Cleared Special

K110433 - CLEARBLUE EASY PREGNANCY TEST

K110433 is an FDA 510(k) clearance for CLEARBLUE EASY PREGNANCY TEST, manufactured by SPD Development Company Limited. The device is a Class 2 Chemistry device with product code LCX cleared through the Special 510(k) pathway after a 86-day FDA review.

K110433 · SPD Development Company Limited · Chemistry device
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May 2011
Decision
86d
Days
Class 2
Risk

K110433 is an FDA 510(k) clearance for the CLEARBLUE EASY PREGNANCY TEST. Classified as Kit, Test, Pregnancy, Hcg, Over The Counter (product code LCX), Class II - Special Controls.

Submitted by SPD Development Company Limited (Bedford, Bedfordshire, GB). The FDA issued a Cleared decision on May 12, 2011 after a review of 86 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 Development Company Limited devices

FDA 510(k) Submission Details - K110433

510(k) Number K110433 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 2011
Decision Date May 12, 2011
Days to Decision 86 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 88d · This submission: 86d
Pathway characteristics
Modification to existing cleared device.

LCX Device Classification - Class 2, Special Controls

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

All 135
Devices cleared under the same product code (LCX) and FDA review panel - the closest regulatory comparables to K110433.
FIRST RESPONSE EARLY RESULT PREGNANCY TEST
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K123703 · Healgen Scientific, LLC · Apr 2013
FORA PNC100 DIGITAL PREGANCY TEST, TD-5301 PREGANCY TEST
K103487 · Taidoc Technology Corporation · Oct 2011
FIRST RESPONSE EARLY RESULT PREGNANCY TEST (OTC)
K083716 · Church & Dwight Co., Inc. · Jun 2009
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K070054 · Church & Dwight Co., Inc. · May 2007
E.P.T. CERTAINTY 1-STEP PREGNANCY TEST
K061769 · Unipath , Ltd. · Jul 2006