Cleared Traditional

K935117 - EMIT IIC OPIATE ASSAY

K935117 is the FDA 510(k) clearance for EMIT IIC OPIATE ASSAY by Syva Co.. It is a Class 2 Toxicology device (product code DJG) cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K935117 · Syva Co. · Toxicology device
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Jan 1994
Decision
71d
Days
Class 2
Risk

K935117 is an FDA 510(k) clearance for the EMIT(R) IIC OPIATE ASSAY. Classified as Enzyme Immunoassay, Opiates (product code DJG), Class II - Special Controls.

Submitted by Syva Co. (San Jose, US). The FDA issued a Cleared decision on January 6, 1994 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3650 - 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

Submission Details

510(k) Number K935117 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 1993
Decision Date January 06, 1994
Days to Decision 71 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
16d faster than avg
Panel avg: 87d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DJG Enzyme Immunoassay, Opiates
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3650
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 - DJG Enzyme Immunoassay, Opiates

All 136
Devices cleared under the same product code (DJG) and FDA review panel - the closest regulatory comparables to K935117.
CEDIA DAU OPIATE ASSAY
K945343 · Microgenics Corp. · Jan 1995
CEDIA DAU OPIATE ASSAY
K941195 · Microgenics Corp. · Sep 1994
CEDIA(R) DAU OPIATE ASSAY
K935346 · Microgenics Corp. · Jan 1994
OPIATE EIA ASSAY
K915180 · Diagnostic Reagents, Inc. · Jan 1992
IL TEST(TM) OPIATE
K913742 · Instrumentation Laboratory CO · Nov 1991
URINE HEROIN/MORPHINE DIRECT RIA KIT (I-125)
K913863 · Immunalysis Corporation · Sep 1991