Cleared Traditional

K050024 - ONE STEP MULTIPLE DRUGS OF ABUSE ASSAYS

K050024 is the FDA 510(k) clearance for ONE STEP MULTIPLE DRUGS OF ABUSE ASSAYS by Guangzhou Wondfo Biotech Co., Ltd.. It is a Class 2 Toxicology device (product code DIS) cleared through the Traditional 510(k) pathway after a 316-day FDA review.

K050024 · Guangzhou Wondfo Biotech Co., Ltd. · Toxicology device
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Nov 2005
Decision
316d
Days
Class 2
Risk

K050024 is an FDA 510(k) clearance for the ONE STEP MULTIPLE DRUGS OF ABUSE ASSAYS. Classified as Enzyme Immunoassay, Barbiturate (product code DIS), Class II - Special Controls.

Submitted by Guangzhou Wondfo Biotech Co., Ltd. (Yardley, US). The FDA issued a Cleared decision on November 17, 2005 after a review of 316 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3150 - 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 K050024 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 2005
Decision Date November 17, 2005
Days to Decision 316 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
229d slower than avg
Panel avg: 87d · This submission: 316d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DIS Enzyme Immunoassay, Barbiturate
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3150
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 - DIS Enzyme Immunoassay, Barbiturate

All 67
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