Cleared Special

Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard (K153050) - 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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Optimized for regulatory review, auditing and printing
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.

Regulatory Peers - DJG Enzyme Immunoassay, Opiates

All 89
Devices cleared under the same product code (DJG) and FDA review panel - the closest regulatory comparables to K153050.
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K143502 · Immunalysis Corporation · May 2015