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Clearblue Easy Pregnancy Test

by SPD Development Company Limited

510(k) K110433

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK110433 Date12 May 2011ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LCX
Device Class
Class II
Regulation
21 CFR Part 862.1155
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Clearblue Easy Pregnancy Test is a kit designed for the detection of human chorionic gonadotropin (hCG) in urine. This device is classified as an over-the-counter test used to determine pregnancy status.

This device is supplied as a single-use test kit and is regulated under FDA 510(k) authorization. It is intended for home use and falls under the clinical chemistry medical specialty.

Questions

AI-generated answers, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Clearblue Easy Pregnancy Test used for?

    This device is intended to determine pregnancy status by detecting the presence of human chorionic gonadotropin (hCG) in a urine sample.

  • Is this test kit intended for single or multiple uses?

    The Clearblue Easy Pregnancy Test is supplied as a single-use test kit, meaning each unit is designed to be used once to perform a single pregnancy test.

  • Where can this pregnancy test be used?

    This device is classified as an over-the-counter test intended for home use, allowing individuals to perform the test in a private, non-clinical setting.

  • How is this device regulated?

    The Clearblue Easy Pregnancy Test is regulated under FDA 510(k) authorization, which indicates it has been reviewed and found to be substantially equivalent to other legally marketed devices in the clinical chemistry specialty.