Cleared Traditional

K935323 - EMIT IIC COCAINE METABOLITE ASSAY

K935323 is the FDA 510(k) clearance for EMIT IIC COCAINE METABOLITE ASSAY by Syva Co.. It is a Class 2 Toxicology device (product code DIO) cleared through the Traditional 510(k) pathway after a 475-day FDA review.

K935323 · Syva Co. · Toxicology device
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Optimized for regulatory review, auditing and printing
Feb 1995
Decision
475d
Days
Class 2
Risk

K935323 is an FDA 510(k) clearance for the EMIT IIC COCAINE METABOLITE ASSAY. Classified as Enzyme Immunoassay, Cocaine And Cocaine Metabolites (product code DIO), Class II - Special Controls.

Submitted by Syva Co. (San Jose, US). The FDA issued a Cleared decision on February 22, 1995 after a review of 475 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3250 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Toxicology submissions.

View all Syva Co. devices

Submission Details

510(k) Number K935323 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 1993
Decision Date February 22, 1995
Days to Decision 475 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
388d slower than avg
Panel avg: 87d · This submission: 475d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3250
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 - DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites

All 82
Devices cleared under the same product code (DIO) and FDA review panel - the closest regulatory comparables to K935323.
ABUSIGN(TM) DOA 4, DOA, THC/OPI/COC/AMP OR MET, BIOSIGN(TM) DOA 4, THC/OPI/COC/AMP OR MET
K945549 · Princeton BioMeditech Corp. · Oct 1995
ABUSIGN DOA 2, DOA, COC/THC, DOA2, BIOSIGN DOA2, COC/THC
K952361 · Princeton BioMeditech Corp. · Oct 1995
AXSYM COCAINE METABOLITE
K951289 · Abbott Laboratories · Aug 1995
ABUSIGN(TM) COC, DOA-COC, ACCUSIGN(TM) COC, DOA-COC, DIOSIGN(TM) COC, DOA-COC
K945609 · Princeton BioMeditech Corp. · Feb 1995
CEDIA DAU COCAINE ASSAY
K945345 · Microgenics Corp. · Jan 1995
ONTRAK TESTCUP COLLECTION/URINALYSIS PANEL FOR COCAINE, MORPHINE AND THC
K944231 · Roche Diagnostic Systems, Inc. · Dec 1994