Cleared Traditional

K945195 - ABUSCREEN ONLINE PROPOXPHENE

K945195 is the FDA 510(k) clearance for ABUSCREEN ONLINE PROPOXPHENE by Roche Diagnostic Systems, Inc.. It is a Class 2 Toxicology device (product code JXN) cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K945195 · Roche Diagnostic Systems, Inc. · Toxicology device
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Dec 1994
Decision
46d
Days
Class 2
Risk

K945195 is an FDA 510(k) clearance for the ABUSCREEN ONLINE PROPOXPHENE. Classified as Enzyme Immunoassay, Propoxyphene (product code JXN), Class II - Special Controls.

Submitted by Roche Diagnostic Systems, Inc. (Branchburg, US). The FDA issued a Cleared decision on December 9, 1994 after a review of 46 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 Roche Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K945195 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 1994
Decision Date December 09, 1994
Days to Decision 46 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 87d · This submission: 46d
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 16
Devices cleared under the same product code (JXN) and FDA review panel - the closest regulatory comparables to K945195.
MODIFICATION TO ABUSCREEN ONLINE FOR PROPOXYPHENE
K983700 · Roche Diagnostic Systems, Inc. · Dec 1998
SYNCHRON SYSTEMS PROPOXYPHENE REAGENT
K955675 · Beckman Instruments, Inc. · Feb 1996
CEDIA DAU PROPOXYPHENE ASSAY
K951133 · Microgenics Corp. · May 1995
PROPOXPHENE EIA TEST
K943414 · Diagnostic Reagents, Inc. · Sep 1994
SYVA EMIT II PROPOXYPHENE ASSAY
K923873 · Syva Co. · Nov 1992
TDX(R)/TDXFLX(TM) & ADX(R) PROPOXPHENE ASSAYS
K912365 · Abbott Laboratories · Aug 1991