Cleared Special

K153050 - Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard (FDA 510(k) Clearance)

Class II Toxicology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K153050 · Co-Innovation Biotech Co., Ltd. · Toxicology device

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Apr 2016

Decision

189d

Days

Class 2

Risk

K153050 is an FDA 510(k) clearance for the Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard. Classified as Enzyme Immunoassay, Opiates (product code DJG), Class II - Special Controls.

Submitted by Co-Innovation Biotech Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on April 26, 2016 after a review of 189 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3650 - the FDA toxicology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Co-Innovation Biotech Co., Ltd. devices

Submission Details

510(k) Number	K153050 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 20, 2015
Decision Date	April 26, 2016
Days to Decision	189 days
Submission Type	Special
Review Panel	Toxicology (TX)
Summary	Summary PDF
Third-party Review	No - reviewed directly by FDA

Regulatory Context

Review time vs. panel average

102d slower than avg

Panel avg: 87d · This submission: 189d

Pathway characteristics

Modification to existing cleared device.

Device Classification

Product Code	DJG Enzyme Immunoassay, Opiates
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 862.3650

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.