Cleared Special

K151478 - Wondfo CR3 Keyless Split Sample Cup (FDA 510(k) Clearance)

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

K151478 · Guangzhou Wondfo Biotech Co., Ltd. · Toxicology device
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Optimized for regulatory review, auditing and printing
Jul 2015
Decision
29d
Days
Class 2
Risk

K151478 is an FDA 510(k) clearance for the Wondfo CR3 Keyless Split Sample Cup. Classified as Enzyme Immunoassay, Opiates (product code DJG), Class II - Special Controls.

Submitted by Guangzhou Wondfo Biotech Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on July 1, 2015 after a review of 29 days - a notably fast clearance 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Guangzhou Wondfo Biotech Co., Ltd. devices

Submission Details

510(k) Number K151478 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2015
Decision Date July 01, 2015
Days to Decision 29 days
Submission Type Special
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
58d faster than avg
Panel avg: 87d · This submission: 29d
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 Consultant

LSI International, Inc.
JOE SHIA

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DJG Enzyme Immunoassay, Opiates

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