Cleared Traditional

K955935 - TRIAGE PANEL FOR DRUGS OF ABUSE/TRICYCLIC ANTIDEPRESSANTS

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

K955935 · Biosite Incorporated · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K955935

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.

DKZ Device Classification - Class 2, Special Controls

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 184
Devices cleared under the same product code (DKZ) and FDA review panel - the closest regulatory comparables to K955935.
ONE STEP URINE DRUG OF ABUSE METHAMPHETAMINE TEST
K970265 · Drial Consultants, Inc. · Apr 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
AMPHETAMINES MICRO-PLATE EIA
K935573 · Solarcare Technologies Corp,Inc. · Jul 1995
CEDIA DAU AMPHETAMINES ASSAY
K951154 · Microgenics Corp. · May 1995