Cleared Traditional

K093175 - WONDFO ONE STEP BUPRENORPHINE URINE TEST

K093175 is the FDA 510(k) clearance for WONDFO ONE STEP BUPRENORPHINE URINE TEST 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 321-day FDA review.

K093175 · Guangzhou Wondfo Biotech Co., Ltd. · Toxicology device
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Aug 2010
Decision
321d
Days
Class 2
Risk

K093175 is an FDA 510(k) clearance for the WONDFO ONE STEP BUPRENORPHINE URINE TEST, OXYCODONE URINE TEST, PROPOXPHENE U.... Classified as Enzyme Immunoassay, Opiates (product code DJG), Class II - Special Controls.

Submitted by Guangzhou Wondfo Biotech Co., Ltd. (Greenville, US). The FDA issued a Cleared decision on August 25, 2010 after a review of 321 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Toxicology 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 K093175 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 2009
Decision Date August 25, 2010
Days to Decision 321 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
234d slower than avg
Panel avg: 87d · This submission: 321d
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 136
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K090844 · Lin-Zhi International, Inc. · Jul 2009