Cleared Traditional

ONE STEP SINGLE/MULTI-DRUG TEST CUP (K131110) - FDA 510(k) Clearance

Also marketed or referenced as:
ONE STEP SINGLE SINGLE/MULTI-DRUG TEST DIPCARD

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

K131110 · Co-Innovation Biotech Co., Ltd. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2014
Decision
271d
Days
Class 2
Risk

K131110 is an FDA 510(k) clearance for the ONE STEP SINGLE/MULTI-DRUG TEST CUP. Classified as Enzyme Immunoassay, Amphetamine (product code DKZ), Class II - Special Controls.

Submitted by Co-Innovation Biotech Co., Ltd. (Guangzhou, Guangdong, CN). The FDA issued a Cleared decision on January 15, 2014 after a review of 271 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3100 - 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. Standard predicate reliance. 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 Co-Innovation Biotech Co., Ltd. devices

Submission Details

510(k) Number K131110 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 2013
Decision Date January 15, 2014
Days to Decision 271 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
184d slower than avg
Panel avg: 87d · This submission: 271d
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 Toxicology devices follow this clearance model.

Regulatory Peers - DKZ Enzyme Immunoassay, Amphetamine

All 78
Devices cleared under the same product code (DKZ) and FDA review panel - the closest regulatory comparables to K131110.
Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test Panel (Home Use)
K152122 · Alfa Scientific Designs, Inc. · Jun 2016
Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Cocaine Test (Strip, Cassette, Cup, Dip Card), Healgen Methamphetamine Test (Strip, Cassette, Cup, Dip Card)
K152269 · Healgen Scientific, LLC · Sep 2015
Immunalysis Amphetamine Urine Enzyme Immunoassay, Immunalysis Amphetamine Urine Calibrator, Immunalysis Amphetamine Urine Control Set
K143500 · Immunalysis Corporation · Feb 2015
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
RANDOX ECSTASY (MDMA) ASSAY
K092275 · Randox Laboratories, Ltd. · Mar 2011
AMPHETAMINES II ASSAY
K093664 · Roche Diagnostics Corp. · Jul 2010