Cleared Traditional

K013100 - PROPOXYPHENE

K013100 is an FDA 510(k) clearance for PROPOXYPHENE, manufactured by Abbott Laboratories. The device is a Class 2 Toxicology device with product code JXN cleared through the Traditional 510(k) pathway after a 184-day FDA review.

K013100 · Abbott Laboratories · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2002
Decision
184d
Days
Class 2
Risk

K013100 is an FDA 510(k) clearance for the PROPOXYPHENE. Classified as Enzyme Immunoassay, Propoxyphene (product code JXN), Class II - Special Controls.

Submitted by Abbott Laboratories (Irving, US). The FDA issued a Cleared decision on March 20, 2002 after a review of 184 days - an extended review 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: 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K013100

510(k) Number K013100 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2001
Decision Date March 20, 2002
Days to Decision 184 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
97d slower than avg
Panel avg: 87d · This submission: 184d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JXN Device Classification - Class 2, Special Controls

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 17
Devices cleared under the same product code (JXN) and FDA review panel - the closest regulatory comparables to K013100.
'RAPID ONE' - PROPOXYPHENE TEST
K030835 · American Bio Medica Corp. · May 2003
PROPOXYPHENE ENZYME IMMUNOASSAY, CATALOG #0120 (500 TEST KIT), #0121 (5000 TEST KIT)
K023795 · Lin-Zhi International, Inc. · Jan 2003
INSTANT-VIEW PROPOXYPHENE (PPX) URINE TEST
K022915 · Alfa Scientific Designs, Inc. · Nov 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