Cleared Traditional

K150022 - Wondfo One Step HCG Urine Pregnancy Tes...

K150022 is the FDA 510(k) clearance for Wondfo One Step HCG Urine Pregnancy Tes... 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 213-day FDA review.

K150022 · Guangzhou Wondfo Biotech Co., Ltd. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2015
Decision
213d
Days
Class 2
Risk

K150022 is an FDA 510(k) clearance for the Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pre.... Classified as Kit, Test, Pregnancy, Hcg, Over The Counter (product code LCX), Class II - Special Controls.

Submitted by Guangzhou Wondfo Biotech Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on August 7, 2015 after a review of 213 days - an extended review cycle.

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 K150022 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 2015
Decision Date August 07, 2015
Days to Decision 213 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
125d slower than avg
Panel avg: 88d · This submission: 213d
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 Consultant

LSI International, Inc.
Joe Shia

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K150022.
David Home Pregnancy Test Cassette, David Professional Pregnancy Test Cassette
K172627 · Runbio Biotech Co.,Ltd · Mar 2018
Preview Digital Pregnancy Test
K173229 · Guangzhou Wondfo Biotech Co., Ltd. · Mar 2018
ACRO HCG Pregnancy Rapid Test
K172512 · Acro Biotech, Inc. · Feb 2018
FORA PNC100 DIGITAL PREGANCY TEST, TD-5301 PREGANCY TEST
K103487 · Taidoc Technology Corporation · Oct 2011
E.P.T. CERTAINTY 1-STEP PREGNANCY TEST
K061769 · Unipath , Ltd. · Jul 2006
CLEARBLUE EASY DIGITAL PREGNANCY TEST
K060128 · Unipath , Ltd. · May 2006