Cleared Special

K122904 - WONDFO MULTI-DRUG URINE TEST CUP MODEL ...

Also marketed or referenced as:
W2003-CU W2004-CU W2005-CU W2006-CU W2007-CU W2008-CU W2009-CU

K122904 is the FDA 510(k) clearance for WONDFO MULTI-DRUG URINE TEST CUP MODEL ... by Guangzhou Wondfo Biotech Co., Ltd.. It is a Class 2 Toxicology device (product code DKZ) cleared through the Special 510(k) pathway after a 55-day FDA review.

K122904 · Guangzhou Wondfo Biotech Co., Ltd. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2012
Decision
55d
Days
Class 2
Risk

K122904 is an FDA 510(k) clearance for the WONDFO MULTI-DRUG URINE TEST CUP MODEL W2002-CU. Classified as Enzyme Immunoassay, Amphetamine (product code DKZ), Class II - Special Controls.

Submitted by Guangzhou Wondfo Biotech Co., Ltd. (Gaithersburg, US). The FDA issued a Cleared decision on November 15, 2012 after a review of 55 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3100 - the FDA toxicology device 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 Guangzhou Wondfo Biotech Co., Ltd. devices

Submission Details

510(k) Number K122904 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2012
Decision Date November 15, 2012
Days to Decision 55 days
Submission Type Special
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 87d · This submission: 55d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DKZ Enzyme Immunoassay, Amphetamine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3100
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 Toxicology devices follow this clearance model.

Regulatory Peers - DKZ Enzyme Immunoassay, Amphetamine

All 124
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K111560 · Guangzhou Wondfo Biotech Co., Ltd. · Jul 2011
ROCHE ORAL FLUID AMPHETAMINE, ROCHE ORAL FLUID DAT QUAL CAL B, ROCHE ORAL FLUID DAT CONTROL SET B, AND ROCHE ORAL FLUID
K110446 · Roche Diagnostics · May 2011