Clearblue ® Early Pregnancy Test

FDA 510(k) K213379 · Spd Swiss Precision Diagnostics GmbH

Substantially Equivalent

510(k) numberK213379

Submission

Device name
Clearblue ® Early Pregnancy Test
Applicant
Spd Swiss Precision Diagnostics GmbH
Geneva, CH
Received
October 13, 2021
Decision date
September 21, 2022
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LCX – Kit, Test, Pregnancy, Hcg, Over The Counter
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1155
Specialty
Clinical Chemistry

Other 510(k)s with product code LCX

510(k)DeviceApplicantDecision
K251040MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy…LCX · Traditional Guangzhou Decheng Biotechnology Co., Ltd.09/09/2025SE
K251053Shinetell PlusTM Digital Early Pregnancy TestLCX · Traditional Hangzhou AllTest Biotech Co., Ltd.07/15/2025SE
K250117FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test CassetteLCX · Traditional Assure Tech., LLC02/13/2025SE
K242135Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene…LCX · Traditional Nanjing Synthgene Medical Technology Co., Ltd.01/31/2025SE
K243573FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette…LCX · Traditional Assure Tech., LLC01/15/2025SE
K241394iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test StripLCX · Traditional Andon Health Co, Ltd.12/20/2024SE
K240242HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Cassette…LCX · Traditional Anhui Deepblue Medical Technology Co., Ltd.10/11/2024SE
K241978Shinetell Digital Pregnancy TestLCX · Traditional Hangzhou AllTest Biotech Co., Ltd.08/13/2024SE
K240643MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test…LCX · Traditional Guangzhou Decheng Biotechnology Co., Ltd.06/21/2024SE
K232715Distinct® Digital Pregnancy TestLCX · Traditional ACON Laboratories, Inc.05/31/2024SE

More from ACON Laboratories, Inc.

510(k)DeviceDecision
K240025Clearblue® Early Detection Pregnancy TestLCX · Special 01/31/2024SE
K210341One Step Pregnancy TestLCX · Traditional 03/10/2022SE
K200913Clearblue® Early Digital Pregnancy TestLCX · Traditional 08/13/2021SE

Questions and answers

When was Clearblue ® Early Pregnancy Test cleared by the FDA?

Clearblue ® Early Pregnancy Test (K213379) received a 510(k) decision of Substantially Equivalent on September 21, 2022, 343 days after the submission was received.

What is the product code of K213379?

The FDA product code is LCX – Kit, Test, Pregnancy, Hcg, Over The Counter, a Class II (moderate risk) device regulated under 21 CFR 862.1155.