Cleared Traditional

K111560 - WONDFO AMPHETAMINE URINE TEST

K111560 is the FDA 510(k) clearance for WONDFO AMPHETAMINE URINE TEST by Guangzhou Wondfo Biotech Co., Ltd.. It is a Class 2 Chemistry device (product code DKZ) cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K111560 · Guangzhou Wondfo Biotech Co., Ltd. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2011
Decision
42d
Days
Class 2
Risk

K111560 is an FDA 510(k) clearance for the WONDFO AMPHETAMINE URINE TEST, WONDFO BARBITURATES URINE TEST, WONDFO BENZODI.... Classified as Enzyme Immunoassay, Amphetamine (product code DKZ), Class II - Special Controls.

Submitted by Guangzhou Wondfo Biotech Co., Ltd. (Gaithersburg, US). The FDA issued a Cleared decision on July 15, 2011 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3100 - the FDA in vitro diagnostics and chemistry 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 K111560 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 2011
Decision Date July 15, 2011
Days to Decision 42 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 88d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DKZ Enzyme Immunoassay, Amphetamine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3100
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 Chemistry devices follow this clearance model.

Regulatory Peers - DKZ Enzyme Immunoassay, Amphetamine

All 124
Devices cleared under the same product code (DKZ) and FDA review panel - the closest regulatory comparables to K111560.
WONDFO AMPHETAMINE URINE TEST (AMP 300), WONDFO METHAMPHETAMINE URINE TEST (MET 500)
K122961 · Guangzhou Wondfo Biotech Co., Ltd. · Dec 2012
WONDFO MULTI-DRUG URINE TEST CUP MODEL W2002-CU
K122904 · Guangzhou Wondfo Biotech Co., Ltd. · Nov 2012
WONDFO AMPHETAMINE URINE TEST WONDFO BARBITURATES URINE TEST WONDFO BENZODIAZEPINES URINE TEST
K121987 · Guangzhou Wondfo Biotech Co., Ltd. · Aug 2012
ROCHE ORAL FLUID AMPHETAMINE, ROCHE ORAL FLUID DAT QUAL CAL B, ROCHE ORAL FLUID DAT CONTROL SET B, AND ROCHE ORAL FLUID
K110446 · Roche Diagnostics · May 2011
THERMO SCIENTIFIC CEDIA AMPHETAMINE OFT ASSAY
K101745 · Microgenics Corp. · Apr 2011
RANDOX ECSTASY (MDMA) ASSAY
K092275 · Randox Laboratories, Ltd. · Mar 2011