Cleared Special

K130665 - WONDOFO MULTI-DRUG URINE TEST CUP / PANEL

K130665 is an FDA 510(k) clearance for WONDOFO MULTI-DRUG URINE TEST CUP / PANEL, manufactured by Guangzhou Wondfo Biotech Co., Ltd.. The device is a Class 2 Toxicology device with product code DJG cleared through the Special 510(k) pathway after a 28-day FDA review.

K130665 · Guangzhou Wondfo Biotech Co., Ltd. · Toxicology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2013
Decision
28d
Days
Class 2
Risk

K130665 is an FDA 510(k) clearance for the WONDOFO MULTI-DRUG URINE TEST CUP / PANEL. 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 April 9, 2013 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3650 - 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.

FDA 510(k) Submission Details - K130665

510(k) Number K130665 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2013
Decision Date April 09, 2013
Days to Decision 28 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
59d faster than avg
Panel avg: 87d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

DJG Device Classification - Class 2, Special Controls

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 Toxicology devices follow this clearance model.

Regulatory Peers - DJG Enzyme Immunoassay, Opiates

All 214
Devices cleared under the same product code (DJG) and FDA review panel - the closest regulatory comparables to K130665.
IMMUNALYSIS OXYCODONE ENZYME IMMUNOASSAY
K131168 · Immunalysis Corporation · Jan 2014
QUIKSCREEN MULTI (MDMA AND OPI) OTC DRUG CUP TEST
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FORSURE ONE STEP BUPRENORPHINE CUP TEST DEVICE
K122064 · Tianjin New Bay Bioresearch Co., Ltd. · May 2013
ACON BUP ONE STEP BUPRENORPHINE TEST STRIP
K130055 · Guangzhou Wondfo Biotech Co., Ltd. · Feb 2013
PSYCHEMEDICS MICROPLATE EIA FOR OXYCODONE IN HAIR
K123799 · Psychemedics Corp. · Feb 2013
RANDOX OPIATES ASSAY
K113747 · Randox Laboratories Limited · Aug 2012
K130665 · WONDOFO MULTI-DRUG URINE TEST CUP / PANEL
Download PDF FDA Summary Guangzhou Wondfo Biot…