Cleared Traditional

K113624 - WONDFO BUPRENORPHINE URINE TEST WONDFO ...

K113624 is the FDA 510(k) clearance for WONDFO BUPRENORPHINE URINE TEST WONDFO ... by Guangzhou Wondfo Biotech Co., Ltd.. It is a Class 2 Chemistry device (product code DJG) cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K113624 · Guangzhou Wondfo Biotech Co., Ltd. · Chemistry device
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Mar 2012
Decision
95d
Days
Class 2
Risk

K113624 is an FDA 510(k) clearance for the WONDFO BUPRENORPHINE URINE TEST WONDFO OXYCODONE URINE TEST. Classified as Enzyme Immunoassay, Opiates (product code DJG), Class II - Special Controls.

Submitted by Guangzhou Wondfo Biotech Co., Ltd. (Gaithersburg, US). The FDA issued a Cleared decision on March 12, 2012 after a review of 95 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3650 - 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 K113624 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2011
Decision Date March 12, 2012
Days to Decision 95 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
7d slower than avg
Panel avg: 88d · This submission: 95d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DJG Enzyme Immunoassay, Opiates
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3650
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 - DJG Enzyme Immunoassay, Opiates

All 135
Devices cleared under the same product code (DJG) and FDA review panel - the closest regulatory comparables to K113624.
ACON BUP ONE STEP BUPRENORPHINE TEST STRIP
K130055 · Guangzhou Wondfo Biotech Co., Ltd. · Feb 2013
LZI OXYCODONE HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OXYCONDONE CALIBRATORS, LZI OXYCODONE CONTROLS
K120763 · Lin-Zhi International, Inc. · Jun 2012
LZI OPIATE 2000 HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OPIATE 2000 CALIBRATORS, LZI OPIATE 2000 CONTROLS
K120761 · Lin-Zhi International, Inc. · May 2012
WONDFO METHADONE URINE TEST,OPIATE TEST
K112310 · Guangzhou Wondfo Biotech Co., Ltd. · Sep 2011
OPIATE ENZYME IMMUNOASSAY
K110298 · Lin-Zhi International, Inc. · Jul 2011
THERMO SCIENTIFIC CEDIA OPIATE OFT ASSAY
K101754 · Microgenics Corp. · Apr 2011