Clearblue Easy

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K905742 ↗

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

• Clearblue Easy

  Class II

  FDA 510(k) K911566 Active Cleared 6 May 1991

• Immunoglobulins G

  Class II

  FDA 510(k) K873870 Active Cleared 13 Oct 1987

• Cefepine Antimicrobial Susceptibility Test Disc

  Class II

  FDA 510(k) K964495 Active Cleared 7 Feb 1997

• Turbox Fibrinogen

  Class II

  FDA 510(k) K884179 Active Cleared 20 Dec 1988

• Clearblue Easy Earliest Results Pregnancy Test

  Class II

  FDA 510(k) K040341 Active Cleared 8 Mar 2004

• Cell-Dyn 3000A Multi-Parameter Auto Hema Analzyer

  Class II

  FDA 510(k) K913305 Active Cleared 22 Nov 1991

See all devices from Unipath, Ltd. →

• What is the Clearblue Easy pregnancy test kit used for?

  The Clearblue Easy is designed to detect the presence of human chorionic gonadotropin (hCG) in urine, a hormone produced during pregnancy. It provides a qualitative result indicating whether hCG is present, helping users determine if they are pregnant. This test is intended for home use and does not require medical training or equipment.

• How is the Clearblue Easy pregnancy test kit supplied?

  The Clearblue Easy is supplied as a single-use, cassette-style device. It is intended for one-time use per test and comes in a format that does not require any additional equipment or preparation beyond following the included instructions. Each test is individually packaged for convenience and hygiene.

• Is the Clearblue Easy test sterile?

  The Clearblue Easy is designed for single-use and is intended to be used in a clean environment, typically at home. While the device itself is not explicitly described as sterile in a medical sense (like a surgical instrument), it is packaged to maintain integrity and prevent contamination before use. Users should follow storage instructions to ensure the test remains effective.

• Can the Clearblue Easy test be reused?

  No, the Clearblue Easy is explicitly designed as a single-use device. Reusing it could compromise accuracy and hygiene, as the test relies on detecting hCG in urine collected at a specific time. Each test should only be used once, per the manufacturer’s guidelines.

• How should the Clearblue Easy be stored?

  The Clearblue Easy should be stored according to the manufacturer’s instructions, typically at room temperature. It should be kept away from direct sunlight, moisture, and extreme temperatures to maintain its effectiveness. Proper storage ensures the test remains accurate and reliable when used.