Cleared Traditional

K881102 - MICROMEDIC MORPHINE RIA KIT

K881102 is an FDA 510(k) clearance for MICROMEDIC MORPHINE RIA KIT, manufactured by Icn Micromedic Systems. The device is a Class 2 Toxicology device with product code DOE cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K881102 · Icn Micromedic Systems · Toxicology device
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Jun 1988
Decision
101d
Days
Class 2
Risk

K881102 is an FDA 510(k) clearance for the MICROMEDIC MORPHINE RIA KIT. Classified as Radioimmunoassay, Morphine (125-i), Goat Antibody Ammonium Sulfate Sep. (product code DOE), Class II - Special Controls.

Submitted by Icn Micromedic Systems (Horsham, US). The FDA issued a Cleared decision on June 24, 1988 after a review of 101 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3640 - 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 - K881102

510(k) Number K881102 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 1988
Decision Date June 24, 1988
Days to Decision 101 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d slower than avg
Panel avg: 87d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DOE Device Classification - Class 2, Special Controls

Product Code DOE Radioimmunoassay, Morphine (125-i), Goat Antibody Ammonium Sulfate Sep.
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3640
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 - DOE Radioimmunoassay, Morphine (125-i), Goat Antibody Ammonium Sulfate Sep.

All 9
Devices cleared under the same product code (DOE) and FDA review panel - the closest regulatory comparables to K881102.
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K951319 · Roche Diagnostic Systems, Inc. · Jun 1995
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K935055 · Roche Diagnostic Systems, Inc. · Aug 1994
URINE HEROIN/MORPHINE DIRECT RIA KIT (I-125)
K933572 · Immunalysis Corporation · Apr 1994
THE DPC COAT-A-COUNT SERUM MORPHINE RIA KIT
K863913 · Diagnostic Products Corp. · Mar 1987
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K864168 · Roche Diagnostic Systems, Inc. · Mar 1987
ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE
K830460 · Hoffmann-La Roche, Inc. · Mar 1983