Cleared Traditional

K944087 - CX(TM) COCAINE METABOLITE(COCM) REAGENT...

K944087 is an FDA 510(k) clearance for CX(TM) COCAINE METABOLITE(COCM) REAGENT..., manufactured by Beckman Instruments, Inc.. The device is a Class 2 Toxicology device with product code DIO cleared through the Traditional 510(k) pathway after a 148-day FDA review.

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

FDA 510(k) Submission Details - K944087

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.

DIO Device Classification - Class 2, Special Controls

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 92
Devices cleared under the same product code (DIO) and FDA review panel - the closest regulatory comparables to K944087.
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
CEDIA DAU COCAINE ASSAY
K941310 · Microgenics Corp. · Jun 1994
CEDIA DAU COCAINE ASSAY HITACHI 717 AND 704 ANALYZERS
K935904 · Microgenics Corp. · Mar 1994
COCAINE METABOLITE EIA ASSAY MODIFICATION
K935016 · Diagnostic Reagents, Inc. · Dec 1993