Cleared Special

K013372 - CLEARBLUE EASY EARLY RESULT PREGNANCY TEST

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

K013372 · Unipath , Ltd. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K013372

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
60d faster than avg
Panel avg: 89d · This submission: 29d
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 225
Devices cleared under the same product code (LCX) and FDA review panel - the closest regulatory comparables to K013372.
CLEARBLUE EASY EARLY RESULT PREGNANCY TEST
K023699 · Unipath , Ltd. · Nov 2002
AMEDITECH IMMUTEST HCG PREGANCY TEST
K023126 · Ameditech, Inc. · Nov 2002
INVERNESS MEDICAL EARLY PREGNANCY TEST
K013907 · Cambridge Diagnostics Ireland, Ltd. · Dec 2001
SURE CHECK PREGNANCY TEST
K011551 · Chembio Diagnostic Systems, Inc. · Aug 2001
QUIK-CHECK HOME PREGNANCY TEST
K012215 · ACON Laboratories, Inc. · Aug 2001
INVERNESS MEDICAL EARLY PREGNANCY TEST
K002049 · Selfcare, Inc. · Jul 2000
K013372 · CLEARBLUE EASY EARLY RESULT PREGNANCY TEST
Download PDF Unipath , Ltd.