moisture, to maintain its integrity until use.

• What regulatory pathway was followed for the Clearblue Easy Digital Pregnancy Test, and what class is it?

  The Clearblue Easy Digital Pregnancy Test is classified as a Class 2 medical device under FDA regulations, with the product code LCX. It was cleared via the Traditional 510(k) pathway, which means it was determined to be substantially equivalent to a legally marketed device already on the market. The device carries FDA 510(k) clearances (K030659 and K060128) and is intended for over-the-counter home use without professional supervision.