Cleared Traditional

MICROMEDIC CRACKPOT RIA KIT (K880674) - FDA 510(k) Clearance

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

K880674 · Icn Micromedic Systems · Toxicology device
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Oct 1988
Decision
230d
Days
Class 2
Risk

K880674 is an FDA 510(k) clearance for the MICROMEDIC CRACKPOT RIA KIT. Classified as Radioimmunoassay, Cocaine Metabolite (product code KLN), Class II - Special Controls.

Submitted by Icn Micromedic Systems (Horsham, US). The FDA issued a Cleared decision on October 6, 1988 after a review of 230 days - an extended review 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: 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 Icn Micromedic Systems devices

Submission Details

510(k) Number K880674 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 1988
Decision Date October 06, 1988
Days to Decision 230 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
143d slower than avg
Panel avg: 87d · This submission: 230d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KLN Radioimmunoassay, Cocaine Metabolite
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 - KLN Radioimmunoassay, Cocaine Metabolite

All 7
Devices cleared under the same product code (KLN) and FDA review panel - the closest regulatory comparables to K880674.
MILENIA COCAINE METABOLITE
K910044 · Diagnostic Products Corp. · Feb 1991
ABUSCREEN ONTRAK FOR COCAINE (200NG/ML)
K905730 · Roche Diagnostic Systems, Inc. · Jan 1991
ABUSCREEN ONLINE TM FOR COCAINE METABOLITE
K904995 · Roche Diagnostic Systems, Inc. · Nov 1990
COAT-A-COUNT COCAINE METABOLITE TKCN1 & TKCN5
K870740 · Diagnostic Products Corp. · Mar 1987
DOUBLE ANTIBODY COCAINE METABOLITE RIA KIT
K862218 · Diagnostic Products Corp. · Jun 1986