Cleared Traditional

K132630 - WONDFO OXAZEPAM URINE TEST (BZO 200) AND WONDFO METHAMPHETAMINE URINE TEST (MET 300) (FDA 510(k) Clearance)

Class II Toxicology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K132630 · Guangzhou Wondfo Biotech Co., Ltd. · Toxicology device
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Sep 2013
Decision
36d
Days
Class 2
Risk

K132630 is an FDA 510(k) clearance for the WONDFO OXAZEPAM URINE TEST (BZO 200) AND WONDFO METHAMPHETAMINE URINE TEST .... Classified as Thin Layer Chromatography, Methamphetamine (product code DJC), Class II - Special Controls.

Submitted by Guangzhou Wondfo Biotech Co., Ltd. (Gaithersburg, US). The FDA issued a Cleared decision on September 27, 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 862.3610 - 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 K132630 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 2013
Decision Date September 27, 2013
Days to Decision 36 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
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 DJC Thin Layer Chromatography, Methamphetamine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3610
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.