Cleared Traditional

K131110 - ONE STEP SINGLE/MULTI-DRUG TEST CUP

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

K131110 is an FDA 510(k) clearance for ONE STEP SINGLE/MULTI-DRUG TEST CUP, manufactured by Co-Innovation Biotech Co., Ltd.. The device is a Class 2 Toxicology device with product code DKZ cleared through the Traditional 510(k) pathway after a 271-day FDA review.

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

FDA 510(k) Submission Details - K131110

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
Combination Product No
PCCP Authorized No
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.

DKZ Device Classification - Class 2, Special Controls

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 208
Devices cleared under the same product code (DKZ) and FDA review panel - the closest regulatory comparables to K131110.
UCP MULTI-DRUG TEST KEY CUPS
K132812 · Ucp Biosciences, Inc. · Mar 2014
WONDFO MULTI-DRUG URINE TEST CUP, PANEL
K133968 · Guangzhou Wondfo Biotech Co., Ltd. · Feb 2014
LZI ORAL FLUID AMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS
K131653 · Lin-Zhi International, Inc. · Feb 2014
GENPRIME DRUGS OF ABUSE READER SYSTEM
K130082 · Genprime, Inc. · Dec 2013
INSTANT-VIEW MULTI-DRUG OF ABUSE URINE TEST (CUP, PANEL CASSETTE)
K131645 · Alfa Scientific Designs, Inc. · Oct 2013
UCP COMPACT DRUG TEST CARDS, UCP COMPACT DRUG TEST CUPS
K131811 · Ucp Biosciences, Inc. · Jul 2013