Cleared Special

Clearblue® Early Detection Pregnancy Test (K240025) - FDA 510(k) Clearance

Class II Chemistry device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K240025 · Spd Swiss Precision Diagnostics GmbH · Chemistry device
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Jan 2024
Decision
28d
Days
Class 2
Risk

K240025 is an FDA 510(k) clearance for the Clearblue® Early Detection Pregnancy Test. Classified as Kit, Test, Pregnancy, Hcg, Over The Counter (product code LCX), Class II - Special Controls.

Submitted by Spd Swiss Precision Diagnostics GmbH (Geneva, CH). The FDA issued a Cleared decision on January 31, 2024 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1155 - the FDA in vitro diagnostics and chemistry framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Spd Swiss Precision Diagnostics GmbH devices

Submission Details

510(k) Number K240025 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2024
Decision Date January 31, 2024
Days to Decision 28 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 88d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LCX Kit, Test, Pregnancy, Hcg, Over The Counter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1155
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Consultant

SPD Development Company Limited
Kamila Przedmojska

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LCX Kit, Test, Pregnancy, Hcg, Over The Counter

All 49
Devices cleared under the same product code (LCX) and FDA review panel - the closest regulatory comparables to K240025.
HCG One Step Pregnancy Test Strip OTC, HCG One Step Pregnancy Test Strip Rx, HCG One Step Pregnancy Test Midstream OTC, HCG One Step Pregnancy Test Midstream Rx
K233624 · Hangzhou Aichek Medical Technology Co., Ltd. · Apr 2024
ACESO Early Pregnancy Test
K234152 · Aceso Laboratories, Inc. · Apr 2024
FaStep™ Pregnancy Rapid Test Strip
K233174 · Assure Tech. (Hangzhou) Co, Ltd. · Feb 2024
EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II
K232864 · Nantong Egens Biotechnology Co., Ltd. · Jan 2024
Macro & Micro-Test HCG Pregnancy Test Midstream
K230741 · Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. · Oct 2023
MissLan® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream)
K230038 · Guangzhou Decheng Biotechnology Co., Ltd. · Feb 2023