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.

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
Combination Product No
PCCP Authorized No
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 202
Devices cleared under the same product code (LCX) and FDA review panel - the closest regulatory comparables to K110433.
ATLAS HOME PREGNANCY TEST (MIDSTREAM FORMAT) MODEL 70172001
K102760 · Atlas Medical · Aug 2011
PREGNANCY ONE STEP RAPID TEST
K103574 · Lehnus & Associates Consulting · Jul 2011
IND ONE STEP HCG URINE PREGNANCY TEST (STRIP)
K110889 · Ind Diagnostics, Inc. · Jun 2011
RAPIDAN OPTIMA EARLY PREGNANCY TEST AND TOYO PREGNANCY TEST
K081150 · Turklab Medical Devices, Inc. · Jun 2009
FIRST RESPONSE EARLY RESULT PREGNANCY TEST (OTC)
K083716 · Church & Dwight Co., Inc. · Jun 2009
ONE STEP HCG URINE PREGNANCY TEST (STRIP), MODEL B01-S, ONE STEP HCG URINE PREGNANCY TEST (CASSETTE) , MODEL B01C
K071930 · Blue Cross Bio-Medical Co., Ltd. · Dec 2007
K110433 · CLEARBLUE EASY PREGNANCY TEST
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