Cleared Traditional

K951133 - CEDIA DAU PROPOXYPHENE ASSAY

K951133 is the FDA 510(k) clearance for CEDIA DAU PROPOXYPHENE ASSAY by Microgenics Corp.. It is a Class 2 Toxicology device (product code JXN) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K951133 · Microgenics Corp. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1995
Decision
50d
Days
Class 2
Risk

K951133 is an FDA 510(k) clearance for the CEDIA DAU PROPOXYPHENE ASSAY. Classified as Enzyme Immunoassay, Propoxyphene (product code JXN), Class II - Special Controls.

Submitted by Microgenics Corp. (Concord, US). The FDA issued a Cleared decision on May 2, 1995 after a review of 50 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 Microgenics Corp. devices

Submission Details

510(k) Number K951133 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 1995
Decision Date May 02, 1995
Days to Decision 50 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
37d faster than avg
Panel avg: 87d · This submission: 50d
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 K951133.
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
PROPOXPHENE EIA TEST
K943414 · Diagnostic Reagents, Inc. · Sep 1994
SYVA EMIT II PROPOXYPHENE ASSAY
K923873 · Syva Co. · Nov 1992