Cleared Traditional

K955935 - TRIAGE PANEL FOR DRUGS OF ABUSE/TRICYCL...

K955935 is the FDA 510(k) clearance for TRIAGE PANEL FOR DRUGS OF ABUSE/TRICYCL... by Biosite Incorporated. It is a Class 2 Toxicology device (product code DKZ) cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K955935 · Biosite Incorporated · Toxicology device
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Feb 1996
Decision
64d
Days
Class 2
Risk

K955935 is an FDA 510(k) clearance for the TRIAGE PANEL FOR DRUGS OF ABUSE/TRICYCLIC ANTIDEPRESSANTS. Classified as Enzyme Immunoassay, Amphetamine (product code DKZ), Class II - Special Controls.

Submitted by Biosite Incorporated (San Diego, US). The FDA issued a Cleared decision on February 15, 1996 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3100 - 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 Biosite Incorporated devices

Submission Details

510(k) Number K955935 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1995
Decision Date February 15, 1996
Days to Decision 64 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
23d faster than avg
Panel avg: 87d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DKZ Enzyme Immunoassay, Amphetamine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3100
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 - DKZ Enzyme Immunoassay, Amphetamine

All 125
Devices cleared under the same product code (DKZ) and FDA review panel - the closest regulatory comparables to K955935.
ABUSCREEN ONLINE FOR AMPHETAMINES WITH PERIODATE - OLYMPUS AU800/1000 INSTRUMENT APPLICATION
K972891 · Roche Diagnostic Systems, Inc. · Oct 1997
ONTRAK TESTCUP AMPHETAMINES
K962411 · Roche Diagnostic Systems, Inc. · Oct 1996
TRIAGE PANEL FOR DRUGS OF ABUSE MODEL 9500/93000
K955934 · Biosite Incorporated · Feb 1996
AXSYM AMPHETAMINE/METHAMPHETAMINE II
K953115 · Abbott Laboratories · Oct 1995
CEDIA DAU AMPHETAMINES ASSAY
K951154 · Microgenics Corp. · May 1995
ABUSIGN(TM) AMP, DOA-AMP, ACCUSIGN(TM) AMP-DOA-AMP, BIOSIGN(TM) AMP, DOA-AMP
K945610 · Princeton BioMeditech Corp. · Apr 1995