Cleared Traditional

K923314 - AUTOMATES COMA PLUS COCAINE METABOLITE ASSAY

K923314 is an FDA 510(k) clearance for AUTOMATES COMA PLUS COCAINE METABOLITE ..., manufactured by Serex, Inc.. The device is a Class 2 Toxicology device with product code JXO cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K923314 · Serex, Inc. · Toxicology device
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Aug 1992
Decision
48d
Days
Class 2
Risk

K923314 is an FDA 510(k) clearance for the AUTOMATES COMA PLUS COCAINE METABOLITE ASSAY. Classified as Enzyme Immunoassay, Cocaine (product code JXO), Class II - Special Controls.

Submitted by Serex, Inc. (Maywood, US). The FDA issued a Cleared decision on August 24, 1992 after a review of 48 days - a notably fast clearance cycle.

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: 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 Serex, Inc. devices

FDA 510(k) Submission Details - K923314

510(k) Number K923314 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 1992
Decision Date August 24, 1992
Days to Decision 48 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 87d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JXO Device Classification - Class 2, Special Controls

Product Code JXO Enzyme Immunoassay, Cocaine
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 - JXO Enzyme Immunoassay, Cocaine

Devices cleared under the same product code (JXO) and FDA review panel - the closest regulatory comparables to K923314.
Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in Hair
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STC DIAGNOSTICS AUTO0LYTE COCAINE METABOLITE EIA
K921140 · Solarcare Technologies Corp,Inc. · Aug 1992
STC DIAGNOSTICS BENZOYLECGONINE EIA
K915785 · Solarcare Technologies Corp,Inc. · Mar 1992
IL TEST(TM) COCAINE
K913737 · Instrumentation Laboratory CO · Dec 1991