Clearblue Easy Early Result Pregnancy Test

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K023699 ↗

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 Early Result Pregnancy Test used for?

  This test detects the presence of human chorionic gonadotropin (hCG) in urine, a hormone produced during pregnancy. It provides a visual result to confirm or rule out early pregnancy, typically within days of a missed period, for home use.

• How is the Clearblue Easy Early Result Pregnancy Test supplied and stored?

  The test is supplied as an over-the-counter diagnostic kit designed for single-use at home. It does not require refrigeration or special storage conditions beyond maintaining room temperature. Always check the packaging for expiration dates before use.

• Is the Clearblue Easy Early Result Pregnancy Test sterile or reusable?

  The test is not sterile and is intended for single-use only. It is not designed for reuse or clinical settings like hospitals or MRI environments. Each test should be used once and then discarded.

• Are there different sizes or models of the Clearblue Easy Early Result Pregnancy Test?

  The device is available in multiple lot or batch numbers (e.g., 3013332582, 3009238284), but these refer to regulatory or manufacturing identifiers rather than distinct sizes or models. The core design and functionality remain consistent across all versions.

• What regulatory approval does the Clearblue Easy Early Result Pregnancy Test hold?

  The test holds an FDA 510(k) clearance (K023699) under Special Review, classified as a Class II device. It is also filed under the FDA’s device type ‘Kit, Test, Pregnancy, HCG, Over The Counter.’ No additional regulatory approvals beyond this are referenced.