Cleared Traditional

K022915 - INSTANT-VIEW PROPOXYPHENE (PPX) URINE TEST

K022915 is the FDA 510(k) clearance for INSTANT-VIEW PROPOXYPHENE (PPX) URINE TEST by Alfa Scientific Designs, Inc.. It is a Class 2 Chemistry device (product code JXN) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K022915 · Alfa Scientific Designs, Inc. · Chemistry device
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Optimized for regulatory review, auditing and printing
Nov 2002
Decision
87d
Days
Class 2
Risk

K022915 is an FDA 510(k) clearance for the INSTANT-VIEW PROPOXYPHENE (PPX) URINE TEST. Classified as Enzyme Immunoassay, Propoxyphene (product code JXN), Class II - Special Controls.

Submitted by Alfa Scientific Designs, Inc. (Poway, US). The FDA issued a Cleared decision on November 29, 2002 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3700 - 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 Alfa Scientific Designs, Inc. devices

Submission Details

510(k) Number K022915 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2002
Decision Date November 29, 2002
Days to Decision 87 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
1d faster than avg
Panel avg: 88d · This submission: 87d
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 Chemistry devices follow this clearance model.

Regulatory Peers - JXN Enzyme Immunoassay, Propoxyphene

All 16
Devices cleared under the same product code (JXN) and FDA review panel - the closest regulatory comparables to K022915.
ONLINE DAT PROPOXYPHENE PLUS
K043303 · Roche Diagnostics Corp. · Mar 2005
ACON PPX ONE STEP PROPOXYPHENE TEST STRIP AND ACON PPX STEP PROPOXYPHENE TEST DEVICE
K040445 · ACON Laboratories, Inc. · May 2004
PROPOXYPHENE ENZYME IMMUNOASSAY, CATALOG #0120 (500 TEST KIT), #0121 (5000 TEST KIT)
K023795 · Lin-Zhi International, Inc. · Jan 2003
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