Cleared Traditional

K130055 - ACON BUP ONE STEP BUPRENORPHINE TEST STRIP

K130055 is the FDA 510(k) clearance for ACON BUP ONE STEP BUPRENORPHINE TEST STRIP by Guangzhou Wondfo Biotech Co., Ltd.. It is a Class 2 Toxicology device (product code DJG) cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K130055 · Guangzhou Wondfo Biotech Co., Ltd. · Toxicology device
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Feb 2013
Decision
36d
Days
Class 2
Risk

K130055 is an FDA 510(k) clearance for the ACON BUP ONE STEP BUPRENORPHINE TEST STRIP. 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 February 14, 2013 after a review of 36 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Guangzhou Wondfo Biotech Co., Ltd. devices

Submission Details

510(k) Number K130055 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 2013
Decision Date February 14, 2013
Days to Decision 36 days
Submission Type Traditional
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
51d faster than avg
Panel avg: 87d · This submission: 36d
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 Toxicology 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 K130055.
STATUS DS OXY
K130650 · Princeton BioMeditech Corp. · Feb 2014
IMMUNALYSIS OXYCODONE ENZYME IMMUNOASSAY
K131168 · Immunalysis Corporation · Jan 2014
WONDOFO MULTI-DRUG URINE TEST CUP / PANEL
K130665 · Guangzhou Wondfo Biotech Co., Ltd. · Apr 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 BUPRENORPHINE URINE TEST WONDFO OXYCODONE URINE TEST
K113624 · Guangzhou Wondfo Biotech Co., Ltd. · Mar 2012