Cleared Traditional

K140215 - ONE STEP SINGLE/MULTI-DRUG TEST CUP/DIPCARD

K140215 is an FDA 510(k) clearance for ONE STEP SINGLE/MULTI-DRUG TEST CUP/DIPCARD, manufactured by Co-Innovation Biotech Co., Ltd.. The device is a Class 2 Toxicology device with product code DIS cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K140215 · Co-Innovation Biotech Co., Ltd. · Toxicology device
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Jun 2014
Decision
139d
Days
Class 2
Risk

K140215 is an FDA 510(k) clearance for the ONE STEP SINGLE/MULTI-DRUG TEST CUP/DIPCARD. Classified as Enzyme Immunoassay, Barbiturate (product code DIS), Class II - Special Controls.

Submitted by Co-Innovation Biotech Co., Ltd. (Guangzhou, Guangdong, CN). The FDA issued a Cleared decision on June 16, 2014 after a review of 139 days - within the typical 510(k) review window.

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. 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 - K140215

510(k) Number K140215 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 2014
Decision Date June 16, 2014
Days to Decision 139 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
52d slower than avg
Panel avg: 87d · This submission: 139d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DIS Device Classification - Class 2, Special Controls

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 94
Devices cleared under the same product code (DIS) and FDA review panel - the closest regulatory comparables to K140215.
Healgen Secobarbital Test(Strip, Cassette, Cup, Dip Card), Healgen Burprenorphine Test (Strip, Cassette, Cup, Dip Card), Healgen Methadone Test (Strip, Cassette, Cup, Dip Card)
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GenPrime Snap-Top Split Key Cup
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RANDOX BARITURATES ASSAY
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UCP DRUG SCREENING TEST CUPS
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AT HOME DRUG TEST MODELS, 9308T AND 9308X
K070009 · Phamatech, Inc. · Dec 2007