Cleared Traditional

Wondfo Propoxyphene Urine Test (K152495) - FDA 510(k) Clearance

Class II Toxicology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K152495 · Guangzhou Wondfo Biotech Co., Ltd. · Toxicology device
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Nov 2015
Decision
83d
Days
Class 2
Risk

K152495 is an FDA 510(k) clearance for the Wondfo Propoxyphene Urine Test. Classified as Enzyme Immunoassay, Propoxyphene (product code JXN), Class II - Special Controls.

Submitted by Guangzhou Wondfo Biotech Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on November 23, 2015 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3700 - 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: 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

Submission Details

510(k) Number K152495 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 2015
Decision Date November 23, 2015
Days to Decision 83 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
4d faster than avg
Panel avg: 87d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JXN Enzyme Immunoassay, Propoxyphene
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3700
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 - JXN Enzyme Immunoassay, Propoxyphene

All 21
Devices cleared under the same product code (JXN) and FDA review panel - the closest regulatory comparables to K152495.
ONLINE DAT PROPOXYPHENE PLUS
K043303 · Roche Diagnostics Corp. · Mar 2005
PROPOXYPHENE
K013100 · Abbott Laboratories · Mar 2002
SYVA EMIT II PLUS PROPOXYPHENE ASSAY, MODELS 9G029UL/9G129UL
K993981 · Syva Co. · Feb 2000
MODIFICATION TO ABUSCREEN ONLINE FOR PROPOXYPHENE
K983700 · Roche Diagnostic Systems, Inc. · Dec 1998
SYNCHRON SYSTEMS PROPOXYPHENE REAGENT
K955675 · Beckman Instruments, Inc. · Feb 1996
ABUSCREEN ONLINE PROPOXPHENE
K945195 · Roche Diagnostic Systems, Inc. · Dec 1994