Cleared Traditional

K043443 - ONE STEP HCG URINE PREGNANCY TEST

K043443 is the FDA 510(k) clearance for ONE STEP HCG URINE PREGNANCY TEST by Guangzhou Wondfo Biotech Co., Ltd.. It is a Class 2 Chemistry device (product code LCX) cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K043443 · Guangzhou Wondfo Biotech Co., Ltd. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2005
Decision
115d
Days
Class 2
Risk

K043443 is an FDA 510(k) clearance for the ONE STEP HCG URINE PREGNANCY TEST. Classified as Kit, Test, Pregnancy, Hcg, Over The Counter (product code LCX), Class II - Special Controls.

Submitted by Guangzhou Wondfo Biotech Co., Ltd. (Yardley, US). The FDA issued a Cleared decision on April 8, 2005 after a review of 115 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1155 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Guangzhou Wondfo Biotech Co., Ltd. devices

Submission Details

510(k) Number K043443 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 2004
Decision Date April 08, 2005
Days to Decision 115 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d slower than avg
Panel avg: 88d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K043443.
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E.P.T. CERTAINTY PREGNANCY TEST
K050930 · Unipath , Ltd. · May 2005
FIRST RESPONSE ONE-STEP DIGITAL PREGNANCY TEST
K040866 · Armkel, LLC · Oct 2004
FACT PLUS ONE-STEP PREGNANCY TEST KIT
K042280 · Unipath , Ltd. · Sep 2004
ACON SPECTRUM HCG MIDSTREAM PREGNANCY TEST
K042151 · ACON Laboratories, Inc. · Sep 2004