Cleared Special

MODIFICATION TO THE EMIT II PLUS PROPOXYPHENE ASSAY, MODEL OSR9G229 (K011163) - FDA 510(k) Clearance

Class II Chemistry device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K011163 · Syva Co., Dade Behring, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2001
Decision
24d
Days
Class 2
Risk

K011163 is an FDA 510(k) clearance for the MODIFICATION TO THE EMIT II PLUS PROPOXYPHENE ASSAY, MODEL OSR9G229. Classified as Enzyme Immunoassay, Propoxyphene (product code JXN), Class II - Special Controls.

Submitted by Syva Co., Dade Behring, Inc. (San Jose, US). The FDA issued a Cleared decision on May 10, 2001 after a review of 24 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Syva Co., Dade Behring, Inc. devices

Submission Details

510(k) Number K011163 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 2001
Decision Date May 10, 2001
Days to Decision 24 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 88d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

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 21
Devices cleared under the same product code (JXN) and FDA review panel - the closest regulatory comparables to K011163.
Wondfo Propoxyphene Urine Test
K152495 · Guangzhou Wondfo Biotech Co., Ltd. · Nov 2015
PROPOXYPHENE
K013100 · Abbott Laboratories · Mar 2002
SYVA EMIT II PLUS PROPOXYPHENE ASSAY, MODELS 9G029UL/9G129UL
K993981 · Syva Co. · Feb 2000
SYVA EMIT II PROPOXYPHENE ASSAY
K923873 · Syva Co. · Nov 1992
TDX(R)/TDXFLX(TM) & ADX(R) PROPOXPHENE ASSAYS
K912365 · Abbott Laboratories · Aug 1991
REVISED LABELING FOR SYVA PROPOXYPHENE ASSAYS
K874200 · Syva Co. · Oct 1987