Cleared Traditional

K913863 - URINE HEROIN/MORPHINE DIRECT RIA KIT (I...

K913863 is the FDA 510(k) clearance for URINE HEROIN/MORPHINE DIRECT RIA KIT (I... by Immunalysis Corporation. It is a Class 2 Toxicology device (product code DJG) cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K913863 · Immunalysis Corporation · Toxicology device
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Sep 1991
Decision
23d
Days
Class 2
Risk

K913863 is an FDA 510(k) clearance for the URINE HEROIN/MORPHINE DIRECT RIA KIT (I-125). Classified as Enzyme Immunoassay, Opiates (product code DJG), Class II - Special Controls.

Submitted by Immunalysis Corporation (Glendale, US). The FDA issued a Cleared decision on September 19, 1991 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3650 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Immunalysis Corporation devices

Submission Details

510(k) Number K913863 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 1991
Decision Date September 19, 1991
Days to Decision 23 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 87d · This submission: 23d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DJG Enzyme Immunoassay, Opiates
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3650
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 - DJG Enzyme Immunoassay, Opiates

All 136
Devices cleared under the same product code (DJG) and FDA review panel - the closest regulatory comparables to K913863.
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K935117 · Syva Co. · Jan 1994
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K915180 · Diagnostic Reagents, Inc. · Jan 1992
IL TEST(TM) OPIATE
K913742 · Instrumentation Laboratory CO · Nov 1991
ABUSCREEN ONLINE TM FOR OPIATES
K904997 · Roche Diagnostic Systems, Inc. · Dec 1990
BIOSITE DIAGNOSTICS OPIATE SCREENING TEST
K902924 · Biosite Incorporated · Sep 1990
EMIT(R) II OPIATE ASSAY
K902577 · Syva Co. · Jul 1990