Cleared Traditional

CX(TM) COCAINE METABOLITE(COCM) REAGENT/SYNCHRON CX SYS (K944087) - FDA 510(k) Clearance

Class II Toxicology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K944087 · Beckman Instruments, Inc. · Toxicology device
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Nov 1994
Decision
148d
Days
Class 2
Risk

K944087 is an FDA 510(k) clearance for the CX(TM) COCAINE METABOLITE(COCM) REAGENT/SYNCHRON CX SYS. Classified as Enzyme Immunoassay, Cocaine And Cocaine Metabolites (product code DIO), Class II - Special Controls.

Submitted by Beckman Instruments, Inc. (Brea, US). The FDA issued a Cleared decision on November 30, 1994 after a review of 148 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Beckman Instruments, Inc. devices

Submission Details

510(k) Number K944087 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 1994
Decision Date November 30, 1994
Days to Decision 148 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
61d slower than avg
Panel avg: 87d · This submission: 148d
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 44
Devices cleared under the same product code (DIO) and FDA review panel - the closest regulatory comparables to K944087.
AXSYM COCAINE METABOLITE
K951289 · Abbott Laboratories · Aug 1995
EMIT IIC COCAINE METABOLITE ASSAY
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ONTRAK TESTCUP COLLECTION/URINALYSIS PANEL FOR COCAINE, MORPHINE AND THC
K944231 · Roche Diagnostic Systems, Inc. · Dec 1994
ABUSCREEN ONLINE(R) FOR COCAINE METABOLITE, MODIF
K933053 · Roche Diagnostic Systems, Inc. · Aug 1993
SYVA EMIT D.A.U. COCAINE METABOLITE
K914973 · Syva Co. · Nov 1991
EMIT(R) II COCAINE METABOLITE ASSAY
K902579 · Syva Co. · Jul 1990