Cleared Traditional

K121557 - WONDFO CANNABINOIDS URINE TEST WONDFO PROPOXYPHENE URINE TEST

K121557 is an FDA 510(k) clearance for WONDFO CANNABINOIDS URINE TEST WONDFO P..., manufactured by Guangzhou Wondfo Biotech Co., Ltd.. The device is a Class 2 Chemistry device with product code LDJ cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K121557 · Guangzhou Wondfo Biotech Co., Ltd. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2012
Decision
61d
Days
Class 2
Risk

K121557 is an FDA 510(k) clearance for the WONDFO CANNABINOIDS URINE TEST WONDFO PROPOXYPHENE URINE TEST. Classified as Enzyme Immunoassay, Cannabinoids (product code LDJ), Class II - Special Controls.

Submitted by Guangzhou Wondfo Biotech Co., Ltd. (Gaithersburg, US). The FDA issued a Cleared decision on July 25, 2012 after a review of 61 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3870 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Guangzhou Wondfo Biotech Co., Ltd. devices

FDA 510(k) Submission Details - K121557

510(k) Number K121557 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 2012
Decision Date July 25, 2012
Days to Decision 61 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 88d · This submission: 61d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LDJ Device Classification - Class 2, Special Controls

Product Code LDJ Enzyme Immunoassay, Cannabinoids
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3870
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 Chemistry devices follow this clearance model.

Regulatory Peers - LDJ Enzyme Immunoassay, Cannabinoids

All 119
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