Cleared Traditional

K880674 - MICROMEDIC CRACKPOT RIA KIT

K880674 is an FDA 510(k) clearance for MICROMEDIC CRACKPOT RIA KIT, manufactured by Icn Micromedic Systems. The device is a Class 2 Toxicology device with product code KLN cleared through the Traditional 510(k) pathway after a 230-day FDA review.

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

FDA 510(k) Submission Details - K880674

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.

KLN Device Classification - Class 2, Special Controls

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 12
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
RESUB. URINE COCAINE META. DIRECT RIA KIT [I-125]
K871549 · Immunalysis Corporation · Jun 1987
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