Cleared Traditional

K993981 - SYVA EMIT II PLUS PROPOXYPHENE ASSAY, MODELS 9G029UL/9G129UL

K993981 is an FDA 510(k) clearance for SYVA EMIT II PLUS PROPOXYPHENE ASSAY, manufactured by Syva Co.. The device is a Class 2 Toxicology device with product code JXN cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K993981 · Syva Co. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2000
Decision
69d
Days
Class 2
Risk

K993981 is an FDA 510(k) clearance for the SYVA EMIT II PLUS PROPOXYPHENE ASSAY, MODELS 9G029UL/9G129UL. Classified as Enzyme Immunoassay, Propoxyphene (product code JXN), Class II - Special Controls.

Submitted by Syva Co. (San Jose, US). The FDA issued a Cleared decision on February 1, 2000 after a review of 69 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 Syva Co. devices

FDA 510(k) Submission Details - K993981

510(k) Number K993981 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 1999
Decision Date February 01, 2000
Days to Decision 69 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
18d faster than avg
Panel avg: 87d · This submission: 69d
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 20
Devices cleared under the same product code (JXN) and FDA review panel - the closest regulatory comparables to K993981.
VERDICT-II PROPOXYPHENE
K020787 · Medtox Diagnostics, Inc. · May 2002
PROPOXYPHENE
K013100 · Abbott Laboratories · Mar 2002
MODIFICATION TO THE EMIT II PLUS PROPOXYPHENE ASSAY, MODEL OSR9G229
K011163 · Syva Co., Dade Behring, Inc. · May 2001
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