Cleared Special

K013372 - CLEARBLUE EASY EARLY RESULT PREGNANCY TEST

K013372 is the FDA 510(k) clearance for CLEARBLUE EASY EARLY RESULT PREGNANCY TEST by Unipath , Ltd.. It is a Class 2 Chemistry device (product code LCX) cleared through the Special 510(k) pathway after a 29-day FDA review.

K013372 · Unipath , Ltd. · Chemistry device
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Nov 2001
Decision
29d
Days
Class 2
Risk

K013372 is an FDA 510(k) clearance for the CLEARBLUE EASY EARLY RESULT PREGNANCY TEST. Classified as Kit, Test, Pregnancy, Hcg, Over The Counter (product code LCX), Class II - Special Controls.

Submitted by Unipath , Ltd. (New York, US). The FDA issued a Cleared decision on November 9, 2001 after a review of 29 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 Unipath , Ltd. devices

Submission Details

510(k) Number K013372 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 2001
Decision Date November 09, 2001
Days to Decision 29 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
59d faster than avg
Panel avg: 88d · This submission: 29d
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 Peers - LCX Kit, Test, Pregnancy, Hcg, Over The Counter

All 111
Devices cleared under the same product code (LCX) and FDA review panel - the closest regulatory comparables to K013372.
CLEARBLUE EASY DIGITAL PREGNANCY TEST
K030659 · Unipath , Ltd. · May 2003
FIRST RESPONSE PREGNANCY TEST
K030258 · Armkel, LLC · Feb 2003
CLEARBLUE EASY EARLY RESULT PREGNANCY TEST
K023699 · Unipath , Ltd. · Nov 2002
QUIK-CHECK HOME PREGNANCY TEST
K012215 · ACON Laboratories, Inc. · Aug 2001
ACON ONE STEP HOME PREGNANCY TEST STRIP
K993483 · ACON Laboratories, Inc. · Jan 2000
FIRST RESPONSE 1-STEP PREGNANCY
K992232 · Armkel, LLC · Dec 1999