Cleared Traditional

K043303 - ONLINE DAT PROPOXYPHENE PLUS

K043303 is the FDA 510(k) clearance for ONLINE DAT PROPOXYPHENE PLUS by Roche Diagnostics Corp.. It is a Class 2 Toxicology device (product code JXN) cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K043303 · Roche Diagnostics Corp. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2005
Decision
101d
Days
Class 2
Risk

K043303 is an FDA 510(k) clearance for the ONLINE DAT PROPOXYPHENE PLUS. Classified as Enzyme Immunoassay, Propoxyphene (product code JXN), Class II - Special Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on March 11, 2005 after a review of 101 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Roche Diagnostics Corp. devices

Submission Details

510(k) Number K043303 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 2004
Decision Date March 11, 2005
Days to Decision 101 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
14d slower than avg
Panel avg: 87d · This submission: 101d
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 Peers - JXN Enzyme Immunoassay, Propoxyphene

All 13
Devices cleared under the same product code (JXN) and FDA review panel - the closest regulatory comparables to K043303.
Wondfo Propoxyphene Urine Test
K152495 · Guangzhou Wondfo Biotech Co., Ltd. · Nov 2015
ACON PPX ONE STEP PROPOXYPHENE TEST STRIP AND ACON PPX STEP PROPOXYPHENE TEST DEVICE
K040445 · ACON Laboratories, Inc. · May 2004
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