Cleared Special

K042280 - FACT PLUS ONE-STEP PREGNANCY TEST KIT

K042280 is an FDA 510(k) clearance for FACT PLUS ONE-STEP PREGNANCY TEST KIT, 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 18-day FDA review.

K042280 · Unipath , Ltd. · Chemistry device
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Sep 2004
Decision
18d
Days
Class 2
Risk

K042280 is an FDA 510(k) clearance for the FACT PLUS ONE-STEP PREGNANCY TEST KIT. Classified as Kit, Test, Pregnancy, Hcg, Over The Counter (product code LCX), Class II - Special Controls.

Submitted by Unipath , Ltd. (Bedford, GB). The FDA issued a Cleared decision on September 10, 2004 after a review of 18 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 - K042280

510(k) Number K042280 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2004
Decision Date September 10, 2004
Days to Decision 18 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
71d faster than avg
Panel avg: 89d · This submission: 18d
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 K042280.
PROOF POSITIVE ELECTRONIC PREGNANCY TEST
K043231 · Mizuho USA, Inc. · Apr 2005
ONE STEP HCG URINE PREGNANCY TEST
K043443 · Guangzhou Wondfo Biotech Co., Ltd. · Apr 2005
FIRST RESPONSE ONE-STEP DIGITAL PREGNANCY TEST
K040866 · Armkel, LLC · Oct 2004
ACON SPECTRUM HCG MIDSTREAM PREGNANCY TEST
K042151 · ACON Laboratories, Inc. · Sep 2004
AZOG, INC. HCG ONE-STEP URINE HOME PREGNANCY TEST (DIP STICK, CASSETTE AND MIDSTREAM)
K041748 · Azog, Inc. · Aug 2004
CLEARBLUE EASY EASY READ PREGNANCY TEST
K041404 · Unipath , Ltd. · Jun 2004
K042280 · FACT PLUS ONE-STEP PREGNANCY TEST KIT
Download PDF Unipath , Ltd.