Cleared Traditional

K130055 - ACON BUP ONE STEP BUPRENORPHINE TEST STRIP

K130055 is an FDA 510(k) clearance for ACON BUP ONE STEP BUPRENORPHINE TEST STRIP, manufactured by Guangzhou Wondfo Biotech Co., Ltd.. The device is a Class 2 Toxicology device with 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

FDA 510(k) Submission Details - K130055

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.

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 177
Devices cleared under the same product code (DJG) and FDA review panel - the closest regulatory comparables to K130055.
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RANDOX OPIATES ASSAY
K113747 · Randox Laboratories Limited · Aug 2012
LZI OXYCODONE HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OXYCONDONE CALIBRATORS, LZI OXYCODONE CONTROLS
K120763 · Lin-Zhi International, Inc. · Jun 2012